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Special Focus: Refractive Laser 4 Cover story: LAsiK experts discuss the future of the procedure8 Advances in surface ablation techniques9 Laser technology effective for treating high myopia10 success reported with hyperopic LAsiK

Cataract & Refractive 12 Laser or lens for high myopia?13 study shows less endothelial cell loss at six months with new technology14 New system helps advance cataract surgery15 hygiene big factor in preventing endophthalmitis16 screening key to selection of phakic iOL candidates

Cornea 18 Tonometry after DsEK19 Case study shows successful treatment options for corneal melts20 New therapies for epithelial corneal disease 21 is combined approach best for treating cataracts in Fuchs’ Dystrophy patients?

Glaucoma 22 Combined procedure effective for reducing iOP24 Pathobiology of glaucomatous damage explored26 Cataract surgery in glaucoma patients

Retina 27 Recent advances of gene therapy for genetic disease treatment

Paediatric Ophthalmology 28 Multisectoral approach needed to reduce burden of childhood blindness

News 30 EBO Diploma 2012 attracts record number of candidates32 Young Ophthalmologists need to develop business skills

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JULY/AUGUST 2012Volume 17 | Issue 7/8

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Features 33 Book Review34 Practice Development34 Journal Watch35 Ophthalmologica highlights 36 EU Matters37 industry News39 JCRs highlights40 Calendar

With this month’s issue... Milan 2012 PREViEW OF 3RD EUCORnEa COnGRESS, 12th EUREtina COnGRESS, & 2nD WORlD COnGRESS OF PaEDiatRiC OPhthalMOlOGY anD StRaBiSMUS, XXX COnGRESS OF thE ESCRS

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Published by the European Society of Cataract and Refractive Surgeons Temple House, Temple Road, Blackrock, Co Dublin, Ireland. No part of this publication may be reproduced without the permission of the managing editor. Letters to the editor and other unsolicited contributions are assumed intended for this publication and are subject to editorial review and acceptance.

ESCRS EuroTimes is not responsible for statements made by any contributor. These contributions are presented for review and comment and not as a statement on the standard of care. Although all advertising material is expected to conform to ethical medical standards, acceptance does not imply endorsement by ESCRS EuroTimes.ISSN 1393-8983

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Published byThe European Society of Cataract and Refractive Surgeons

As certified by ABC, the EuroTimes aver-age net circulation for the 11 issues distributed between 01 January 2011 and 31 December 2011 is 32,332.

Cover image: Epithelial ingrowth after a flap lift LASIK enhancement.

Image courtesy of Christopher J Rapuano MD.

by Thomas Kohnen

This month’s issue of EuroTimes is devoted to refractive laser surgery and features a number of stimulating articles on the subject. Our Cover story focuses on the issue of complications in LAsiK surgery and looks at how advances

in technology and surgical techniques, allied to more rigorous patient selection, have helped to reduce the more common complications associated with refractive laser surgery.

There seems to be a broad consensus that the introduction of the femtosecond laser has played a major role in reducing intraoperative flap-related complications associated with LAsiK surgery. Certainly, that view accords with my own personal experience. since making the transition to femtosecond-laser assisted LAsiK in 2006, i have experienced none of the issues with buttonholes, torn or incomplete flaps that we regularly encountered with flap creation using mechanical microkeratomes. The ability of the femtosecond laser to deliver a more regular and accurate flap architecture has also largely eliminated problems of epithelial ingrowth that occurred regularly with mechanical blades in primary LAsiK procedures.

A fundamental factor in reducing the complications associated with LAsiK has been better patient selection. This essentially means respecting the safety limits concerning the correction of higher refractive errors, limiting myopic LAsiK treatments up to around -8.0 D or very rarely -10.0 D and up to +3.0 or 3.5 D in the hyperopic range. My own personal view is that it is better to err on the side of caution and to never go above these thresholds, because there are other viable and safe refractive options such as phakic iOLs or refractive lens exchange for those patients that fall outside the safe limits for LAsiK.

While corneal ectasia remains one of the most feared complications of refractive corneal laser surgery, we have seen significant progress in reducing its incidence in recent years. This again is down to more careful screening of patients, the use of thinner femtosecond flaps, and better use and understanding of corneal topography and wavefront aberrometry to identify forme fruste keratoconus at an early stage. Patients with a combination of high vertical coma values and abnormal topography present a higher risk of ectasia and are not good candidates for LAsiK.

As technology progresses very quickly, there is an understandable trend towards speeding up refractive surgical procedures and perhaps taking less time than we should to analyse fully each patient’s needs and goals. We need to resist this temptation to rush things and never forget that we are dealing with the most important visual organ of the human body. The bottom line is that if we don’t take our time at all phases of the preoperative, intraoperative and postoperative care of our patients, we inevitably increase the risk of complications.

There is no doubt that enhanced laser technology has yielded considerable progress in recent years. in addition to better flap creation with the femtosecond laser, important advances in aspheric ablation profiles have also helped to reduce the problems of glare, haloes and night vision issues that occasionally occurred with first-

generation LAsiK treatments. i now almost exclusively use aspheric profiles with larger optical zones if the mesopic pupil size is too large. As a result, i very rarely see any mesopic-related problems and this has been a significant evolution for the quality of vision of our patients.

Moving forward, we are likely to see continued advances in excimer laser technology in the years ahead. The technology is increasingly sophisticated but there is always scope for improvement. Better integration of preoperative data with the actual laser ablation would be of immediate benefit to refractive surgeons, as would efforts to combine the femtosecond and excimer lasers in one seamless platform. LAsiK has come a long way in a relatively short period of time. i have every confidence that improved technology, better patient selection and refined surgical techniques will continue to translate into a reduced rate of complications and better outcomes for our refractive surgery patients in the future.

THOMAS KOHNEN

Thomas Kohnen MD, PhD, FEBO

EUROTIMES | Volume 17 | Issue 7/8

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EDITORIAL Volume 17 | Issue 7/8

Editorial

ERR ON SIDE OF CAUTIONViable and safe refractive options should be considered for patients outside the safe limits for LASIK

José Güell

Clive Peckar

Emanuel RosenChairman

ESCRS Publications Committee

Ioannis Pallikaris

Paul Rosen

Medical Editors

International Editorial Board

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noel alpins australia

Bekir aslan turKEY

Bill aylward uK

Peter Barry irElaND

Roberto Bellucci italY

hiroko Bissen-Miyajima JaPaN

John Chang CHiNa

Joseph Colin FraNCE

alaa El Danasoury sauDi araBia

Oliver Findl austria

i howard Fine usa

Jack holladay usa

Vikentia Katsanevaki GrEECE

thomas Kohnen GErMaNY

anastasios Konstas GrEECE

Dennis lam HONG KONG

Boris Malyugin russia Marguerite McDonald usa

Cyres Mehta iNDia

thomas neuhann GErMaNY

Rudy nuijts tHE NEtHErlaNDs

Gisbert Richard GErMaNY

Robert Stegmann sOutH aFriCa

Ulf Stenevi sWEDEN

Emrullah tasindi turKEY

Marie-Jose tassignon BElGiuM

Manfred tetz GErMaNY

Carlo Enrico traverso italY

Roberto Zaldivar arGENtiNa

Oliver Zeitz GErMaNY

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by Dermot McGrath

QUEST FOR PERFECTION

Laser-assisted in situ keratomileusis (LAsiK) has been assessed and improved by more than a decade of clinical

studies and technological innovation since the procedure was first introduced. As one of the most popular elective surgical procedures in the world, with one of the highest safety profiles, LAsiK remains the primary dynamo driving today’s global refractive surgery market.

however, given the huge volume of procedures performed since its inception, with an estimated 17 million procedures in the Us alone, it is hardly surprising that LAsiK complication rates have attained a higher visibility than many other refractive surgery procedures.

Even allowing for high overall patient satisfaction rates for LAsiK of around 95.4 per cent – based on Dr Kerry solomon et al’s 2008 meta-analysis of 19 studies from 13 countries encompassing 2,198 patients who underwent LAsiK between 1995 and 2003 (Ophthalmology. 2009 Apr;116(4):691-701) – the remaining 4.6 per cent equates to a sizeable and frequently vocal minority of dissatisfied patients.

The type of complications that determine which patients end up in the disgruntled minority are familiar to all refractive surgeons. Corneal ectasia, dry eye syndrome, epithelial ingrowth, buttonholes, free caps, night vision problems, haloes, glare, regression, decentred ablation, light sensitivity, inflammation, infection, make up a representative but far from exhaustive list of the more common complications associated with the procedure.

While many of these complications are known to resolve spontaneously or after treatment in the first six months or so after surgery, a small percentage of patients, for whom re-treatment or enhancement is not an option, may face enduring or lifelong problems associated with their LAsiK surgery.

Although there are no reliable figures for

how many patients fall under the terminally dissatisfied category over the long term, the fact that the FDA in the Us received just 140 “negative reports relating to LAsiK” for the time period 1998-2006 suggests to some observers that LAsiK complication and/or dissatisfaction rates are probably under-reported.

A 2008 study on LAsiK complications carried out at Wills Eye institute (J Cataract Refract Surg. 2008 Jan;34(1):32-9.), for instance, found that only 29 per cent of patients referred for problems after LAsiK were referred by their LAsiK surgeon, and a majority (54 per cent) were referred by another eye doctor, while 17 per cent sought a second opinion themselves by searching the internet or asking friends for referrals.

Christopher J Rapuano MD, lead author of the Wills study on LAsiK complications and director of the Cornea service and co-director of the Refractive surgery Department at Wills Eye institute, told EuroTimes that many patients clearly felt uncomfortable “complaining” to their own surgeons, so often sought a second opinion, even soon after surgery.

“i still believe many patients disappear from their surgeon’s practices after the one year of ‘free’ follow-up care that most provide. Consequently, i do believe we have been underestimating refractive surgery complications. having said that, i have not been seeing as many patients with complaints after refractive surgery over the past few years as before. That may be because we surgeons are getting better at it, or perhaps that fewer refractive cases are being done because of the economic situation, or both,” he said.

Technology advances Whatever about the economic context, the general consensus from refractive surgeons is that advances in laser technology allied to more rigorous patient selection have definitely contributed to a reduction in LAsiK

complication rates in recent years.“There has definitely been an

improvement over the past few years which i would attribute to improved technology, with better preoperative diagnostics and also much better patient screening in terms of anterior and posterior surface, corneal thickness, and even family history to help prevent complications such as post-LAsiK ectasia,” said Francesco Carones MD, Co-founder and medical director of the Carones Ophthalmology Centre in Milan, italy.

in Dr Carones’ view, the introduction of the femtosecond laser has played a fundamental role in reducing flap-related complications and corneal ectasia.

“The thinner flaps and predictable thickness of flap creation with the femtosecond laser has undoubtedly contributed to the reduction in post-LAsiK ectasia. i started using the femtosecond laser in 2006 and i have had absolutely no ectasia cases since making the switch from the mechanical microkeratome. intraoperative pachymetry has also helped in this regard, even though the benefit is probably as much psychological as practical since we have usually found very little deviation from the intended flap thickness anyway,” Dr Carones told EuroTimes.

Michael Knorz MD, medical director of the FreeVis LAsiK Centre in Mannheim, Germany, also highlighted the improvement in excimer laser technology with much better ablation algorithms now available compared to first-generation laser devices.

“Modern lasers now more or less all use either aspheric ablations or wavefront-guided ablations. surgeons also increasingly understand that optical zones should not be small in order to save tissue, but sufficiently large to provide better quality of vision. This has definitely improved the optical quality of the outcomes,” he said.

Prof Knorz also emphasised the hard lesson that has been learnt over the years

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LASIK banks on mature technology and reduced complication rates to stay ahead of the competition

EUROTIMES | Volume 17 | Issue 7/8

Cover Story

REFRACTIVE LASER

I still believe many patients disappear from their surgeon’s practices after the one year of ‘free’ follow-up care that most provide. Consequently, I do believe we have been underestimating refractive surgery complications

“

Christopher J Rapuano MD

The thinner flaps and predictable thickness of flap creation with the femtosecond laser has undoubtedly contributed to the reduction in post-LASIK ectasia

“

Francesco Carones MD

in trying to push the limits of excimer laser ablation for high myopes or hyperopes.

“in terms of patient selection, we have learned a lot about the poor optics created by the correction of higher refractive errors and subsequently have stopped treating these patients with LAsiK,” he said.

Allon Barsam MA, FRCOphth, a cornea and refractive surgeon at the L&D University hospital and the Western Eye hospital in London, UK, agrees that better patient selection has made a critical difference in reducing LAsiK-induced complications such as corneal ectasia.

“We now have much better imaging technology for improved detection of ectasia and forme fruste keratoconus, and are much more proficient at interpreting the topographical data that we obtain and screening out suspect cases,” he said. Characterising patient factors such as young age, residual stromal bed, corneal thickness and so forth have also improved outcomes and helped to reduce the risk of postoperative complications, he added.

Flap-complications diminishing As well as reducing the risk of ectasia, the traditional roll-call of flap-related complications such as free caps, buttonholes, partial flaps, flap striae and decentred flaps, have all but disappeared with the introduction of the femtosecond laser, added Dr Barsam.

“These complications are now very rare indeed with the femtosecond laser in the hands of a well-trained, experienced and skilled laser eye surgeon using the most modern technology,” he said.

Although a marked improvement on mechanical microkeratomes, the femtosecond laser is not completely immune from complications associated with its use, points out Amar Agarwal Ms, FRCs, FRCOphth, director of the Eye Research Centre & Dr Agarwal’s Group of Eye hospitals in Chennai, india.

“The femtosecond laser is definitely better than the blade microkeratome but it is not absolutely free from any complications. For instance, it is possible to create a decentred flap, which is usually attributed to surgical error, and there are also potential issues with suction loss

leading to incomplete or irregular flap as well,” he said.

Other potential intraoperative issues related to the femtosecond laser have also been reported, including opaque bubble layer, anterior chamber bubbles and vertical gas breakthrough.

Epithelial ingrowth is yet another complication that may still occur with femtosecond use, added Dr Agarwal, although its incidence is less than with mechanical microkeratomes.

“The best solution for this is to lift the flap, clean it and apply fibrin glue at the edge of the flap which will prevent any further ingrowth occurring. Another effective option is to perform YAG laser as suggested by Jorge Alio. This low-energy procedure uses the YAG laser to spare patients more invasive surgery and avoid the risks of further complications from a flap lift,” he said.

Dry eye still an issue The perennial issue of dry eye syndrome is another complication that has the potential to cause problems after LAsiK, irrespective of whether the flap has been created by blade or laser, said howard M Neff MD, director of refractive surgery, henry Ford health system, Michigan, Us.

“i think dry eye remains one of the major complications of LAsiK. For many patients, the problem usually resolves with treatment a few months after LAsiK, but i have certainly seen a small percentage of people where the dry eye persists and they are still complaining years down the road,” he said.

To head off potential problems with dry eye, Dr Neff said he pays close attention to the tear film and ocular surface in preoperative assessment and prescribes topical administration of cyclosporine (Restasis, Allergan inc.) for four to six weeks before surgery if signs of dry eye are present.

The pervasiveness of the dry eye issue was also borne out by the Wills Eye institute study, with ocular dryness (19 per cent) reported as the second most frequent complaint of patients unhappy with refractive surgery. The study authors noted that patients with persistent dry eyes after

LAsiK were among the unhappiest of all patients.

Despite ongoing problems with dry eye, the situation has probably improved somewhat since 2008, believes Dr Rapuano.

“i think surgeons are much more aware these days that dry eye syndrome is an issue and we are screening out patients better. We are also doing a better job telling patients before surgery about the possibility of dry eye. Additionally, i think we are being more aggressive both pre-op and post-op in treating these patients with cyclosporine, plugs and so forth,” he said.

While surface ablation procedures have been touted as less likely to induce dry eye than LAsiK, Dr Carones said that he has not noticed any significant difference between PRK and LAsiK.

“i think the dry eye problem is more related to the excimer laser than the flap. This issue has taken on such a proportion because of the high volume of LAsiK especially in the United states and Europe, so everybody attributed the responsibility of the dry eye to LAsiK. But if we look at those countries where PRK has been performed on a routine basis as a primary procedure in a lot of public hospitals we know that dry eye may occur as well,” he said.

Quality of vision Another commonly reported complaint after LAsiK, particularly for those patients treated with early versions of the excimer laser, related to quality of vision issues such as night vision difficulties, glare and haloes. This was reflected in a 2005 study (J Cataract Refract Surg. 2005 Oct; 31(10):1943-51.) conducted at the Academic hospital Maastricht in The Netherlands, for instance, which found that night vision was considered worse or much worse than before surgery by 33.8 per cent of patients.

seven years on from that study, Rudy Nuijts MD, PhD, who was one of the co-authors of the research, believes that the figure would be significantly reduced today thanks to improved technology.

“Those were the days when we had big issues in terms of tissue consumption on some of the old lasers and where we could not go out far in terms of optical zone size. That meant that while providing a

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EUROTIMES | Volume 17 | Issue 7/8

In terms of patient selection, we have learned a lot about the poor optics created by the correction of higher refractive errors and subsequently have stopped treating these patients with LASIK

“

Michael Knorz MD

We now have much better imaging technology for improved detection of ectasia and forme fruste keratoconus, and are much more proficient at interpreting the topographical data that we obtain and screening out suspect cases

“

Allon Barsam MA, FRCOphth

Epithelial ingrowth Flap tear

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EUROTIMES | Volume 17 | Issue 7/8

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REFRACTIVE LASER

Cover StoryAmar Agarwal – dragarwal@vsnl.comAllon Barsam – abarsam@hotmail.comFrancesco Carones – fcarones@carones.comMichael C Knorz – knorz@eyes.deRudy Nuijts – rudy.nuijts@mumc.nlHoward Neff – hneff1@hfhs.orgChristopher J Rapuano – cjrapuano@willseye.org

cont

acts

certain level of correction to patients we had to limit the optical zone size to go deep enough into the cornea – that was the necessary trade off, making the optical zone quite small in relation to the patients’ mesopic pupil. i believe that was one of the causes of the high incidence of night visions complaints that we had back then,” he said.

Dr Nuijts believes that thinner femtosecond flaps have definitely helped in this respect.

“With the femtosecond laser we can make smaller flaps in the region of 110 microns leaving us with a thicker cornea for creating the ablation and enabling us to go out further to the periphery. Another improvement has been the modification in ablation zone algorithms which allow us to use wider optical zones and improve our outcomes,” he said.

To avoid the risk of photic phenomena, Dr Nuijts advocates a conservative approach in terms of pupil size.

“i think some of these problems with haloes and glare are down to the fact that some surgeons push the limits. i still believe that you have to respect the mesopic pupil size, and even though some surgeons are quite happy to treat 8.0mm pupils, i tend to be more conservative and stay within the limits because in my experience it can cause problems with postoperative quality of vision,” he said.

Future trends Looking to the future, refractive surgeons say they are confident that the ongoing advances in technology will continue to raise standards, reduce complications and improve visual outcomes for patients.

This will ultimately mean faster, safer lasers, with more diagnostic bells and whistles, and greater interoperability between devices.

“Every laser system has its unique selling point and the companies all sell their lasers based on that particular capability,” noted Dr Barsam, who said he would ideally like to see a single system that incorporates all of the best features of the various models currently available.

Dr Neff said that better iris registration capability would be appreciated on his own laser system.

“The current iris registration is great when it works but there are a small percentage of patients in the range of around five per cent where we cannot get a good registration. it would be nice if it were a little more reliable than that,” he said.

For Dr Agarwal, the number one priority would be to improve the reliability of aberrometry technology.

“What i would really like is to have a better aberrometry machine which can diagnose any small aberration that could then be corrected and treatable on the excimer laser. if these aberrometers are seamlessly linked to the excimer laser, it

will allow us to better fine-tune the quality of vision,” he said.

Dr Carones said that he would also like to see a single platform capable of performing all the necessary steps in refractive surgery procedures, as well as greater interoperability between all the various technologies that make up the average refractive surgery practice.

in terms of future developments, Prof Knorz said that the good news is that the pace of innovation shows no sign of slackening in the coming years.

“i expect to see new lasers designed to create corneal flaps such as the nanosecond laser being developed by schwind which offers a new approach that could prove exciting. We will also see the further development of multi-purpose platforms such as the Bausch + Lomb/Technolas ViCTUs and the Alcon Lensx system which are able to perform flaps, AK-cuts and cataract surgery,” he said.

improved eye tracking and iris registration would also be a welcome boon to refractive surgeons, said Prof Knorz. “We really need to address tilt and rotation of the eye, and we have to make sure that the treatment is delivered exactly at the right place,” he said.

With the increasing trend towards ever-more sophisticated technology, some surgeons have warned of the danger of refractive surgery shifting towards a primarily ‘technical’ procedure in which surgical skills play second fiddle to machine-driven automation.

Dr Agarwal, however, believes that surgeons should embrace rather than resist the possibilities of technology and not be afraid to move with changing trends.

“i think the future will still see surgical skills at the heart of our refractive and cataract practices, despite all the trends towards automation. While you might have the best machine in the world, it will make no difference if the surgeon who is operating it does not know what he or she is doing. They need to be able to use their experience, to analyse the condition, the individual needs of the patient and weigh so many factors to decide on the optimal treatment. The machine helps of course, but if i have to make a choice, i will choose a doctor ahead of a machine every time,” he concluded.

With the increasing trend towards ever-more sophisticated technology, some surgeons have warned of the danger of refractive surgery shifting towards a primarily ‘technical’ procedure in which surgical skills play second fiddle to machine-driven automation

I have certainly seen a small percentage of people where the dry eye persists and they are still complaining years down the road

“

Howard M Neff MD

I think some of these problems with haloes and glare are down to the fact that some surgeons push the limits. I still believe that you have to respect the mesopic pupil size

“

Rudy Nuijts MD, PhD

While you might have the best machine in the world, it will make no difference if the surgeon who is operating it does not know what he or she is doing

“

Amar Agarwal MS, FRCS, FRCOphth

Don’t miss EBO Diploma success stories, see page 30

Epithelial ingrowth after a flap lift LASIK enhancement

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VMA: » May lead to symptoms such as metamorphopsia,

decreased visual acuity, and central visual field defect2

» Can cause traction resulting in anatomical damage, which may lead to severe visual consequences, including3,4

• Macular hole3

• Retinal tear/detachment4

Symptomatic VMAA Disease That’s Gaining Traction

RefeRences1. Schneider EW, Johnson MW. Emerging nonsurgical methods for the treatment of vitreomacular adhesion: a review. Clin Ophthalmol. 2011;5:1151-65. 2. Steidl SM, Hartnett ME. Clinical pathways in vitreoretinal disease. New York: Thieme Medical Publishers; 2003. Chapter 17; 263-86. 3. Gallemore RP, Jumper JM, McCuen BW 2nd, Jaffe GJ, Postel EA, Toth CA. Diagnosis of vitreoretinal adhesions in macular disease with optical coherence tomography. Retina. 2000;20(2):115-20. 4. Mitry D, Fleck BW, Wright AF, Campbell H, Charteris DG. Pathogenesis of Rhegmatogenous Retinal Detachment: Predisposing Anatomy and Cell Biology. Retina. 2010 Nov–Dec;30(10):1561–72.

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EUROTIMES | Volume 17 | Issue 7/8

Advances in excimer laser technology and improved intraoperative and postoperative therapies make surface ablation

a viable alternative for those patients where other refractive laser procedures are contraindicated, Francesco Carones MD told delegates attending the World Ophthalmology Congress.

“improvements in recent years have helped to overcome some of the known disadvantages of surface ablation techniques including pain, slow recovery and wound healing-related issues such as haze and regression. We have seen advances in laser technology, ablation profiles, surgical techniques and intraoperative and postoperative therapy that are helping to overcome these issues,” he said.

Dr Carones, medical director of the Carones Ophthalmology Centre in Milan, italy, said that there are several key factors to bear in mind in order to achieve optimal results in surface ablation procedures.

“One of the most important issues for me is the amount of tissue removed because this is directly correlated to the wound healing process which leads to haze and regression. We also need to be careful in terms of ensuring adequate residual stromal bed thickness, because even with PRK it is possible to see cases of ectasia,” he said.

Safe limits Dr Carones said that the safe limits for tissue removal depend upon whether the surgeon is using antimetabolites or not.

“if we limit our ablations to 80 to 100 microns without using metabolites, we can be on the safe side and be able to correct myopia up to -6 D or -7 D, astigmatism between 2.0 to 2.5 D and hyperopia up to +2.5 D. if we use antimetabolites like mitomycin C we may extend the amount of tissue removed up to 150 microns in a safe manner and bring our limits for correcting myopia up to -10 D, astigmatism up to 4.0 D as well as hyperopia up to +4 D,” he said.

Dr Carones advised leaving a minimum residual stromal bed thickness of at least 300 microns after the ablation to stay within safe limits.

Particular attention should also be paid to patients with suspect topography, forme fruste keratoconus or a family history of corneal ectatic disease, said Dr Carones.

These patients are often recommended for surface ablation because of the higher risk of corneal ectasia associated with LAsiK procedures.

he noted that a 2008 study of 20 eyes of 10 patients with compromised corneas or a family history of keratoconus who were treated with simultaneous PRK and collagen crosslinking resulted in very good outcomes with 36 months’ follow-up.

“The precision of the procedure was not affected by the simultaneous crosslinking procedure at the time of the surgery and there was no loss in best corrected visual acuity for any of the patients,” he said.

Dr Carones also stressed the importance of targeting final corneal curvature that respects the safety limits.

“Corneal curvature is important because we do not want to flatten or steepen the cornea too much in order not to induce quality of vision problems and perhaps also tear film and epithelial irregularity which may lead to scarring in some cases,” he said.

Finally, Dr Carones emphasised the importance of respecting safety limits in terms of effective optical zone and patients’ scotopic pupil size to avoid any potential issues of haloes and night vision problems.

Francesco Carones – fcarones@carones.com

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REFRACTIVE LASER

Corneal curvature is important because we do not want to flatten or steepen the cornea too much in order not to induce quality of vision problems and perhaps also tear film and epithelial irregularity which may lead to scarring in some cases

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Francesco Carones MD

EUROTIMES | Volume 17 | Issue 7/8

improved surgical techniques and advances in laser technology and ablation profiles in recent years means that high myopia should

no longer be considered an automatic contraindication for LAsiK procedures, according to Jorge Alio MD, PhD.

“There is no doubt that LAsiK in high myopia is a challenge, but perhaps it is time to reconsider the real limits for safe treatments which have traditionally been set at around -8.0 D. The thinking was that the refractive outcomes beyond this limit are neither adequately predictable nor stable and also involved an increased risk of corneal ectasia. however, the reality is that we have no recent publications on this issue, and specifically no evidence that deals with the newest sixth-generation excimer lasers,” Dr Alio, chairman and director of the VissUM Ophthalmic institute in Alicante, spain, told delegates attending the World Ophthalmology Congress.

Furthermore, Dr Alio’s own clinical experience, including several studies looking at LAsiK outcomes in high myopia, suggest that the safety limit with today’s lasers may be closer to -12.0 D or -13.0 D than the current recommendation of -8.0 D.

“With the latest generation small beam flying spot lasers, LAsiK in high myopia seems to be a safe and predictable procedure. it does not induce significant aberrations and provides excellent quality of retinal image. in our practice, we currently prefer LAsiK to phakic iOLs in patients up to -13.0 D when the anatomic conditions are adequate,” he said.

While improvements in excimer laser technology have made it possible to consider treating high myopia with LAsiK for patients over -10 D, another factor to be borne in

mind is the lack of a fail-safe alternative to laser ablation, said Dr Alio.

“We have to remember that refractive intraocular surgery in high myopes is affected by more frequent and more severe complications than LAsiK. in refractive lens exchange, for instance, we have intraoperative complications such as vitreous loss in two per cent to four per cent of patients after conventional phacoemulsification, and retinal detachment also remains a known risk. For phakic iOLs, there are still issues with endothelial cell loss for anterior chamber iOLs, and pupillary block may be a problem in about one per cent of our posterior chamber iOL patients. Cataract can also be induced in about one per cent of these cases,” he said.

While LAsiK also suffers from intraoperative complications, many of these were associated with earlier generation lasers, said Dr Alio. “Problems such as the risk of ectasia and degraded quality of retinal image compared to phakic or pseudophakic iOLs are much less of an issue today,” he said.

For high myopia treatments, Dr Alio said that he uses the Amaris (schwind eye-tech-solutions) laser system, which offers a very high ablation speed with advanced eye tracking, rotation balance and cyclotorsion control. he also highlighted the ability of the laser to vary the fluence during the treatment, with higher energy applied in the first 80 per cent of the ablation to produce a faster treatment and lower energy in the last 20 per cent to ensure precise treatment with reduced speed.

“There is a large decrease in the ablation of tissue per dioptre by controlling energy delivery. We have the capability to control the thickness of the cornea intraoperatively via OCT to avoid surprises. We can also measure in real time the thickness of the stroma remaining after making the flap and the thickness of the stroma at the end of the treatment. Another advantage for high myopia treatments is the possibility to centre the treatment on the corneal vertex, which is a stable point in the optics of the eye, as well as the possibility to use large optical and transition zones,” he said.

Looking at the published data for LAsiK in high myopia, Dr Alio cited his own recent retrospective study of 51 eyes of 32 patients with high levels of myopia or myopic astigmatism treated using the schwind

Amaris and a femtosecond laser for flap creation.

That study showed high predictability, with 84 per cent of eyes within ±0.50 D of emmetropia and 90 per cent of eyes within 1.0 D. Efficacy was also impressive, said Dr Alio, with an average improvement of 15 LogMAR lines in uncorrected distance visual acuity three months after surgery. Best corrected distance visual acuity remained unchanged or improved in 98 per cent of eyes at three months postoperatively, with only one eye losing one logMAR line of corrected distance visual acuity.

Dr Alio noted that while the treatment did result in a limited but statistically significant induction of primary spherical aberration and coma, he said that the increase was still within acceptable limits and did not seem to impact on the patients’ quality of vision. he added that LAsiK enhancement was required during the follow-up period in only four eyes (7.8 per cent).

summing up, Dr Alio said that the new excimer lasers used in combination with the femtosecond laser for flap creation are pushing the limits of both myopic and hyperopic LAsiK without compromising safety.

Jorge Alio – jlalio@vissum.com

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HIGH MYOPIANew excimer lasers push the limits for high myopia treatmentsby Dermot McGrath in Abu Dhabi

9Special Focus

REFRACTIVE LASER

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With the latest generation small beam flying spot lasers, LASIK in high myopia seems to be a safe and predictable procedure

“

Jorge Alio MD, PhD

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EUROTIMES | Volume 17 | Issue 7/8

The use of improved aspheric ablation profiles and larger optical zones means that LAsiK can now be proposed as a safe and

predictable method to correct hyperopia in patients with or without astigmatism up to 6.0 D, reports Diego de Ortueta MD, FEBO.

“Up to around 2004 the recommendation was that patients with greater than 4.0 D of hyperopia should not be treated with LAsiK due to problems of regression and induced aberrations. since then the situation has evolved considerably thanks to the latest aspheric ablation profiles and optical zones in the range of 6.5mm which take the

preoperative K reading into account. Better centration techniques using iris recognition and pupil centroid shift compensation have played a part in improving outcomes,” he said.

Dr de Ortueta, in private practice at the Aurelios Augenzentrum, Recklinghausen, Germany, told delegates attending the World Ophthalmology Congress that the broad goal of hyperopic LAsiK is to increase the curvature of the cornea without inducing aberrations and ensuring that the change remains stable over time.

he noted that regression was one of the main problems associated with first-

generation hyperopic LAsiK treatments, but is far less of an issue today.

“This was often due to paracentral epithelial hyperplasia during wound healing or fibrosis and was associated with the use of small optical zones. The recommendation now is to use an optical zone of 6.5mm in order to cover the mesopic pupil, and with smoother transition zones, as an abrupt step may cause compensatory healing responses after surgery and lead to regression,” he said.

The improved stability of hyperopic LAsiK treatments using larger optical zones and improved ablation profiles is reflected in the scientific literature, said Dr de Ortueta. he cited a study by Kezirian et al in 2008 that looked at the long-term outcomes of 127 patients treated for up to 6.0 D of hyperopia with the Allegretto Wave (Alcon).

“The four-year results with the Allegretto Wave for hyperopia showed stability of the manifest refraction spherical equivalent within 1.00 D in 94 per cent of eyes. Regression of effect of more than 1.0 D was seen in just six out of 127 eyes or 4.7 per cent and progression of effect was seen in two out

of 127 or 1.6 per cent,” he said.Another study by Waring et al. in 2008

looking at hyperopic LAsiK with the NiDEK EC-5000 excimer laser also showed impressive stability in 293 eyes up to six months postoperatively, said Dr de Ortueta.

Furthermore, Dr de Ortueta’s own results in 2010 of 66 consecutive eyes of 37 patients treated for hyperopic astigmatism with the schwind Esiris excimer laser showed that postoperatively 92 per cent of eyes were within 0.50 D after three months, 83 per cent after 12 months, and 72 per cent after 36 months.

in order to reduce induced aberrations associated with hyperopic LAsiK, Dr de Ortueta said it was important to ensure that the ablation centre is shifted to the cornea vertex normal rather than the traditional pupil centre.

summing up, Dr de Ortueta said that the latest aspheric ablation profiles generated by optimised algorithms, allied to better registration and centration techniques, are all helping to deliver more precise and effective results.

Diego de Ortueta – ortueta@gmx.de

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HYPEROPIC LASIKAspheric ablation profiles are helping to deliver more precise and effective resultsby Dermot McGrath in Abu Dhabi

10

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REFRACTIVE LASER

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Sunday, 9 SeptemberNew Value Proposition in Cataract and Refractive Surgery: Femtosecond Laser and Advanced Technology IOLsSpace 1 – Milan Conference Centre

13:00 - 14:00 (lunch boxes will be provided)Moderator: Dr. Robert Cionni, USAFaculty: Dr. Philippe Crozafon, France Dr. Kjell G. Gundersen, Norway Prof. Dr. Michael C. Knorz, Germany Prof. John Kanellopoulos, Greece

Discover what’s new in cataract-refractive surgery featuring femtosecond laser cataract surgery using the LenSx® Laser as well as the AcrySof® IQ ReSTOR® family of Multifocal and Multifocal Toric IOLs.

Sunday, 9 SeptemberAdvancements in the Diagnosis and Treatment of Dry EyeSpace 3 – Milan Conference Centre

13:00 - 14:00 (lunch boxes will be provided)Moderator: Dr. James P. McCulley, USAFaculty: Dr. Stephen S. Lane, USA Dr. Stefano Barabino, Italy

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Sunday, 9 SeptemberInnovations in Cataract and Refractive SurgeryAuditorium di Milano

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EUROTIMES™

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EUROTIMES | Volume 17 | Issue 7/8

Modern LAsiK technologies and techniques and more advanced lens technologies are leading to increased options and better

outcomes for patients with higher degrees of myopia. Experts debated the merits of each approach at the XXXV UKisCRs Congress.

Advocating LAsiK as the best option for this cohort, Dan Reinstein MD, MA(Cantab) FRCsC, FRCOphth, DABO, FEBO, medical director of the London Vision Clinic, highlighted the risks and invasiveness of refractive lens exchange (RLE), particularly its effect on accommodation while demonstrating the relative increased safety and efficacy of LAsiK.

he listed the potential serious complications of RLE, such as macular oedema, endophthalmitis, suprachoroidal haemorrhage and retinal detachment. The latter is much higher in high myopic clear lens exchange than it is in cataract surgery. in addition, when multifocal iOLs are not tolerated following RLE it often leads to iOL explantation and exchange procedures that are highly risky, and all this when a micro-monovision extraocular procedure would have done the job, he said.

“so this is the scenario that we’re talking about when going inside the eye to do an elective procedure for someone that can already see albeit with glasses. This level of risk needs to be explained to the patient in the context of the elective nature of the procedure,” Prof Reinstein contended.

he pointed out that the literature has plenty of studies for high myopic clear lens exchange in the early 1990s but less as time went on. This implied the reluctance in the

ophthalmic community to continue to offer RLE and publish results, he suggested.

On the other hand, high myopic LAsiK was curbed at the time because of induced night vision problems as well as the increased risk of ectasia, and a number of studies found better results with phakic iOLs than LAsiK. however, Prof Reinstein noted this was because the excimer machines used in the published comparison studies were older and less advanced - ie, were using only primitive ablation profiles without modern spherical aberration compensation compared to what is now currently available.

“Further studies have come out since then but they are still comparing older technologies and not modern excimer lasers and modern laser excimer ablation profiles,” he added.

The question of spherical aberration increasing after myopic ablations was described in detail by Prof Reinstein, who demonstrated his research using the Artemis VhF digital ultrasound scanner in which he shows that the majority (about 85 per cent)of spherical aberration actually comes from biomechanical corneal changes – primarily, the fact that the stroma actually thickens in the periphery outside the ablation zone. While spherical aberration pre-compensation can help, if it is excessive it can lead to central islands, he cautioned.

Prof Reinstein believes there is a lot of confusion in the profession about the current capabilities of high myopia corneal surgery because people are made to think all technologies are the same by certain manufacturers.

“What we have developed as forefront technology in controlling the induction of night vision problems is way superior to what is currently called 'wavefront-guided' or 'wavefront-optimised' surgery – which by the way, are actually similar although certain manufacturers claim they are different. it is not going to be long now before the three superior excimer lasers are also doing this and further down the road before all excimer lasers will be copying it,” he told EuroTimes.

he also promoted the merits of two stage procedures and said it is known now that topography-guided treatments work far better than wavefront-guided treatments in reducing spherical aberration, increasing contrast sensitivity and reducing night vision disturbances.

Addressing the risk of ectasia, Prof Reinstein said keratoconus screening has improved significantly as have surgical techniques in the last decade.

“Our ability to pick up sub-clinical keratoconus is much better than it used to be and our ability to not inadvertently go too deep within the cornea by creating very thin flaps – 80 microns with the Carl Zeiss Meditec VisuMax femtosecond laser – means our chances of producing ectasia have gone from very low to exceedingly low,” he elaborated.

Concluding his arguments, Prof Reinstein maintained that moderate to high myopia is best treated by thin flap LAsiK and he also favoured partial correction for even higher myopia over the risks of refractive lens exchange.

RLE has its benefits in contrast, Rajesh Aggarwal FRCs, FRCOphth, southend University hospital, Essex, promoted RLE as the better option for moderate to high myopia.

he reminded delegates of the problems of glare and night vision in some LAsiK patients and the difficulties associated with LAsiK in patients with thin corneas. Both of these issues were more likely when treating patients with a higher degree of myopia.

LAsiK also does not address the problem of presbyopia nor the potential for cataracts, he noted.

“And the refractive error after LAsiK is not stable because although the corneal refraction may be stable, you still get lenticular changes as the patient gets older, and patients will also develop cataracts as they get older,” Dr Aggarwal pointed out.

Phakic iOLs with improved lens design have come back in favour and do have the advantage of being reversible, but still have risks. These include endothelial cell loss, resulting in bullous keratopathy, glaucoma, cataract formation, iritis and pupil ovalisation.

“so if we look at clear lens exchange as an alternative it has many advantages. With newer technology surgeons have lots of options including monovision, using refractive multifocals, diffractive multifocals and sectorial multifocal iOLs. You can also use a combination of these. We also have newer technologies in accommodative lenses which almost certainly is where the future lies,” Dr Aggarwal commented.

The advantages of clear lens exchange are obvious, he said. it is a very familiar procedure for surgeons; it is very rapid, predictable and gives a very stable outcome. The optics now are excellent and in future there will be customised aberration correction, he continued, adding that cornea thickness is not an issue with clear lens exchange.

Another advantage is that clear lens exchange addresses presbyopia and there is no regression due to age-related lenticular change. hence a second procedure later in life is avoided.

however, he did note that clear lens extraction was not without risk. This included the risk of retinal detachment which is between zero and eight per cent for clear lens exchange compared to two to four per cent following cataract surgery.

Acknowledging that LAsiK can be a better option for younger patients, Dr Aggarwal concluded that clear lens exchange remains the better option for older patients and those with higher myopia. Moreover, as designs for iOLs improve, younger patients are more likely to opt for clear lens exchange.

Dan Reinstein – dzr@londonvisionclinic.comRajesh Aggarwal – rajesh@r-aggarwal.co.uk

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LASER OR LENS?Debating the best choice for high myopiaby Priscilla Lynch in Southport

12 Update

CATARACT & REFRACTIVE

With newer technology surgeons have lots of options including monovision, using refractive multifocals, diffractive multifocals and sectorial multifocal IOLs. You can also use a combination of these

“

Rajesh Aggarwal FRCS, FRCOphth

Further studies have come out since then but they are still comparing older technologies and not modern excimer lasers and modern laser excimer ablation profiles

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Dan Reinstein MD, MA(Cantab) FRCSC, FRCOphth, DABO, FEBO

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EUROTIMES | Volume 17 | Issue 7/8

Pre-fragmenting cataractous lenses with a femtosecond laser before phacoemulsification appears to produce less endothelial cell loss at

six months compared with eyes treated with conventional phaco only, Mark Packer MD, FACs, CPi, Eugene, Oregon, Us, told the American Academy of Ophthalmology.

he discussed an ongoing prospective contralateral eye study that involved 309 femto-laser treated eyes and 123 conventionally treated control eyes. Dr Packer noted that endothelial cell loss is widely recognised as a barometer of ocular health after anterior segment surgery.

“We were looking at safety, not efficacy, and in terms of safety i think we are doing quite well with this new technology.”

Reduced phaco energy in theory, reducing the amount of phaco energy and fluid volume required for lens removal using femto pre-fragmenting could result in less disruption during surgery, leading to less corneal oedema, anterior chamber cells and flare one day after surgery, as well as reduced long-term loss of endothelial cell density attributable to surgery. in other studies, reductions in phaco energy ranging from 40 per cent to 100 per cent, depending on cataract grade, have been documented.

in this study, harvey Uy MD, Manila, Philippines, examined the hypothesis by using a LensAR femtosecond laser to pre-fragment lenses in test eyes while using conventional phaco only in the contralateral eye when indicated. Dr Uy performed all the procedures using standardised technique and phaco settings on an Alcon infinity system with OZil, and implanted Acrysof sA60 AT intraocular lenses in all eyes.

Endothelial cell count was measured at baseline and three and six months after surgery using an automated Konan CellCheck XL. While this device does lead to some variation in cell counts, Dr Packer said that it is adequate for technology assessment when used on a sample size large enough for statistical analysis of standard deviations.

At three months, overall outcomes were not statistically significant between the two groups, Dr Packer reported. in 225 eyes treated with femto pre-fragmentation, endothelial cell loss averaged 0.7 per cent, compared with a gain of 0.1 per cent for 63 eyes treated with conventional phaco (p=0.16) (see figure). Broken down by cataract grade, the femto-treated group had less endothelial cell loss that was statistically significant at 90 per cent for grades 1 and 3, but no significant differences were seen for grades 2 and 4.

“What is most striking is the very small degree of endothelial cell loss in either group. it was essentially zero in the phaco group. By comparison published studies show about six to seven per cent and 10 to 11 per cent in complicated eyes. so to see one per cent is quite an achievement. My hat is off to Dr Uy,” Dr Packer noted.

At six months, 309 femto-treated eyes averaged a loss of 0.4 per cent compared with 123 phaco-only eyes averaging a 2.6 per cent loss, a result that was significant at the 90 per cent level. Only grade 1 eyes showed a significant difference at six months. Dr Packer speculated that the difference in outcomes between the two groups might be greater for surgeons with more typical endothelial cell loss ratios than Dr Uy’s. Data collection and analysis are ongoing to further strengthen the statistical model.

LESS CELL LOSSPre-fragmenting lens shows slightly less endothelial cell loss at six monthsby Howard Larkin in Orlando

Mark Packer – mpacker@finemd.comcontactad-EUR-1-2 hoch-1202v2-pva RZ.indd 1 29.02.12 13:43

Update

CATARACT & REFRACTIVE

The table shows the ECD data For the 225 laser cases mean loss in cellCo

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EUROTIMES | Volume 17 | Issue 7/8

The Catalys™ Precision Laser system (OptiMedica), a next generation femtosecond laser system optimised for cataract surgery,

performs anterior capsulotomies with greater precision than that achieved manually by experienced surgeons and all but eliminates the need for ultrasound during lens emulsification and removal, said h Burkhard Dick MD, PhD, Ruhr University Eye Clinic, Bochum, Germany.

“The improvements in precision made possible by the Catalys system are truly remarkable and represent a significant advancement in the practice of modern cataract surgery,” Prof Dick said at the 16th EsCRs Winter Meeting.

he noted that he first began working with the Catalys system in December of last year and since that time has used it in over 140 cataract procedures. To illustrate the potential benefits that the system can provide to cataract surgeons and their patients, Prof Dick presented the results achieved in 57 eyes of patients who underwent femtosecond laser-assisted cataract surgery and compared them with those he achieved in 52 eyes of patients who underwent standard phacoemulsification with manually performed capsulorhexes.

The patients in both the femtosecond laser-assisted and standard phacoemulsification groups had cataracts ranging from LOCs grade one to grade four in density. Those in the femtosecond group had a slightly higher LOCs grade with mean nuclear density 3.4. in all eyes in the femtosecond-laser treated group Prof Dick used the same femtosecond laser settings in terms of laser fragmentation pattern, pulse energy, grid spacing and spot separation. he also used the stellaris phacoemulsification system (Bausch + Lomb) with a coaxial technique in all eyes.

Accurate and safe Prof Dick noted that examination of the removed capsule tissue showed that capsulotomies created with the laser deviated from their target diameter by a mean of only 29.0 microns. That compared to a mean deviation from target diameter of 339.0 microns in the manually created capsulorhexes. in addition, the mean circularity of the capsulotomies, where 1.0 represents a perfect circle, was 0.936 in the femtosecond group, compared to 0.774 in the manual group.

Moreover, eyes undergoing cataract surgery with the Catalys system required only a minimal amount of effective phaco time in even the hardest cataracts. The mean effective phaco time was only 0.16 seconds in 57 eyes that underwent phaco-fragmentation with the femtosecond laser, compared to 4.07 seconds in 52 eyes that underwent standard phacoemulsification, representing a 96 per cent reduction in phaco time.

Furthermore, the amount of effective phaco time required in eyes with LOCs grade ii, iii, iV cataracts was only 0.02 seconds, 0.16 seconds, and 0.25 respectively in eyes treated with femtosecond laser. That

compared to phaco time requirements of 1.29 seconds, 1.96 seconds, and 3.32 seconds in the conventional phacoemulsification group, respectively, for the same grades of cataract.

“The exposure to ultrasound has been minimised or eliminated, with 74 per cent of the cases requiring 0.25 seconds or less and 31 cases using zero seconds. The Catalys technology i believe may enable cataract removal via aspiration through a 1.2mm incision. if consistently demonstrated, this result will create need for new iOLs that will fit through these incisions,” he added.

in regards to safety, Prof Dick said that there were no capsular tears or vitreous

loss or other iatrogenic complications in any eyes. Eyes treated with Catalys had corneas that were extremely clear from the immediate postoperative onward. Moreover, the conjunctiva remained unaltered, even in patients receiving anticoagulant therapy due to minimal iOP rise induced by Liquid Optics™ suction ring. in the femtosecond group,the iOL positioning was perfect with all types of iOLs used including toric and accommodative iOLs, he added.

Catalys: key technologies Prof Dick noted that the Catalys Precision Laser system combines an ultra-rapid femtosecond laser, integrated optical coherence tomography imaging, and specific pattern scanning technology. Furthermore, the Liquid Optics™ interface fills in corneal surface irregularities with liquid and thereby optimises the optical path for visualisation and the delivery of laser energy to the patient’s eye, he said.

“When you apply the suction ring to the eye, the intraocular pressure rise is low. The mean iOP increase we measured was 10 mmhg. And because it is a fluid-filled interface, the cornea is not applanated,” he noted.

The Catalys system provides visualisation of the ocular surfaces, from the corneal surface into the vitreous, using an integrated infrared camera and three-dimensional spectral domain OCT imaging technology, Prof Dick said. The system also has built in algorithms that detect and map in 3D relevant ocular surfaces to customise treatment plan with a well-defined safety zone.

Once the surgeon has confirmed the treatment plan on the OCT images, the treatment proceeds with the capsulotomy and phaco-fragmentation. The capsulotomy takes a few seconds to complete and phaco-fragmentation time is dependent on a number of factors such as pattern chosen, grid spacing and pupil dilation. The entire procedure time (from suction on to suction off at completion of cuts) had mean of two and a half minutes, the maximum time was three and a half minutes and the fastest was one and a half minutes.

summarising his experience in his first 140 cataract cases with the Catalys system, Prof Dick said that it improved the precision of sizing the capsulotomy compared with manual technique. The system also demonstrated a significant improvement in precision of capsulotomy size and shape. The use of the laser also resulted in a considerable reduction in ultrasound energy use during phacoemulsification.

“The next goal will be to eliminate ultrasound phaco totally by modifying the instruments and the vacuum settings and laser settings. i'm very confident that femtosecond cataract surgery will become an integral part of our surgical options,” he concluded.

H Burkhard Dick – dickburkhard@aol.com

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OPTIMISED LASER SYSTEMNew system improves the precision of sizing the capsulotomy compared with manual techniqueby Roibeard O’hEineachain in Prague

14 Update

CATARACT & REFRACTIVE

Catalys™ Precision Laser System, OptiMedica Corporation (Sunnyvale, CA)

Manual capsulorhexes (above) and Catalys capsulotomies (below) stained with Trypan Blue. Catalys capsulotomies exhibit

precision in size and shape from case to case

Comparison of effective phaco time used per case for eyes that received Catalys lens fragmentation vs. eyes that did not receive Catalys laser lens fragmentation

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EUROTIMES | Volume 17 | Issue 7/8

Rigorous hygiene practices are vital in the quest to prevent the occurrence of endophthalmitis following cataract surgery, the

UKisCRs XXXV Congress meeting heard.Christopher Liu FRCOphth, consultant

ophthalmic surgeon, sussex Eye hospital, told delegates that prevention is better than cure and there are a number of key precautionary measures that can be taken to minimise endophthalmitis risk factors.

Dr Liu emphasised the importance of absolute cleanliness at all times, starting with the surgeon himself, to the scrub nurse, to the theatre, to the instruments, the patient and their follow-up carers.

“For the surgeon the first scrub is meant to be five minutes. Povidone-iodine 10 per cent detergent would be a good agent. Keep your nails short and clean and always assume that the gloves have perforations, even when you put them on, as there is a perforation rate that is allowed for glove manufacturers. Try not to touch the tips of the instruments and make sure when you wear your facemask that your nose and chin are covered and try to avoid talking as much as possible. if you sneeze, don’t turn to one side, step back and sneeze forward. Excessive movements should also be avoided,” Dr Liu advised.

“it is also really important that instruments are cleaned before sterilisation otherwise the proteins and so on will simply be baked onto the instruments,” he noted, adding that air quality is another important aspect of hygiene control.

Safest option Discussing wound considerations, he suggested that a scleral tunnel is the safest option, “though it is not practised much anymore so it’s down to your corneal wounds, which leak more frequently”.

he said if surgeons use a longer wound it is likely to be more secure, especially if they do not stretch it. “With hard nuclei beware of burning the wound with a phaco burn as well,” he cautioned.

Dr Liu said if surgeons use a temporal wound they might consider asking the patient to wear a shield continuously for the first few days. if using sub-conjunctival injection make sure it is kept away from the wound, he stressed.

“Whenever you are in doubt if there is a

leaky wound then put a suture in, that helps a lot.”

When finishing up surgery, Dr Liu recommended using povidone iodine post-drape if the tear film looks dirty. he also advocated pulling instruments out gently and coming out of position slowly whilst irrigating so as to avoid creating an unwanted vacuum drawing extraocular fluids into the eye. he also advised removing the speculum carefully without pressing on the eye, and removing the drape in a sterile fashion.

Antibiotic ointment should be applied to the lid margins if there is still some blepharitis postoperatively. Moreover, contact lens wearers should remove them a day or two beforehand.

summarising his prevention strategies, Dr Liu said surgeons should keep their operations short and free from unnecessary complications, and use subconjunctival or intracameral cefuroxime. some patients may benefit from preoperative antibiotics. Finally, pay close attention to wound architecture and wound protection and place a suture if in doubt, and use an eye shield for temporal wounds.

ENDOPHTHALMITISReduce risk with attention to basic techniquesby Priscilla Lynch in Southport

Christopher Liu – CSCLiu@aol.com

contact

Povidone-iodine 10 per cent detergent would be a good agent. Keep your nails short and clean and always assume that the gloves have perforations, even when you put them on, as there is a perforation rate that is allowed for glove manufacturers

“

Christopher Liu FRCOphth

Update

CATARACT & REFRACTIVE

16

EUROTIMES | Volume 17 | Issue 7/8

Phakic iOL candidates require a comprehensive workup to rule out any potential anatomic or physiological problems, Jan Venter MD, London, told delegates attending the XXXV UKisCRs

Congress.When patients attend for screening, his clinic first

looks at corneal topography (Pentacam, Oculus) and measures anterior chamber depth, which is critical in these patients, and screens for corneal diseases and keratoconus. “About five to 10 per cent of these patients need a laser enhancement so we need to know the cornea topography is normal to allow us to do this and also we identify the steepest meridian of the cornea where we place our incision for a non-toric or even a toric lens,” he said.

The biometry of the patient is checked for future reference and it confirms the anterior chamber depth. The white-to-white measurement is also taken as that is necessary for the use of an Acrysof Cachet lens as well as for the Visian iCL lens calculation of size. Autorefraction is also used, as a reference for manifest refraction, while tonometry is used to exclude any ocular hypertension or glaucoma, which he said are considered as contraindications for a phakic iOL.

Especially important is the specular microscopy findings in these patients, he said. “As we know we have about 4,000 cells/mm2 in the first decade of life but we lose about 0.6 per cent every year and at 40 years of age we have about 2,600 cells/mm2,” Dr Venter said.

The patients’ cell density is thus carefully examined by the clinic. With polymegathism, the difference in sizes across cells in the area is measured with a lower CV more desirable, while looking at pleomorphism (percentage of cells with six sided architecture – ie, hexagonal), a higher percentage is desirable for a phakic iOL.

“We exclude patients with endothelial cell problems, guttata, Fuchs, etc. Currently we would want a cell count of more than 3,000 cells/mm2 if patients are younger than 30 years of age and for patients over 30 we would want 2,000 cells/mm2 or more for Artisan/Artiflex. For an Acrysof Cachet and Visian iCL, we use the FDA guidelines. Part of the informed consent forms that they sign states that they attend for a yearly endothelial cell count,” he said.

Emphasising the importance of cell loss, he outlined the findings of a number of studies. Looking at a European multicentre study (Budo, 2000) on iris fixated lenses, there was about a nine per cent loss over a period of three years, while looking at the results of a study (henry F Edelhauser) on posterior chamber iOLs there was a cell loss of 12.5 per cent over a period of five years. “if you ask why, as the lens is behind the pupil, it is generally because of chronic inflammation. The lens rests on the iris, the lens fixates on the ciliary body and that causes chronic inflammation which contributes to cell loss even with a posterior chamber lens,” he explained.

Returning to his clinic’s screening procedures, Dr Venter said they also use optical coherence tomography (OCT) to look at the anterior chamber depth from the endothelium

(requiring a minimum of 2.8mm), the iris configuration, the true angle to angle distance, and the crystalline lens rise (maximum 0.6mm), which is the measurement of the distance between the anterior surface of the crystalline lens and the horizontal line between the two angle recesses.

Lens rise limit Elaborating the rationale behind the lens rise limit, he said the lens rise increases by 20 microns each year and it is possible to calculate the number of years a lens can stay safely in the eye before reaching maximum lens rise (Baikoff G. et al. Pigment dispersion and Artisan phakic intraocular lenses: Crystalline lens rise as a safety criterion. J Cataract Refract Surg 2005; 31:674-680).

“Thus, if it exceeds 0.6mm (600 microns), the patient is not suitable for a phakic iOL, particularly an Artisan Artiflex lens, as 60 per cent of these people will develop posterior synechiae and you will end up having to remove the lens, so we critically look at that,” he noted.

Meanwhile, Dr Venter said new software for OCT allows the clinic to simulate the position of the lens prior to the surgery, which helps determine its safety in the distance of the phakic iOL from the epithelium, and the vaulting through the distance of the phakic iOL from the crystalline lens. A safe distance is 1.5mm at the edge of the phakic iOL and 2.0mm at the centre of the lens, he told delegates, adding that surgeons must remember the crystalline lens grows by 20 microns per year so the distance between it and the phakic iOL will reduce over time.

Dr Venter’s clinic also measures the scotopic pupil size, by Colvard or Wavefront aberrometer, in these patients. Glare and haloes are seen in patients with big pupils so the maximum pupil size is 6.5mm for an Artisan 5.0mm lens, and 7.0mm is the maximum pupil size for an Artisan 6.0mm lens, while there is no restriction for the Visian iCL lens.

A retinal OCT is also performed on these patients to document any retinal pathology, myopic degeneration, etc, and exclude any active pathology. And of course manifest refraction is very important to confirm refraction stability, he stressed. Finally, Dr Venter himself then sees the patients for a dilated fundus examination and slit lamp examination before the final decision on the patient’s suitability for the procedure is made.

contact

PHAKIC IOL Screening is important when reaching decisions on phakic IOL candidatesby Priscilla Lynch in Southport

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Update

CATARACT & REFRACTIVE

Jan Venter – janventer@opticalexpress.com

Currently we would want a cell count of more than 3,000 cells/mm2 if patients are younger than 30 years of age and for patients over 30 we would want 2,000 cells/mm2 or more for Artisan/Artiflex

“Jan Venter MD

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18

EUROTIMES | Volume 17 | Issue 7/8

Goldmann applanation tonometry does not overestimate intraocular pressure (iOP) following

manual Descemet stripping endothelial keratoplasty (DsEK), as might be expected given much thicker central corneas after surgery, reported Dipanjan Pal MBBs of Priyamvada Birla Aravind Eye hospital, Kolkata, india, at the 2011 annual meeting of the AAO. Contrary to studies in normal eyes, Goldmann measures of post-DsEK eyes in a recent study did not correlate with central corneal thickness, he noted.

however, differences between mean iOP measured by dynamic contour tonometry (DCT)and Goldmann in post-surgery eyes were similar to those in a normal control group, with DCT readings running a little over 2.0 mmhg higher than Goldmann readings in both groups. These results suggest that Goldmann may be suitable for monitoring pressure after DsEK. however, results from the two methods were not comparable, and Dr Pal recommended that they should not be used interchangeably.

Goldmann vs DCT DsEK involves selective replacement of damaged corneal endothelium, and typically results in increased corneal thickness. Goldmann tonometry, which calculates iOP based on the pressure required to applanate the cornea based on a modified imbert-Fick law, has been shown to depend on central corneal thickness. Correction factors may be needed for accurate iOP readings with thicker corneas. DCT is a novel technique that is less influenced by central thickness and curvature of the cornea. Dr Pal’s purpose was to compare their performance in DsEK and normal eyes from the same patient cohort.

in a case control study conducted between March 2009 and November 2010, Dr Pal and colleagues compared Goldmann and DCT readings between eyes that had undergone manual DsEK and normal eyes in the same patient cohort. DsEK group inclusion criteria included clear cornea and post-op status at least three months after surgery. Eyes treated with anti-glaucoma medication, eyes that had ocular surgeries other than cataract extraction, eyes with ocular trauma, eyes with more than 3.0 D astigmatism, eyes with poor visual

outcomes and eyes with poor quality scores on DCT were excluded.

A total of 46 DsEK eyes in 42 patients qualified. These were compared with 35 non-DsEK eyes in 35 patients, with one-eyed patients and those with corneal oedema excluded. All patients were Asian indians with mean age of 60.2 years. Measurements were conducted at a mean 10.15 months after surgery. indications for DsEK were bullous keratopathy for 33, Fuchs’ endothelial dystrophy for 12 and iridocorneal endothelial syndrome for one. For each patient three Goldmann and three acceptable quality DCT scores were averaged and compared. Central corneal thickness results were also averaged from three measurements.

in the DsEK group, mean Goldmann iOP measured 19.40 mmhg, or a mean 2.12 mmhg less than the DCT mean of 21.50 mmhg (p<0.0001), and mean central corneal thickness was 624.5 microns. Mean Goldmann iOP value in the unoperated control group 15.12 mmhg, or a mean 2.36 mmhg less than the 17.60 mmhg DCT mean (p<0.05), and mean central corneal thickness was 518.41 microns. The higher mean readings for DCT is consistent with previous published reports, Dr Pal noted. Various studies have found that DCT measures were higher than Goldmann by a mean of 0.4 to 7.7 mmhg. (Doyle A et al. J Glaucoma 2005; 14:288-92; Schneider E et al. J Glaucoma 2006; 15:2-6).

interestingly, iOP universally measured higher in DsEK eyes by both the methods.

Analysis showed a strong positive linear correlation between Goldmann and DCT iOP measurements in both DsEK (r=0.935; p<0.0001) and controls (r=0.882; p<0.0001). however, while previous studies have found an inverse correlation between central corneal thickness and Goldmann iOP readings for normal eyes, as did this one, this study found no significant correlation between Goldmann or DCT iOP and corneal thickness in DsEK eyes.

Both Goldmann and DCT showed higher mean iOP values in DsEK eyes, and the differences were independent of central corneal thickness, Dr Pal concluded.

Dipanjan Pal – dpal@birlaeye.com

contact

TONOMETRYGoldmann not affected by thicker corneas, but dynamic contour differences persistby Howard Larkin in Orlando

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Update

CORNEA

EUROTIMES | Volume 17 | Issue 7/8

Recurring corneal melts in patients with rheumatoid disease may respond best to aggressive therapy which can include biologic modalities such as infliximab, an inhibitor of tumour necrosis

factor-alpha (TNFα), according to a case study presented by Dipak Parmar FRCOphth, FRANZCO, London, UK, at the Cornea Day session at the 16th EsCRs Winter Meeting.

The patient was a 47-year-old sri Lankan man who initially presented in October 2006 with a corneal perforation in his right eye with 80 per cent corneal thinning and 20 per cent corneal thinning in his left eye, Dr Parmar noted. his visual acuity was 6/19 in his right eye and 6/9.5 in his left eye. Both eyes had a peripheral inferonosal gutter at 3 to 6 o’clock.

The patient’s medical history included rheumatoid arthritis of five years’ duration which was systemically quiescent and managed under a rheumatologist at another hospital. his current regimen included prednisolone 4mg per day and methotrexate 7.5mg per week, together with calcium carbonate, alendronic acid and diclofenac.

Dr Parmar initially treated him with corneal glue repair and increased the prednisolone dosage to 60mg per day (plus ranitidine) and gradually increased his methotrexate dosage to 20mg per week over the next three months.

in February 2007 the patient had a repeat corneal perforation in his right eye. Dr Parmar again treated the eye with corneal glue repair together with multilayered amniotic membrane transplantation and Parasol punctual plugs (Odyssey) in both eyes. The patient also received a low dosage of methotrexate, 2.5mg per week, and his condition remained stable for a year at which point he was lost to follow-up.

Two years later he returned to the clinic with corneal perforations in both eyes (Figure 1). Dr Parmar performed bilateral simultaneous tectonic penetrating keratoplasties and increased his methotrexate dosage to 10mg per week and prednisolone to 60mg per day.

however, just one month after the penetrating keratoplasties there was a repeat corneal perforation in the patient’s right eye. he underwent corneal glue repair on three further occasions and had his methotrexate dosage increased to 25mg per week. he also received topical cyclosporine 0.05 per cent (Restasis) twice a day in both eyes.

in July 2009 the patient underwent repeat penetrating keratoplasty with amniotic membrane graft overlay in his right eye. however, the graft was not successful and he required yet another penetrating keratoplasty within a week. in addition, the graft in the patient’s other eye developed paracentral thinning, which continued unabated despite the application of a multilayered amniotic membrane graft, high-dose methotrexate and corneal glue repair.

Unfortunately the patient had developed adverse reactions to azathioprine and cyclophosphamide, which meant that there were very few treatment options left. At this point infliximab was suggested as a treatment option to Dr Parmar by his rheumatologist colleague. infliximab is an anti-TNFα chimaeric monoclonal antibody that prevents TNFα binding to cellular receptors and induces apoptosis in TNFα-expressing activated T-cells.

immediately after undergoing a repeat tectonic graft in his left eye, the patient commenced intravenous therapy with infliximab administered every six weeks. At 30 months post infliximab both corneas were stabilised, with no evidence of disease progression (Figure 2). his best corrected visual acuity was 6/48 in the right eye and 6/36 in the left, limited by pre-existing corneal subepithelial haze.

Dr Parmar concluded: “i would definitely encourage those of you managing patients with corneal melts secondary to rheumatoid or other inflammatory conditions to consider these biological agents.”

Dipak Parmar – parmar321@gmail.com

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CORNEAL MELTSBiologic agent Infliximab proved effective when all else failedby Roibeard O’hEineachain in Prague

19

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Figure 1: Bilateral inferonasal crescent-shaped corneal thinning with perforation and iris prolapse, June 2009

Figure 2. Right and left eyes after repeated penetrating keratoplasty and cataract extraction with intraocular lens implant, January 2012

I would definitely encourage those of you managing patients with corneal melts secondary to rheumatoid or other inflammatory conditions to consider these biological agents

“Dipak Parmar FRCOphth, FRANZCO

Update

CORNEA

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20

EUROTIMES | Volume 17 | Issue 7/8

Recent insights into molecular and cellular pathways of tear dysfunction are leading to new therapies for superficial epithelial

corneal disease, one of the most common problems treated by ophthalmologists, stephen C Pflugfelder MD of Baylor College of Medicine, houston, Texas, Us, told the American Academy of Ophthalmology in the 67th Edward Jackson Memorial Lecture.

With symptoms including severe dry eye, pain, photophobia and blurred vision, superficial epithelial corneal disease can be as disabling as unstable angina, making it a significant threat to health and well-being. several recently developed treatments targeting tear dysfunction can often prevent or reverse these symptoms and the related corneal disease, and more treatments are in development, Dr Pflugfelder said. The cornea accounts for 65 per cent of the optical power of the eye, but is also the most exposed mucosal surface in the body, open 92 per cent of the time during waking hours, Dr Pflugfelder noted. Replenished about 15 times per minute by blinking, tears play several essential roles in both maintaining visual quality and corneal health.

Precorneal tear gel improves vision by masking light scattering due to irregular microplicae on the superficial corneal epithelium, Dr Pflugfelder said. Tears also maintain corneal homeostasis, supplying the avascular cornea with essential factors for defending against microbial attachment, suppressing corneal inflammation and degradation and promoting rapid wound healing. At the same time, tears protect the cornea from environmental, recreational and occupational desiccating stress. But they are not always up to the task, Dr Pflugfelder said. “Unfortunately, dry eye is an unavoidable complication of certain professions.”

Risk factors for tear dysfunction include diabetes mellitus, low dietary intake of omega n-3 and n-6 essential unsaturated fatty acids, prolonged computer or video use, chronic exposure to low humidity, chronic contact lens wear and LAsiK. Tear dysfunction has been recognised for more than 100 years as the most common cause of superficial corneal disease, and addressing it is often the key to treating corneal surface conditions.

Lacrimal functional unit Tear secretion is regulated by the lacrimal functional unit, which consists of sensory nerves in the cornea and conjunctiva communicating with the organs that produce tear components. The precorneal tear film that protects and nourishes the cornea is a mixture of growth factors, cytokines, antimicrobial peptides, immunoglobins and protease inhibitors secreted by the lacrimal glands. Mucins that lubricate and smooth the corneal surface are produced by epithelial membranes and conjunctival goblet cells. The tear layer is topped by lipids that reduce evaporation produced mainly by the meibomian glands.

When working properly together, the components of the lacrimal functional unit create a balanced tear film that supports corneal health and normal function. however, disruption of the signalling or disease of one or more of these components result in changes in tear composition that in turn promote a variety of pathological changes in corneal epithelial cells, Dr Pflugfelder said. “Tear dysfunction activates stress signalling in the corneal epithelium.”

severe dry eye can be treated with the PROsE contact lens device that keeps the eye surface hydrated, Dr Pflugfelder added. “it shields the cornea from environmental stress, and bathes it with body-temperature saline. This silences corneal nociceptors. Over a week, this reduces patient reaction to cool and dry air. When we put the lens in the eye, patients say it’s like getting their life back. how often do you get that response from your dry-eye patients?”

Pharmaceutical interventions that inhibit cytokine and MMP activity also have been found to prevent corneal barrier disruption in response to acute desiccating stress in mice, Dr Pflugfelder said. Dexamethasone, doxycycline and cyclosporine all have been shown to improve optical performance. T helper cytokine inhibitors, selective glucocorticoid receptor agonists, MMP inhibitors and leukocyte trafficking blockers, including LFA-1, VLA-4 and chemokine receptor 2 antagonists, all show promise for tamping down corneal stress signalling and resulting damage.

Stephen Pflugfelder – stevenp@bcm.edu

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TEAR DYSFUNCTIONEmerging therapies show promise for reducing pain and improving visionby Howard Larkin in Orlando

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Update

CORNEA

Is it better to perform a combined cataract and Descemet’s stripping endothelial keratoplasty (DSEK) in patients with Fuchs’ dystrophy or

should surgeons opt instead for a staged approach of two separate procedures?

At a special debate session held during the World Ophthalmology Congress, Pravin K Vaddavalli MD argued the case for the former approach while Rudy Nuijts MD, PhD, outlined the benefits of a staged approach.

Dr Vaddavalli, associate ophthalmologist at the LV Prasad Eye Institute, Hyderabad, India, said that while specific cases may warrant a staged procedure depending on the severity of the cataract and progression of the dystrophy, there were valid arguments in favour of combining the procedures for many patients. “The main reason why I think we should do it together is because it is one surgery, and the results of combined DSEK with cataract surgery have excellent visual outcomes and very good refractive stability that are comparable to those patients who have DSEK alone,” he said.

He noted that cataract surgery in patients with Fuchs’ corneal dystrophy presents a particular challenge because of the endothelial cell loss associated with phacoemulsification. Looking at the scientific literature, Dr Vaddavalli said that intraocular surgery in a normal cornea results in an average loss of between 11 per cent to 15 per cent of the endothelial cells.

“This is no different in cataract surgery in Fuchs’ dystrophy patients, with a loss of about 11 per cent to 12 per cent of endothelial cells, although the absolute number of cells lost is probably less because you are starting off with less cells in the first place. So if you do cataract surgery in a patient with Fuchs’ dystrophy it will probably tip the balance from a patient with no corneal oedema to one with oedema,” he said.

In terms of visual function, Dr Vaddavalli cited a 2011 study by van de Meulen et al that found that quality of vision is severely impaired in patients with Fuchs’ dystrophy and improves significantly after DSEK.

“The amount of light scatter in these patients was significantly greater than age matched controls who may or may not have a cataract. As this light scatter can be removed by performing a DSEK surgery, it seems that the corneal endothelial changes or changes in the stroma might themselves cause a reduced

visual function in patients with Fuchs’ dystrophy,” he said.

Appropriate selection Presenting the case for a staged procedure, Dr Nuijts said that it is first of all important to establish whether the primary cause of vision loss is cataract or Fuchs’ endothelial dystrophy.

“The criteria for the selection can be based on corneal thickness, but also signs such as early morning decompensation, endothelial cell density, firmness of the cataract and quality of vision,” he said.

Once the patient has been identified as being a good candidate for a staged procedure, the main preoccupation of the surgeon is to prevent postoperative corneal decompensation from the cataract procedure, said Dr Nuijts. “The risk factors for endothelial cell loss are the firmness of the nucleus, shorter eyes, longer phacoemulsification time and complications. What is very important in this category of patients is that the surgeon prevents contact of the fragments with the endothelium, and discusses the risk of decompensation with the patient,” he said.

Dr Nuijts said that the soft shell technique pioneered by Steve Arshinoff MD, combining a dispersive and a cohesive viscoelastic, has been shown to be particularly helpful in protecting the compromised corneal endothelium in Fuchs’ dystrophy patients.

In terms of phacoemulsification, Dr Nuijts said a literature survey did not indicate any clear advantage for particular nucleotomy techniques, but noted that torsional ultrasound technology may well offer advantages over traditional longitudinal ultrasound for these patients.

This was confirmed by a randomised study carried out by Dr Nuijts and co-workers looking at the corneal thickness changes in Fuchs' endothelial dystrophy patients who underwent either torsional or conventional phacoemulsification.

“We found that torsional phacoemulsification resulted in less US time and less cumulative dissipated energy (CDE), especially in the higher grades of cataract (see figure above). We also saw less swelling of the cornea at day one with torsional compared to longitudinal ultrasound,” he said.

Dr Nuijts said it was also important to bear in mind the disadvantages of doing a combined procedure in such patients.

“As well as the intraoperative disadvantages of a smaller capsulorhexis, and issues with lens iris diaphragm visibility and mobility, there are also the postoperative problems of the unpredictability of the refractive effect, since not all eyes with DSEK improve and there is a continuing loss of endothelial cells after keratoplasty. There is an incidence of

corneal graft rejection of up to 9 per cent and we also have IOP pressure spikes that may be caused by the use of corticosteroids in up to 30 per cent of cases,” he said.

Dr Nuijts said that phacoemulsification might be considered as the preferred option for a standalone procedure if the corneal thickness is 620 microns or less.

Update

cornea

EUROTIMES | Volume 17 | Issue 7/8

Pravin K Vaddavalli – pravin@lvpei.orgRudy Nuijts – rudy.nuijts@mumc.nlMuriel Doors – muriel.doors@mumc.nl

cont

acts

FUCHS’ DYSTROPHYDebate explores optimal approach for treating cataract in patients with Fuchs’ dystrophyby Dermot McGrath in Abu Dhabi

21

Ultrasound time (left) and Cumulative Dissipated Energy (CDE) (right) for each nucleus density grade, with longitudinal phacoemulsification in red and torsional phacoemulsification in blue bars. P-values: independent sample t-test between the two groups

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Update

GLaUcoMa

EUROTIMES | Volume 17 | Issue 7/8

A combination of micro-incision cataract surgery and implantation of an Ex-PRESS Glaucoma Filtration Device (Alcon

Laboratories Inc.) under a scleral flap appears to provide a safe, simple and effective way to reduce IOP and the need for anti-glaucoma medication in eyes with open-angle glaucoma (OAG) and cataract, said Romeo Altafini MD, director of Glaucoma Surgery Dept, San Bassiano Hospital, Bassano del Grappa, Vicenza, Italy.

“The advantage of the implant over trabeculectomy is that you don't have to

perform iridectomy, which results in a lower level of inflammatory reaction in the eyes with less scarring and major postoperative complications,” he told the 16th ESCRS Winter Meeting.

Dr Altafini noted that in a study he and his associates carried out involving 48 eyes of 41 patients with primary open-angle glaucoma (POAG) and cataract that underwent the combined procedure, the mean IOP remained at less than half preoperative levels at two years' follow-up.

That is, the mean IOP decreased from 24.7 mmHg preoperatively to 10.5 mmHg at six

months and to 11.3 mmHg after the second postoperative year. Furthermore, the average number of medications patients required to maintain the target IOP of 18 mmHg or less fell from 1.97 preoperatively, to 0.37 after a follow-up of up to two years.

The MICS-Express technique Prior to surgery, all eyes received topical anaesthesia with four per cent lidocaine applied to the conjunctiva with a sponge for 30 seconds. Dr Altafini then created a fornix-based conjunctival incision and used a crescent knife to create 4.0mm by 4.0mm scleral flap. He made his incisions starting from the limbus in the clear cornea and proceeding to the fornix in order to have a small scleral flap with good visualisation of the limbal transition zone.

All eyes in the study underwent clear-corneal MICS with a Stellaris phacoemulsification machine (Bausch + Lomb) and implantation of a MI60 micro-incision IOL (Bausch + Lomb) through a 2.2mm incision. In all cases he used a dual linear pedal phaco-chop technique during phacoemulsification, which allows the precise modulation of vacuum and ultrasound energy according to the requirements of each individual case.

“This technique is very fast and easy to use even in a hard nucleus. The MA 60 IOL has a good stability in the capsular bag thanks to its four haptic design. We obtained good quality of vision due to the asphericity of the optic,” he added.

Before implanting the P 50 Ex-PRESS model Dr Altafini filled the anterior chamber with a cohesive viscoelastic device and used a 25-gauge needle coloured with methylene blue to create a scleral tunnel before implanting the device beneath the scleral flap.

The Ex-PRESS P 50 device is a stainless steel device consisting of a 27-gauge shaft with an outer diameter of 0.4mm and a 50 micron axial lumen. The shaft terminates in a faceplate, which fits into the scleral flap. The device was originally designed to direct drainage directly from the anterior chamber to the subconjunctival space. However, implanting the device under the conjunctiva resulted, most of the time, in extrusion of the Ex-PRESS. So Eli Dahan MD suggested implanting the device under scleral flap.

“The Ex-PRESS device allows the passage of aqueous humour from the anterior chamber to the subconjunctival space and by placing it beneath the scleral flap. Only if the sleral flap is too thin we had extrusion of the device,” Dr Altafini said.

In order to prevent scarring of the sclera and conjunctiva to maintain the patency of the bleb for 15 days, Dr Altafini injected reticulate hyaluronic acid beneath the scleral flap after suturing it down, with a 10-0 nylon suture. He then injected more of the viscoelastic on top of the scleral flap before closing the conjunctival wound with a 7-0 re-absorbable suture.

Postoperative complications in the study included three cases of shallow of the anterior chamber, two of which were resolved with viscoelastic injection, while the remaining case required a re-suturing of the conjunctiva. In addition, one eye developed postoperative endophthalmitis 15 days after surgery, which was resolved by vitrectomy and silicon oil injection. There were also five cases of high IOP spikes immediately after surgery, the IOP spike was reduced, by argon laser lysis of the nylon suture.

Dr Altafini noted that previous studies by comparing trabeculectomy versus the implantation of the Ex-PRESS device beneath the scleral flap showed that there was no significant difference between the two techniques in terms of IOP reduction. However, they also showed that among eyes with the Ex-PRESS device there were lower rates of complications such as choroidal effusion and early postoperative hypotony.

“After two years of follow-up the Ex-PRESS device with the injection of reticulate hyaluronic acid below and on the top of the scleral flap and combined with 2.0mm MICS and IOL implantation was safe, simple and effective for reducing IOP and anti-glaucoma medication in eyes with open angle glaucoma and cataract,” he concluded.

Romeo Altafini – raltafi@tin.it

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act

FILTRATION DEVICECombined procedure provides sustained IOP reduction by Roibeard O’hEineachain in Prague

22

MI60 microincision IOL

Ex-PRESS Glaucoma Filtration Device under scleral flap

The advantage of the implant over trabeculectomy is that you don’t have to perform iridectomy, which results in a lower level of inflammatory reaction in the eyes with less scarring and major postoperative complications

“

Romeo Altafini MD

Cour

tesy

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omeo

Alta

fini M

D

Romeo Altafini – raltafi@tin.it

EUROTIMES_July 2012 ads_Layout 1 6/11/12 1:37 PM Page 3

24

EUROTIMES | Volume 17 | Issue 7/8

The study of brain changes in glaucoma may provide new insights into the pathobiology of glaucomatous damage and disease

progression and stimulate new detection and therapeutic strategies to prevent blindness, according to Neeru Gupta MD, PhD.

“There is now abundant evidence that glaucoma is a neurodegenerative disease that affects the central visual system. This is borne out by our own research over the last decade as well as work from other laboratories around the world. It is clear that if we want to do something about glaucoma we should be tackling the eye but also remembering that we need to follow up with the connections to the brain, focusing on structures such as the retinal ganglion cell and lateral geniculate nucleus,” Dr Gupta told delegates attending the World Glaucoma Congress.

Dr Gupta, professor and Dorothy Pitts chair of ophthalmology and vision sciences, and laboratory medicine and pathobiology at St Michael’s Hospital, University of Toronto, said that it was important to consider other factors beyond optic disc changes in recognising and treating glaucoma.

“If we want to move forward, it may be worthwhile to explore some of the processes that go into the visual aspects that take place in the brain,” she said.

While a lot of work in glaucoma research and treatment has focused on measures to lower intraocular pressure, Dr Gupta said that the elephant in the room is the fact that many patients will continue to lose sight despite treatment.

One promising avenue of research has been to focus on the target of retinal ganglion cells, the lateral geniculate nucleus (LGN), a structure located in the thalamus of the brain which serves as the primary relay centre for visual information received from the retina.

Dr Gupta described the LGN as a very special structure exquisitely organised into six distinctive layers: the ventral two magnocellular layers and the dorsal four parvocellular layers. An additional set of neurons, known as the koniocellular sublayers, are found ventral to each of the magnocellular and parvocellular layers.

In studies of experimental monkey glaucoma with optic nerve fibre loss, the LGN was shown to undergo significant

degenerative changes, including overall LGN shrinkage and reduced neuron size and number, said Dr Gupta.

There is also evidence that the same process holds true for humans. In 2006, Dr Gupta’s group published the results of a post-mortem human glaucoma case with bilateral visual-field loss in which reduced LGN and neuron size were observed by histomorphometry and ex vivo MRI scans compared with age-matched controls. In the same study, pre-chiasmal optic nerve and visual cortex changes were also seen. In 2009, Dr Gupta and colleagues looked at patients with glaucoma, and evaluated the structure of the LGN by MRI. This work provides evidence of significant LGN atrophy in human disease.

New techniques The use of latest-generation imaging technologies, in particular MRI scanning techniques, is helping to transform understanding of the role of the brain in glaucoma, said Dr Gupta. Functional magnetic resonance imaging (fMRI), a non-invasive means of inferring function-specific neuronal activity, enables researchers to evaluate glaucomatous changes in neuronal activity throughout the visual pathway in vivo.

Recent glaucoma research has focused on the potentially protective effects of memantine, a neuroprotective agent used in neurodegenerative diseases such as Parkinson’s disease and Alzheimer’s disease. In a 2006 study of memantine in monkey glaucoma, Yucel et al showed that memantine attenuates LGN neuron shrinkage.

Following up this work, more recently, Dr Gupta’s group used Sholl analysis to demonstrate that dendrites in monkey LGN have reduced complexity.

“We specifically evaluated dendrite complexity under the microscope and saw a significant increase in dendrite complexity in glaucoma subjects treated with oral memantine compared to those with glaucoma that received only vehicle. This tells us that there is an opportunity to change the wiring in the brain with new treatments as we learn more about visual system degeneration in glaucoma,” she said.

contact Neeru Gupta – guptan@smh.ca

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EUROTIMES | Volume 17 | Issue 7/8

Combined phacoemulsification and trabeculectomy surgeries tend to amount to less than the sum of their parts in terms of

intraocular pressure reduction. A better option is to perform the cataract surgery first and then, around six months later, perform the trabeculectomy if necessary, said Thierry Zeyen MD, University Hospitals, Leuven, Belgium, at the XXIX Congress of the ESCRS.

Prof Zeyen noted that phacoemulsification on its own can lower IOP by around 6.0 mmHg in eyes with angle-closure glaucoma, and by 1.0 to 3.0 mmHg in eyes with primary open-angle glaucoma (POAG), as it does in eyes with no glaucoma at all, even after two years.

“We don’t really know for sure what the mechanism of action is behind this IOP reduction. Probably it’s the deepening of the anterior chamber, the opening of the angle and the stretching of the trabeculum

via the contraction of the capsular bag,” Prof Zeyen said.

On the other hand, combined phacoemulsification and trabeculectomy procedures reduce IOP less than trabeculectomy alone, he pointed out. That is, a phaco-trabeculectomy procedure achieves an IOP reduction of only 5.0 to 7.0 mmHg, compared to an average IOP reduction of 9.0 to 12 mmHg following trabeculectomy alone, he noted.

“Trabeculectomies work less well in combined procedures simply because of the long-lasting (often subclinical) inflammation. Phacoemulsification also compromises the function of pre-existing blebs, even with small incision clear corneal procedures, usually resulting in an increase of 1-2 mmHg. Phacoemulsification also makes blebs flatter and a little bit more vascularised, probably due to a prolonged subclinical inflammation after phaco,” Prof Zeyen said.

Phacoemulsification is generally more difficult in glaucoma patients because of such features common to eyes with the disease, such as small pupils and pseudoexfoliation. In addition, the postoperative refraction is less predictable in combined surgery because of unforeseeable anterior chamber depth, especially early after surgery or after needling procedures resulting in a (temporary) myopic shift. Finally, a postoperative shallow anterior chamber may result in a subluxation of the IOL.

Phaco first Prof Zeyen noted that the European Glaucoma Society’s current guidelines state that, “the success rate of combined phacoemulsification and filtration surgery is not as favourable as filtration surgery alone,” and that “there is no evidence to support a generalised switch from sequential to combined surgery.”

He added that his own recommendation is to perform phacoemulsification first, to avoid damaging a filtering bleb, and then wait for six months, by which time the inflammation will have largely dissipated, before performing the trabeculectomy.

He noted that in some cases, particularly those with angle-closure glaucoma, further IOP reductions may not be necessary after phacoemulsification. Furthermore, among eyes in which IOP remains elevated, trabeculectomy may not be necessary because the cataract procedure will have greatly facilitated the performance of laser trabeculoplasty procedures, and some eyes may obtain an adequate response from topical medications.

At the same time, there remain some cataract patients within whom trabeculectomy should be performed first, Prof Zeyen maintained. Those cases include patients whose visual function is threatened by such factors as extreme IOP elevation, advanced optic disc cupping or visual field defects close to the point of fixation. Phacoemulsification should then be postponed for at least six months in order to protect the filtration bleb.

However, a phaco-trabeculectomy is a valid option in patients who insist on undergoing only one surgical procedure. In those patients, it is advisable to spare one quadrant of conjunctiva in case a second

trabeculectomy is necessary in the future, he added.

Prof Zeyen noted that studies have shown that in eyes with angle-closure glaucoma and <180° of goniosynechiae, phacoemulsification reduces IOP, by around 6.0mm while laser iridotomy reduces IOP by only 3.0 mmHg on average. He added that a prospective randomised clinical trial (RCT), called the EAGLE study, is currently carried out to evaluate whether early phacoemulsification of the crystalline lens will provide better results than conventional stepped approach (peripheral iridotomy -> medical treatment -> glaucoma surgery) in the treatment of primary angle-closure glaucoma.

New combined procedures Novel ab interno glaucoma procedures can easily be combined with small incision phacoemulsification. iStent (Glaukos) and Trabectome (Neomedix) combined with phacoemulsification can decrease the IOP with 3 to 5 mmHg. This can be enough to control the pressure in some patients and to reduce the need for postoperative medication. A third generation iStent is currently under study and it might be that more than one stent needs to be implanted to improve the results, Prof Zeyen said.

The combination of Cypass (Transcend Medical), a micro-stent introduced gonioscopically to promote uveo-scleral outflow, or Hydrus (Ivantis), a new Schlemm’s canal scaffold, with phaco-surgery may have a more significant IOP lowering effect but long-term results are not yet published, he added.

Canaloplasty (iScience) can be combined with phacoemulsification as well but is a more challenging surgery, needing a separate conjunctival and scleral dissection. However, if a tension suture can be placed, a considerable IOP decrease (around 10mmHg) might be expected. Late onset cheese wiring has been described, causing the suture to become exposed in the anterior chamber, according to Prof Zeyen.

Endoscopic photocoagulation is another procedure that can produce good IOP reductions when used in combination with phacoemulsification. It can be performed directly after completion of cataract removal. However, since it is a procedure which blocks aqueous inflow, it is inherently less preferable than procedures that enhance aqueous outflow, Prof Zeyen added.

Those above mentioned new combined procedures are promising but RCT’s, conducted independently from the manufacturers, and comparing combined phacoemulsification and novel procedures with phaco-trabeculectomy or trabeculectomy alone are necessary to assess their long-term safety and efficacy, Prof Zeyen concluded.

Thierry Zeyen – thierry.zeyen@uzleuven.be

cont

act

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Trabeculectomies work less well in combined procedures simply because of the long-lasting (often subclinical) inflammation

“

Thierry Zeyen MD

27

EUROTIMES | Volume 17 | Issue 7/8

Precision modification of the genome will soon become a reality in the clinic, Luigi Naldini MD, PhD, director, HSR-TIGET, San Raffaele

Telethon Institute for Gene Therapy told a session of the EURETINA Winter meeting.

Prof Naldini presented an overview of some recent advances and applications of gene therapy for the treatment of a broad range of genetic diseases, including ocular disorders. “The concept of gene therapy, exploiting genes as therapeutics and transferring those genes into cells to express, or to replace a malfunctioning gene or to instruct a novel function,” was a familiar concept. However, Prof Naldini explained that efficient gene transfer in the clinic is largely dependent on engineered viruses to mediate efficient insertion of foreign genes into target sites. The main vectors used for gene therapy are derived from adeno-associated virus, lentiviruses and adenoviruses.

Targetting the eye He outlined several challenges to be met by gene therapy, including regulation of delivered transgenes and insertional mutagenesis. Efficient vectors will be required to target many organs. The eye may be a suitable target as there are relatively few cell types to reach. Long-lived tissue cells are somewhat more amenable to stable gene transfer and they don’t necessarily need integration of the vector. Contrastingly, stem cells require stable insertion of the gene to allow for maintenance of the delivered gene throughout the progeny of the cell.

There are significantly improved vectors available to researchers today, including lentiviral vectors, originally designed to improve efficiency of conventional gamma retroviral vectors. One example of the use of lentiviral vectors is a trial currently being performed at Prof Naldini’s institute demonstrating the efficiency of these gene therapy vectors. The trial uses hematopoietic stem cells taken from a patient and then modified to correct the genetic fault before re-transplantation back into the patient to repopulate the whole hematopoietic lineage.

Prof Naldini’s team, using such technique, has developed a treatment for a lysosomal storage disorder which affects most tissues in the body, including the CNS and

sometimes the retina, in which significant tissue damage can occur. “The rationale of using HSC therapy is because the progeny of the cells will migrate into the tissue to become macrophages which are scavenger cells and so if the cells are now genetically modified so that they are able to scavenge and destroy the storage material, you can then ameliorate the effect”.

The disease being targeted is a severe storage disorder of early childhood for which there is no current treatment, a disorder known as metachromatic leukodystrophy. Transplantation of genetically modified autologous stem cells to metachromatic leukodystrophy patients, more than one year after transplantation, show that a majority of the blood cells of such patients successfully carry the corrected transgene.

The genetically modified cells express the required enzyme to a high level and, according to Prof Naldini, “where before there was no [gene] expression, now there is up to ten-fold normal expression and this has allowed the child, for which we expected a dramatic decrease in motor performance and mental capacity, to prevent this disease at one-year follow-up and this is now being applied to other patients today”.

He proposed to delegates that such “gene therapy may become a real option or choice potentially applicable to any patient in comparison to donor-derived allogenic transplant which has limited application”.

Another challenge for gene therapy is to develop tight controls that limit the expression of the transgene to the cell type in which it is required. “Whether to prevent transgene toxicity or to prevent an immune response we need to be able to stringently target the transgene expression into the desired cell type. To do this we use promoters derived from tissue specific genes so your transgene will mostly express in the tissue that you want”.

In addition, Prof Naldini stated that “while we don’t invent much, we do learn from nature and nature has actually developed a system for the post-transcriptional regulation of a gene based on micro RNA”.

Micro RNAs are non-coding RNAs which act to regulate other genes by repressing translation.

gENE THERAPYChallenge to develop controls that limit the expression of the transgene to required cellby Gearóid Tuohy PhD in Rome

contact Luigi Naldini – naldini.luigi@hsr.it

Update

retina

Update

paediatric ophthaLMoLoGy

EUROTIMES | Volume 17 | Issue 7/8

As the epidemiology of paediatric blindness in the developing world continues to change, so the ophthalmic profession must

alter its strategy and foster a multisectoral approach if the burden of blindness in these countries is to be reduced, Parikshit Gogate MD told delegates attending the World Ophthalmology Congress.

“We need ultimately a multisectoral team effort engaging ophthalmologists, general practitioners, optometrists, paediatricians, teachers, educationists, ophthalmic assistants, healthcare assistants and community medicine specialists in order to combat childhood blindness and visual impairment,” he emphasised.

Dr Gogate, an ophthalmologist in practice in Maharashtra, India, said that paediatric blindness was not just a public health issue.

“A child is a veritable asset and represents a nation’s and a community’s future. Blindness and visual impairment in children does not just affect a child’s vision

but also his or her mobility, education and development and it has immense social and economic costs. That is why childhood blindness has always been a priority because the causes are different from adults and many are preventable at the community level,” he said.

Dr Gogate said that the pattern of childhood blindness has changed since Vision 2020 set out its initial roadmap for the prevention of paediatric blindness over a decade ago.

“Now that we are at the midpoint of Vision 2020 a lot of things have changed on the ground. This is partly because of the success of Vision 2020 in reducing the global prevalence of blindness from 0.75 per 1,000 population to 0.4 per 1,000 by seeking to eliminate corneal scarring, congenital rubella and by introducing prompt surgery for childhood cataract. Vision screening in schools to detect and treat refractive errors has also played an important role,” he said.

The upshot of such targeted campaigns is that eye conditions that were not considered a priority before are increasingly implicated in childhood blindness, said Dr Gogate. Refractive error is now responsible for visual impairment in an estimated 9.2 million children worldwide. Trauma is implicated in 20 per cent to 40 per cent of unilateral blindness, while conditions such as strabismus and amblyopia also represent a major cause of social suffering and visual impairment. Another change is that congenital anomalies are also appearing more frequently in developing countries, he said.

Dr Gogate said that the most striking changes have occurred in developing countries over the past decade. “General economic growth and improved healthcare planning have resulted in an increasing number of eye care providers in these countries, and we are now seeing doctors setting up private practice in rural areas. In the last 20 years, Africa has seen a four- to five-fold increase in the number of ophthalmologists with increased distribution of services outside the capital cities. Programmes have been put in place to reduce the use of harmful traditional eye medicines and practices, further decreasing the risk of corneal conditions,” he said.

Economic development The rapid pace of economic development in countries such as India and other developing countries is underpinning many of these changes, said Dr Gogate.

“India, for instance, has significantly improved its primary healthcare infrastructure and NGO hospitals are providing high-quality low-cost eye care across the country. There is also easier and cheaper availability of antibiotics and better managed procurement and distribution systems. And while ocular injuries have not been eliminated, trauma and infection are less likely to lead to blindness than previously. ORBIS International has done yeoman's work for combating childhood blindness in India,” he said.

In terms of primary healthcare, screening programmes for disease and refractive errors in kindergartens and primary schools have had a positive effect on the paediatric blindness rates in certain regions. Other measures such as programmes to target vitamin A deficiency, measles immunisation,

and treatment of ocular infections and trauma have also played a role, he said.

Significant advances have also been made at the tertiary level, said Dr Gogate, citing measures such as improved paediatric cataract and glaucoma surgery, screening and treatment of retinoblastoma and ROP, squint and ptosis correction and genetic counselling.

Nevertheless the cost of establishing dedicated healthcare facilities remains a brake on progress in many developing countries.

“Setting up a paediatric eye centre costs an enormous amount of money. Surgical services are an expensive proposition in terms of equipment, instrumentation and trained human resources. The World Health Organisation (WHO) recommends that there be at least one paediatric eye centre per 10 million population, which is far from being the case in some regions,” he said.

Some progress is being made, however. India has added at least 20 paediatric eye centres in the past decade and there are now around 26 centres in 10 countries of sub-Saharan Africa, said Dr Gogate.

In developed countries, central nervous system lesions, congenital anomalies and retinal disorders are among the main causes of paediatric blindness and visual impairment. In middle-income countries, congenital cataract, glaucoma and ROP are the primary culprits.

Dr Gogate also pinpointed what he called the “life versus sight” paradox associated with retinopathy of prematurity in developing countries.

“As more neonatal units are springing up, we see paradoxically that the healthcare system which saves a premature baby’s life may see that same baby develop ROP if the clinic does not monitor and follow up the baby properly,” he said.

Looking to the future, Dr Gogate said that much remains to be done to achieve the Vision 2020 targets in terms of childhood blindness. He concluded that one cost-effective way to improve the current situation would be to engage parents more directly in the ocular care of their children.

“We should remember to make parents our partners because they have the biggest stake in their children and are finally the ones who will implement the medicine or follow-up care that is needed to prevent blindness in children,” he said.

Parikshit Gogate – parikshitgogate@hotmail.com

cont

act

PARENTS MUST BE PARTNERSMultisectoral team effort needed to combat childhood blindness and visual impairmentby Dermot McGrath in Abu Dhabi

28

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One of Belgium’s most renowned ophthalmologists, Jean-Jacques De Laey MD, PhD, was honoured at the European Board of Ophthalmology (EBO) Diploma Award

Ceremony as the second recipient of the Peter Eustace Medal for his contribution to ophthalmic education in Europe.

“Prof De Laey was a unanimous choice of the EBO Board to receive the Peter Eustace Medal for his tireless efforts on behalf of education in ophthalmology in Europe and around the world over the course of his career,” said Wagih Aclimandos FRCS, FRCOphth, FEBO, president of the EBO. “Following on from last year’s award winner, Gisèle Soubrane, Jean-Jacques De Laey is another past-president of the EBO and his belief and support for the cause of education and training in Europe has been unwavering,” he said.

Prof Aclimandos said that the Peter Eustace Medal had been established by the EBO as a token of appreciation of the tireless work of Prof Peter Eustace from Ireland who established the first EBO Diploma (EBOD) examination in Milan in 1995.

Paying tribute to Prof De Laey, Prof Aclimandos said that his contribution to European ophthalmology over many years had made him a worthy recipient of the Peter Eustace Medal.

“Prof De Laey graduated in medicine at the University of Ghent in 1966 and became an ophthalmologist in 1970. After successfully defending

his PhD in 1977, Prof De Laey served as chair of the Department of Ophthalmology in Ghent from 1979 until 2006. He has been extremely active with the International Council of Ophthalmology,” he said.

Prof De Laey’s connection to the EBO stretches back to the very beginning of the organisation, noted Prof Aclimandos. “He served as president of the EBO from 1994 to 1996, and he was also chairman of the EBO Residency Review Committee for four years. As one of the founders of the EBO and one of the first to examine for the EBOD, Prof De Laey has demonstrated his commitment to the cause of ophthalmic education over many years,” said Prof Aclimandos.

As an educator and teacher, Prof De Laey’s contribution makes him an extremely deserving recipient of the Peter Eustace Medal, said Prof Aclimandos.

Accepting the Peter Eustace Medal, Prof De Laey said it was a wonderful privilege to receive such an honour. “When I think back to when we organised the first EBO examination in Milan with Peter Eustace in 1995, we had only about 25 candidates present. Today we have over 370 candidates, which is a measure of how much has been achieved over the years. I am very pleased because I think the EBO has done a tremendous job and I am truly very honoured to have been recognised with this award,” he said.

News

eBoEuropean Board of Ophthalmology

EUROTIMES | Volume 17 | Issue 7/8

Continuing the upward momentum of recent years, a record-breaking 358 candidates from 25 European countries came to Paris this year to take part in the 2012 European Board of

Ophthalmology Diploma (EBOD) examination.“We are honoured and extremely happy to announce that

the 2012 examination has once again attracted such a high number of candidates. I think this underscores the growing significance and prestige of the EBO qualification for so many of our young ophthalmologist residents and specialists,” said Wagih Aclimandos FRCS, FRCOphth, FEBO, president of the European Board of Ophthalmology (EBO).

Held every year in Paris, the EBOD examination is designed to assess the knowledge and clinical skills requisite to the delivery of a high standard of ophthalmic care both in hospitals and in independent clinical practices.

Congratulating the candidates on their achievement, Prof Aclimandos said that this year’s pass rate of 89.6 per cent was consistent with previous years and reflected the rigorous study and hard work of the candidates in their quest to attain the high standards expected of Fellows of the European Board of Ophthalmology.

“The exam is always a very important highlight in the EBO calendar, because the organisation is all about attaining high levels of training and experience in ophthalmology across Europe. We are here to celebrate those that have attained that level and also to give credit to those who have contributed to them reaching that level by helping in their training and their teaching,” he said.

In this respect, Prof Aclimandos paid tribute to the 194 examiners who travelled from all over Europe to make up the panel of skilled, multilingual EBO examiners, all experts in their various fields.

“We are extremely grateful to all those examiners who give up their valuable time and make the effort to join us in Paris every year. It is a fitting example of the European spirit of quality and collaboration and we are deeply appreciative of their efforts to advance the cause of training and education in ophthalmology in Europe,” he said.

As in previous years, the EBOD examination comprises a multiple choice written exam (MCQ) as well as a four-part viva-voce exam, the latter seeing each candidate examined on the four key topics of ophthalmology by a team of examiners.

Candidates who succeed in passing the examination receive an EBO certificate and earn the right to use the title “Fellow of the European Board of Ophthalmology (FEBO)” after their name.

Special awards were presented this year to Canan Asli Utine Yildirim from Turkey, who received the 2012 Alan Ridgway Award for best MCQs result, and Gil Santos of Portugal for the Best Overall EBOD result.

Wagih Aclimandos – wagih.a@ntlworld.com

cont

act

A gREAT SUCCESSA record-breaking 358 candidates from 25 European countries came to Paris for the 2012 EBOD examinationsby Dermot McGrath in Paris

30

jEAN-jACqUES DE LAEY HONOURED BY EBO

“we are honoured and extremely happy to announce that the 2012 examinations have once again attracted such a high number of candidates”

Wagih Aclimandos FRCS, FRCOphth, FEBO, president of the EBO

Jean-Jacques De Laey

EUROTIMES | Volume 17 | Issue 7/8

31EBO 2012 SUCCESS STORIES

A proud moment for Portuguese ophthalmologyGil Santos from Portugal was awarded the prize for Best Overall EBOD result.

“The main motivation for taking the EBO examination was to test more objectively the knowledge I gained during my residency. The examination took place a week after taking the final examination of my residency, which allowed a single effort in performing two different tasks. Compared to the EBO examination, the Portuguese examination is more subjective and therefore I felt the need to measure more accurately the effectiveness of my study.

“The structural concept of the examination is very interesting and more fair than the Portuguese examination. I think that it assesses more objectively

and comprehensively the knowledge of the candidates. However, I think that the preparation of multiple choice questions should be more careful, as some seemed to me very ambiguous and open to different interpretation.

“The overall experience was very positive because it allowed me to test my knowledge in a different context than the one to which I was accustomed. The experience also allowed the strengthening of the pride I have in my generation of ophthalmologists. This award is dedicated to all of them, especially to the Portuguese candidates who were in Paris and also to my co-workers at Centro Hospitalar de Entre o Douro e Vouga.

“My plan now is to consolidate the knowledge that I have systematised in the past four years and apply it consistently in my clinical practice in the best interests of patients.”

A tough but fair examinationCanan Asli Utine Yildirim from Turkey was the 2012 winner of the Alan Ridgway Award for best MCQs result.

“My main motivation for taking the EBO examination was that I wanted to test my knowledge in the European league.

“I was very surprised when I saw that I had won the Alan Ridgway Award. I knew I had done well enough to pass the exam, but I certainly didn’t expect to win any prizes. The exam is well designed in that it tests the candidate’s basic knowledge as well as their clinical approach.

“The exam experience was a positive experience for me and I was very happy to represent my country, Turkey, to the best of my ability. I believe this exam should be taken by all ophthalmologists that have just finished their residency.

“In terms of my career, for the moment I will continue to work in Yeditepe University Department of Ophthalmology in Istanbul.”

High-quality diploma in ophthalmologyPanagiota Founti from Greece shared second place in the Overall EBOD classification.

“Given the many differences in residency training programmes in ophthalmology across Europe, I thought it would be useful to have a diploma that represents high-quality training in ophthalmology. What would be even more useful in the future is a curriculum-based system of training in ophthalmology that would be applied in all European countries.

“While I felt I did really well in the oral part, I was less sure about the written part of the exam, because the multiple choice questions were just so tricky. Besides, with so many candidates from so many different countries, I do not think that anyone can really expect to be in the top list. I was very pleasantly surprised when I saw that I was among the top candidates.

“What I liked about the EBO examination is that it covered equally all fields of ophthalmology and that it required good understanding rather than simply good memory. I also liked the fact that there were different examiners from different countries involved. However it was stressful, simply because no matter how well you are prepared, examinations are always going to be stressful.

“I have been accepted for a year as a full-time teaching fellow at Moorfields Eye Hospital, so I am moving to London in a couple of months. Because I have been working for many years as a research fellow at the Aristotle University of Thessaloniki focusing on glaucoma, I will probably pursue a clinical fellowship in glaucoma in the future.”

A reference for future employers Rok Grcar from Slovenia shared second place in the Overall EBOD classification.

“My main motivation for taking the exam were the recommendations from previous Slovenian candidates as well as the possibility to obtain the EBO diploma, which will be recognised as one of the main references for future employers.

“The exam is quite stressful and exhausting since it is a one-day exam. The written part is tricky and demands detailed knowledge. The oral examiners were all fair and demanded more overall knowledge and general principles in ophthalmology, even though it is difficult to assess one’s knowledge in just seven minutes.

“Overall, the EBO exam was a positive experience for me.”

A well recognised qualificationChristian Böni from Switzerland came second place in the Alan Ridgway Award for best MCQs result.

“The EBO exam has now replaced the Swiss national specialist examination, so all the Swiss eye doctors participate in the EBO. The EBO offers a well-recognised qualification all over Europe.

“For the MCQs an in-depth knowledge was required, with intense learning in parallel to the clinical work. The oral part was an interesting exam, where your clinical knowledge in the whole field of ophthalmology was tested.

“It was great to meet so many interesting people from all over Europe. I plan to work for another year at the Eye Clinic of the University Hospital in Zurich, followed perhaps by a fellowship abroad.”

A chance to meet new peopleGregor Bauer from Switzerland shared second place in the Overall EBOD classification.

“In Switzerland the EBO exam is obligatory for specialisation in ophthalmology. My main aim was to pass the exam, but I was well prepared and after the oral examination I had a pretty good feeling about my performance.

“The exam was fair and the overall experience was largely positive and gave me the opportunity to meet a lot of new, interesting people.

“I have just begun training for ophthalmic surgery, concentrating initially on the anterior segment, and will be looking to develop my skills in the posterior segment afterwards.”

Improving one’s knowledgeChloe Turpin from France came third place in the Alan Ridgway Award for best MCQs result.

“I was motivated to take the EBO examination because the qualification is deemed necessary for working in French hospitals as ‘chef de Clinique’.

“While the written exam was not very stressful, it was quite difficult to have the correct answer because it often did not correspond to what we see in practice. I think clinical cases are more relevant than MCQs to evaluate medical students.

“I would recommend other residents to take the examination not just because it is mandatory for some but also provides a way to improve one’s knowledge in ophthalmology.”

Panagiota Founti, Greece, with diploma

Gil Santos, Portugal, winner of Best Overall EBOD result, pictured with Wagih Aclimandos (right), EBO president, and Peter Ringens, EBO general secretary

Alan Ridgway Award winner, Canan Asli Utine Yildirim from Turkey, with Wagih Aclimandos (right), EBO president, and Peter Ringens, EBO general secretary

32

EUROTIMES | Volume 17 | Issue 7/8

At a recent meeting of the Irish College of Ophthalmologists in Dublin, Dr Sonia Manning gave a workshop for trainees on:

“Useful Tips for Young Ophthalmologists”. The presentation by Dr Manning, a higher surgical trainee at the Mid-Western Regional Hospital, Limerick, Ireland, was excellent and advised trainees on “How to Plan Your Cataract Surgery”.

This is a subject that EuroTimes will return to in future issues and it is a subject that deserves the most serious consideration. But here is another useful tip for young

ophthalmologists: You will need to develop business skills as well as clinical skills in the course of your career.

This is one of the reasons that the ESCRS established a Practice Development Programme under the guidance of the Practice Development Committee, chaired by Dr Paul Rosen, UK. As Dr Rosen observes in his welcome note for the ESCRS Practice Development Weekend which takes place in Dublin from 5-7 October, 2012, health services need a strong financial base to survive and provide the support that patients deserve.

“This is particularly relevant in ophthalmology, where technological advancement has been stunning.”

The ESCRS Practice Development Weekend in Dublin and the Practice Development Workshops in Milan during the XXX ESCRS Congress will challenge ophthalmologists to look at new ways of building a sound business platform which will enhance the care of their patients. The programme for both meetings is aimed at ophthalmologists of all ages who work under different business models in different countries. ESCRS will be particularly pleased to see active engagement in the programmes from young ophthalmologists.

Early learning As noted earlier, the principal focus for trainees in their formative years will be on developing their clinical skills. But it should also be pointed out that ophthalmologists who complete their surgical training without knowledge of the business of ophthalmology may be at a disadvantage from colleagues who see themselves as both doctors and businessmen or women.

Dr Oliver Findl, chairman of the ESCRS Young Ophthalmologists’ Forum, is also a member of the ESCRS Practice Development Committee. “Diagnostic and treatment strategies are very important,” he said, “but young ophthalmologists should also be aware about the logistics of running an operating theatre, an outpatient clinic or an entire department, all of which require management and business skills.”

This is a topic which Dr Findl addressed at a Practice Development Masterclass at the XXIX ESCRS Congress in Vienna, Austria. Dr Findl said that by examining clinical processes and eliminating duplicate and unnecessary steps, his department in Hanusch Hospital Vienna, had increased volume by 35 per cent with the same staff. With healthcare costs exceeding 11 per cent of gross domestic product, Dr Findl said innovation within the public sector is essential to keep up. “Demand will increase, but budgets won’t,” he said.

* Colin Kerr is project manager of the ESCRS Practice Development Programme

USEFUL TIPSYoung ophthalmologists need business skills in a changing and challenging environmentby Colin Kerr

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Oliver Findl – oliver@findl.atPaul Rosen – Paul.Rosen@ouh.nhs.uk

cont

acts

In a few months' time, I will begin the oculoplastics and orbital disease rotation within my ophthalmology residency, so it was with great interest that I read Dr Hemant Mehta’s Oculoplasty: Innovative Simpler Techniques. This practical surgical guide is richly illustrated with pre-, peri- and postoperative photographs, surgical diagrams, and detailed anatomical sketches. A surgical technique DVD is included in order to deepen both the reader’s knowledge and his or her confidence in the operating room.

Dr Mehta, who has 32 years of experience as an ophthalmic surgeon in Wales, begins his text with fundamental techniques and summation of what he terms the 5 basic & fundamental procedures of oculoplasty:

1. Excision of lesions;2. Skin grafting & skin flaps;3. Multi-layer suturing;4. Exploiting the tarso-conjunctival flap;5. Spontaneous repair.

This list gives the young surgeon the comforting feeling that developing an overview of this complex sub-specialty is possible without having to practise for 32 years.

The text continues in Chapter 2 with a discussion of ‘minor’ common procedures, such as entropion and ectropion correction, trichiasis treatment, and blepharoplasty. These are the techniques of most use to the general ophthalmologist, particularly those who are interested in treating these conditions themselves rather than referring them to oculoplastic sub-specialists.

With the trend towards increased sub-specialisation in ophthalmology, there is a growing tendency to refer all surgical procedures to the sub-specialists. However, many common procedures, such as blepharoplasty, can be competently performed by non-specialists. Particularly useful are the descriptions of local and regional anaesthetic techniques, a crucial topic that is frequently overlooked in surgical manuals.

What is missing from the text, however, is any mention of Mohs' surgery. Considering the very small and highly complex periocular cutaneous anatomy, a statement like, “For malignant or suspected malignant lesions, an excision with at least 5mm clinical clearance

is implemented,” seems outdated. Mohs' surgery is maybe at its most useful in this field, and this technique should at least be referred to, even if not covered in this book.

Despite that, the book reads smoothly and is peppered with fun little anecdotes. Dr Mehta relates how a would-be American president, Abraham Lincoln, performed temporary tarsorrhaphy on pigs to make them easier to control back in 1831. Each chapter begins with the sort of insight that only a senior and experienced physician would have. For example, Chapter 9 begins: “The serious and at times tragic consequences that follow inexpertly repaired wounds…occur too frequently to be ignored.” He makes the case that these wounds should not be quickly treated in the emergency room, but should instead be planned for treatment under optimal operating conditions up to 48 hours later.

Another type of statement frequently seen in this text is one that repudiates what might have previously been common wisdom. For example: “One further ritual that needs to be abandoned is the Frost suture (which is) quite unnecessary.” Indeed, Dr Mehta seems to be in essence a minimalist, whose self-described modus operandi is “Perfection is achieved not when there is nothing more to add, but when there is nothing more to take away.” This occasionally gives the text a pleasantly philosophical tone.

But besides the beginners' introduction and the colourful stories, Dr Mehta discusses serious oculoplastic topics such as severe eyelid injuries and blowout fractures.

This book can be recommended to ophthalmology residents looking to brush up on their knowledge, fellows in oculoplasty seeking new insights, general ophthalmologists, and even oculoplastic specialists looking to read the advice of an experienced fellow surgeon.

33

EUROTIMES | Volume 17 | Issue 7/8

Review

Book reVieW

Oculoplasty fundamentals

If you a have a book you would like to have reviewed please send it to: EuroTimes, Temple House, Temple Road, Blackrock, Co Dublin, Ireland

BOOKS EDITORLeigh Spielberg

PUBLICATIONOcuLOpLaSty: InnOvatIve SImpLe technIqueS

AUThORhemant mehta

puBLISheD By pOStScrIpt meDIa

Oliver Findl – oliver@findl.atPaul Rosen – Paul.Rosen@ouh.nhs.uk

Practice manager Ed Toland MBA, of the Wellington Clinic, Dublin, Ireland, recalls a particularly messy group break-up in

another clinic from his days as a medical management consultant.

“Of the doctors in the partnership, one was bringing in 60 per cent of the revenue but receiving only 20 per cent of the profits,” Mr Toland recalls. In his mid-50s and facing uncertain retirement prospects, the energetic partner wanted more. After protracted negotiations, the group broke up.

The case shows that the choice of practice structure has profound long-term financial and cultural consequences. Yet it is often made with little or no reflection on the goals and personalities of the individuals involved, says Mr Toland, who will be presenting on practice business and financial planning at the Practice Development Workshops at the XXX ESCRS Congress in Milan.

“There is always a tendency among doctors to be the hail-fellow-well-met until it gets down to the nitty-gritty,” says Mr Toland, who has valued dozens of practices in Australia and Europe. But when money gets short, so do tempers. Financial problems often seem to strike out of nowhere in part because doctors typically have no idea what it actually costs – for rent, for staff, for supplies – for each service they provide.

What is needed is strategic and financial planning, Mr Toland says. Establishing upfront what your practice goals are and how you intend to achieve them, and how you will divide financial responsibilities can save a lot of trouble. Your strategy should then be tied to a concrete financial plan that takes into account your actual cost of overhead and your expected revenue volume. Periodic reviews of your financial assumptions can help you adjust your practice strategy as market conditions change.

Form follows function How you structure a private group depends largely on what kind of practice environment you and your colleagues want, Mr Toland says. He notes that the classic choice is between a partnership, in which all expenses and all proceeds are equally shared, and an association, in which expenses are shared, but members are paid in proportion to the revenue they bring in. Each has advantages and disadvantages.

Because it does not pit one doctor against another for pay, a partnership tends to promote cooperation and harmonious relationships within the practice, Mr Toland observes. “With an association, I’ve seen arguments at the front desk over which patients are being booked with which doctors. This can be very disruptive.”

On the other hand, a partnership may be less productive overall than an association because it provides less direct financial incentive for individual effort, Mr Toland points out. Also, the harmony can be destroyed if one or more partners feel taken advantage of. This feeling may develop over time for good cause, as in the case above. But it may also develop quickly when taking on new partners, he warns.

“Unless he/she is coming in with a ready-made practice, the new doctor will benefit from the goodwill established by your practice in the community. But once his/her practice is up and running after a few months, he/she may forget how it started and won’t understand that he/she has benefited from your goodwill, and may not want to pay to buy in,” Mr Toland says. Therefore, it is very important to establish upfront, in writing, what a new doctor will be paid, whether and under what circumstances they will be allowed to buy in, and the basis for valuing the buy-in.

Strong administration A trial period before a buy-in is a good idea to help determine how the new doctor will fit in, Mr Toland adds. A partnership may also decide to take on associates on salary without offering a buy-in.

Because it directly rewards extra work financially, an association tends to promote individual effort and innovation, Mr Toland explains. But this structure, too, can lead to real and imagined abuses,

leaving some doctors feeling they are being cheated by aggressive colleagues. Establishing clear rules of conduct and office procedures – and hiring a strong administrator – helps too. “Someone has to manage the staff so they don’t lose sight that they work for all the doctors collectively, or if they work for one doctor they still have a responsibility to the wider practice.”

Mr Toland notes that hybrids of partnerships and associations are emerging as a viable practice structure. These may share expenses and profits up to a point, but encourage doctors to bring in more revenue by allowing them to keep a larger share of profits once an overall financial target is met.

Whatever the practice structure, a clear vision of what the practice is and where it is going helps keep doctors and employees on track, Mr Toland says. “If you have a plan in place, everyone faces the sun and they have a better understanding of the organisation and how it creates value beyond each individual’s efforts.”

A private practice is a business, and a business cannot function well without financial oversight, Mr Toland emphasises. He recommends developing a five-year budget based on your practice. It doesn’t have to be extremely detailed, but it must be based on realistic assumptions about practice overhead. Benchmarking staff and other costs against other practices of similar size and services can improve financial performance. “I’ve seen nearly identical practices with one having twice the overhead of the other,” Mr Toland says.

The budget should be monitored continuously and used to revise practice strategy, Mr Toland says. For example, if you assumed a certain level of refractive demand two years ago, but your budget monitoring makes it clear your assumptions are not panning out, you can change course. “Once you know what your overheads are, you can stress test it and see the impact of a downturn in business,” he says. “This will help you manage through good times and in bad.”

Feature

practice deVeLopMent

EUROTIMES | Volume 17 | Issue 7/8

Ed Toland – ed.toland@wellingtoneyeclinic.com

cont

act

PARTNERS OR ASSOCIATES?The right group structure, tied to a solid budget, promotes long-term practice and financial successby Howard Larkin

34

Patients taking oral fluoroquinolone antibiotics appear to have a small but significant increased risk of developing retinal detachment, concludes a study following nearly one million patients for seven years. This is the latest entry on a list of ocular toxic effects possibly associated with this class of drugs.

Canadian researchers identified 4,384 cases of retinal detachment in a cohort of nearly one million patients. They compared them with 43, 840 controls selected from the same cohort. Some 3.3 per cent of patients currently taking fluoroquinolones developed a retinal detachment compared with 0.6 per cent of controls. No association was seen with recent or past use. The absolute increase in the risk of a retinal detachment was four per 10,000 person-years.

“Clinically, physicians treating people who’ve had a previous ocular condition that predisposes them to developing a detached retina, like cataract surgery, may want to consider prescribing an

alternative antibiotic. For your average Joe who needs an antibiotic, if the physician prescribes a fluoroquinolone, he or she might want to tell the patient that if he/she gets floaters

or flashes of light [in an eye] when starting these medications, to contact his ophthalmologist immediately because it may be a medical emergency, ” notes lead author Mahyar Etminan, PharmD, MSc(Epi) (pictured above), of the Child and Family Research Institute of British Columbia in Vancouver.

This is the first study to report an association between fluoroquinolones and retinal detachment. The researchers call for additional research to confirm or refute their observations. n The study appears in JAMA, M.

Etminan et al., 2012;307(13):1414-1419. doi: 10.1001/jama.2012.383.

Journal WatchRetinal detachment risk with oral fluoroquinolones

Establishing upfront what your practice goals are and how you intend to achieve them, and how you will divide financial responsibilities can save a lot of trouble

“

Ed Toland MBA

35

EUROTIMES | Volume 17 | Issue 7/8

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Macular bending increases risk of retinal pathologyMacular bending is a common clinical feature of highly myopic eyes and is associated with a range of retinal pathologies, according to the findings of a retrospective study. Macular bending is a smooth macular elevation found in optical coherence tomography (OCT) of patients with high myopia related to either dome-shaped macula or the border of an inferior staphyloma, the study's authors noted. Their review of 330 files, comprising all of the highly myopic eyes that have undergone OCT at a single clinic over a five-year period, showed that 68 eyes of 45 patients (13.63 per cent) presented with macular bending. Among those 68 eyes 41 (60.29 per cent) had retinal pathologies, including choroidal neovascularisation, subretinal fluid and macular holes.

(Coco et al, Ophthalmologica 2012; DOI:10.1159/000336910.)

SD OCT provides objective determination of vision lossSpectral domain optical coherence tomography (OCT) (Spectralis, Heidelberg Engineering) can reveal the morphological features most closely associated with vision loss in eyes with uveitic macular oedema, according to the results of a prospective study. The study included 71 eyes of 55 patients with uveitic macular oedema who underwent spectral domain OCT. The authors noted that logMAR best-corrected visual acuity was 0.2 in eyes with cystoid macular oedema, 0.1 in eyes with diffuse oedema (p = 0.008). Furthermore BCVA was 0.3 in eyes with serous retinal detachment and 0.2 in eyes without SRD (p = 0.02). Moreover, BCVA was 0.4 in eyes with inner segment/outer segment (IS/OS) disruption, 0.1 in eyes with integrity of the IS/OS junction (p = 0.01).

(Iannetti et al, Ophthalmologica 2012; DOI:10.1159/000337234.)

Mean foveal thicknessCataract surgery appears to increase mean foveal thickness in most patients but the increase persists longer in eyes of patients with diabetes and eyes with epiretinal membranes, a new study suggests. The study included a total of 202 eyes of

consecutive patients who underwent cataract surgery between November 2007 and June 2009. The researchers found that mean foveal thickness values were significantly higher at the first and third postoperative month than preoperatively (p < 0.01) in all groups, that is, in history-free patients, patients with diabetes mellitus without macular involvement at baseline, patients with glaucoma, and in patients with epiretinal membrane. However, by six months’ follow-up the mean foveal thickness remained elevated only in patients with diabetes and epiretinal membranes. Visual outcomes appeared to be unaffected by the increases in foveal thickness observed in the study, the authors added.

(Tsilimbaris et al, Ophthalmologica 2012; DOI:10.1159/000336908.)

Optic disc drusenCareful ophthalmoscopic examination of the morphological features of eyes with retinal pathology can help distinguish between optic disc drusen and papilloedema, according to the findings of a new study. The study's authors compared 100 eyes of 55 patients with confirmed optic disc drusen with 100 eyes of 60 patients presenting for differential diagnosis. Comparison of eyes with hidden optic disc drusen with eyes having papilloedema showed statistically significant differences in blurred edges, disc elevation, absence of optic disc cupping, altered colour, anomalous vascular branching and optic disc haemorrhages (p < 0.005), the study’s authors noted.

(Flores-Rodríguez et al, Ophthalmologica 2012; DOI:10.1159/000337842.)

Review

ophthaLMoLoGica

José Cunha-VazEDITOR OF OPHTHALMOLOGICA,The peer-reviewed journal of EURETINA

Feature

eU MaTTers

EUROTIMES | Volume 17 | Issue 7/8

Europe's highest court has ruled that patient safety cannot be compromised to save money on medicines. The European Court of

Justice has found that a Polish law allowing hospitals to import drugs that were not properly authorised violated established EU law.

Under Poland’s Law on Medicinal Products, a medicine that was available in any other country but which was not already authorised for use in Poland could be imported into and marketed in

Poland if the drug had the same active substances, dosage, and form as a medicine that had already obtained such marketing authorisation, and if the imported medicine was “competitive in relation to the price of the medicinal product which has obtained authorisation.”

One obvious reason behind the competitiveness provision in the law was cost – to allow the Polish health service to save money on drugs by allowing it to import cheaper medicines than those already available in the country.

Despite acknowledging Poland’s right to run its health service as it saw fit, the European Commission – which monitors how EU countries adhere to EU law – challenged the Polish law as illegal in June of 2008. The commission requested the country to delete the competitiveness provision from its Law on Medicinal Products to come within the terms of the EU Directive on the Community Code Relating to Medicinal Products for Human Use. After protracted negotiations, the Polish government ultimately refused to back down, and the commission sued the Polish Government in the European Court of Justice in April of 2010 to compel the country to comply with the Medicinal Products Directive.

In its lawsuit, the commission argued that the Polish law conflicted directly with the Medicinal Products Directive because the directive provides that no medicinal product may be placed on the market in an EU country unless a marketing authorisation has been issued either by the medicines agency of that particular EU country or by the European Medicines Agency. The only exception to the directive arises where a doctor made a specific request to prescribe a drug for a particular patient for clinical reasons but where the drug was unavailable in that EU country.

In that regard, the Medicinal Products Directive specifically stated that an EU country may exclude from the provisions of the directive “medicinal products supplied in response to a bona fide unsolicited order, formulated in accordance with the specifications of an authorised healthcare professional and for use by an individual patient under his direct personal responsibility.”

According to the commission, the exception to the Medicinal Products Directive did not include situations where the exception was granted because of the cost of the drug. The commission noted that the Polish law could allow any hospital or wholesaler in Poland to import unlimited quantities of unauthorised drugs on the basis of cost, and without any specific reference to the opinion of a specific doctor to the needs of a particular patient and unavailability of that medicine or other suitable medicine within Poland.

While acknowledging the influence of price on a decision to import and use such a drug, the Polish government was at pains to insist that the national law protected patient safety by including requirements that:n the intended medicine be certified as

necessary for the purpose of saving the life or safeguarding the health of a patient;

n the intended medicine was already properly marketed under the authorisation of the country from which it was imported;

nthe intended medicine was approved by a medical specialist in the medical sector concerned;

npharmacies, wholesalers and hospitals engaging in the commercial sale of those medicinal products maintain a register for that purpose;

nthe requirements governing safety of the intended medicine were satisfied like any other drugs authorised in Poland;

nno intended medicine would be allowed into Poland if its authorisation has already been rejected by Poland’s medicines agency. In its decision, handed down on March

29, the Court of Justice adopted the arguments of the commission and rejected those of the Polish government. The court wrote that “to exclude the application of the directive’s provisions can be exercised only if that is necessary, taking account of the specific needs of patients. A contrary interpretation would conflict with the aim of protecting public health, which is achieved through the harmonisation of provisions relating to medicinal products, particularly those relating to the marketing authorisation.”

'Special needs' The court added that the concept of “special needs” identified in the directive “applies only to individual situations justified by medical considerations and presupposes that the medicinal product is necessary to meet the needs of the patient. Also, the requirement that medicinal products are supplied in response to a ‘bona fide unsolicited order’ means that the medicinal product must have been prescribed by the doctor as a result of an actual examination of his patients and on the basis of purely therapeutic considerations.”

Further, the court ruled that allowing the exception provided for in the Directive relates only to extraordinary situations “in which the doctor considers that the state of health of his individual patients requires that a medicinal product be administered for which there is no authorised equivalent on the national market or which is unavailable on that market. Where medicinal products having the same active substances, the same dosage and the same form as those which the doctor providing treatment considers that he must prescribe to treat his patients are already authorised and available on the national market, there cannot in fact be a question of ‘special needs.’”

* For more details about the decision, European Commission -v- Government of Poland (C-185/10), visit the European Court of Justice website at www.curia.eu.

SAFETY OVER PRICECheaper drug costs cannot overrule EU law on authorised medicinesby Paul McGinn

36

From the Archive

New IOL puts bag inside lens to eradicate PCOby Ana Hidalga-Simon MD, PhD

Alicante - It looks weird, but promises to be very good. An innovative IOL designed by Marie-Jose Tassignon MD aims to eradicate PCO by putting the bag inside the lens.

Dr Tassignon, Antwerp, Belgium, started by reminding the audience at the annual meeting of the Mediterranean Ophthalmological Society that most artificial lenses have a higher refractive index than our natural lens, and therefore need to be thinner. Optically that results in a lens with less fine line resolution.

"We are all very familiar with the importance of knowing the refractive index of a lens for power calculations before implantation. The thinner the lens the more foldable it would be, but that is associated with a high refractive index and low line resolution. The use of thicker, less foldable lenses should not then be seen as a completely disadvantageous move," she said.

* From EuroTimes Volume 7 Issue 2 July 2002

Keramed distribution rightsZiemer Ophthalmic Systems AG has announced that it has obtained exclusive rights for distribution in Germany, Switzerland and Austria of the KeraKlear artificial cornea and the EndoInjector from Keramed Inc, Sunnyvale, California.

The KeraKlear Artificial Cornea is a medical device for the treatment of corneal blindness which can be implanted in the eye through a very small incision. The EndoInjector (previously known as the EndoShield) is the latest generation device to enable delivery of a corneal graft for Descemet’s Stripping Endothelial Keratoplasty (DSEK).

“The KeraKlear Artificial Cornea and EndoInjector have CE approval. No regulatory clearance is available for either product in the US. Market introduction of both products in Germany, Switzerland and Austria is scheduled for autumn 2012,” said a company spokeswoman.n www.ziemergroup.com

Precision Laser SystemOptiMedica Corp. has announced that its Catalys Precision Laser System has been CE mark approved for creating single-plane and multi-plane arc cuts/incisions in the cornea during cataract surgery.

“The CE mark approval for corneal incisions is an exciting development that will allow Catalys to bring even more value to the laser cataract procedure,” said Mark J Forchette, OptiMedica president and chief executive officer. n www.optimedica.com

37

EUROTIMES | Volume 17 | Issue 7/8

International aid projectsGeuder is supporting ophthalmological aid projects in third world countries with instruments and equipment systems with a project known as The Platform, a joint project of Geuder and the German Committee for the Prevention of Blindness.

"For this purpose, the company collects used, but fully functional, ophthalmic surgery equipment," said a company spokeswoman. "Donors are companies, ophthalmic hospitals and practices from all over Germany. Geuder assesses and overhauls these product donations for imminent use abroad and provides its many years of repair and service know-how free of costs," she saidn www.geuder.com

Epithelium removalOrca Surgical has received the CE mark for their Epi-Clear™ dynamic epikeratome for use in epithelium removal. “Epi-Clear will be sold as a kit containing two ergonomic multiple-use stainless-steel handles and a disposable cassette dispenser with two multi-blade sterile tips,” said a company spokesman.

“Each cassette is intended for single use for both eyes. The ergonomically designed hand piece will greatly increase ease-of-use for physicians performing the treatments,” he said. n www.orcasurgical.com

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Feature

indUstry neWsRecent developments in the vision care industry

Two model versionsThe OCULUS Easyfield® perimeter is now available in two distinct model versions: Easyfield® C (“C” for “Comfort”, with Chinrest) and Easyfield® S (“S” for “Standard”).

“Keeping the measurement principle unaltered, the changes are aimed to improve the quality of the performed visual field tests and to keep up to date with advances in computer technology,” said a company spokeswoman.

“Despite its small size, the new Easyfield® C/Easyfield® S is a full-fledged perimeter, capable of performing standard automated perimetry of the central visual field up to 30° eccentricity. It is equipped with a stylish, vertically adjustable double chinrest, perfectly adapted to the award-winning design of the ergonomically movable perimeter cone. This versatile solution allows more comfortable tests (even for elderly patients) and therefore more reliable test results,” according to Oculus.n www.oculus.de

Optical biometerNIDEK has received the CE mark for the Optical Biometer AL-Scan. “In 10 seconds the AL-Scan measures six required values for IOL calculation including axial length, corneal curvature radius, anterior chamber depth, central corneal thickness, white-to-white distance and pupil size,” said a company spokesman.

“To facilitate easy acquisition, NIDEK has incorporated 3-D auto tracking and auto shot. Proprietary measurement algorithms enhance the signal-to-noise ratio by decreasing noise and boosting the signal, enabling the AL-Scan to measure eyes with even dense cataract. For extremely dense cataracts, the AL-Scan has an optional built-in ultrasound biometer, allowing measurement of virtually any cataractous eye,” he said.

Where do you go for questions on:• Fluid in interface years after LASIK• Loose zonules• MRSA endophthalmitis• Prevention of epithelial ingrowth with flap lifts• IOL target for captured optic

These are just some of the hundreds of everyday issues and questions ASCRS members discuss on eyeCONNECT. It’s where members tap into the awesome knowledge base of the ASCRS community for quick answers to pressing problems. eyeCONNECT gives members the assurance that they’re making the best choices possible. And it’s available only through ASCRS – the ONE society focusing exclusively on cataract and refractive surgery.

The power of the ASCRS community. Can you afford to practice without it?

• Late onset corneal haze after PRK• YAG capsulotomy in the ASC

EyeCONNECTLogin

Subscribe to ASCRS’ eyeCONNECT today andconnect with colleagues in a worldwide virtual community.

Visit www.eyeCONNECTIONS.org and click the Discussions tab.Login (using the same user name andpassword as for the ASCRS website), click “My Subscriptions,” choose the list(s)you wish to subscribe to, the deliverymethod, and click “save.”

Not yet a member of ASCRS? Visit www.ASCRS.organd join online today.

Click the “Membership” tab.

EUROTIMES_July 2012 ads_Layout 1 6/11/12 1:36 PM Page 2

39

EUROTIMES | Volume 17 | Issue 7/8

Subclinical macular oedema post-cataractSubclinical macular oedema after uneventful phacoemulsification is a poorly understood issue of growing concern. A new optical coherence tomography (OCT) study indicates post-oedema is associated with changes in the outer nuclear layer of the retina, comprising the photoreceptors. Moreover, it appears that the incidence of the problem may be lower when using a femtosecond laser-assisted surgical approach. Researchers evaluated and compared thickness changes in the retinal layers in the macula with OCT segmentation software after femtosecond laser-assisted phacoemulsification and conventional phacoemulsification in a small study comprising 25 eyes of 25 patients. There was no significant difference between the two groups in terms of age, sex, refractive errors, phaco time or axial length. The study revealed statistically significant differences in absolute outer nuclear layer thickness and relative outer nuclear layer thickness in the inner and outer macular rings between the two groups. After adjusting for effective phaco time in multivariate modelling, type of surgery showed a significantly lower relative outer nuclear layer ratio in the inner retinal ring and in the outer retinal ring. After femtosecond laser-assisted cataract extraction, subclinical macular thickening, which was most prominent four to eight weeks after surgery, was delayed and less than with the standard ultrasound technique. The researchers note that femtosecond laser-assisted cataract surgery may provide an option for less traumatic cataract extraction, and could prove especially important in the treatment of patients with diabetes and diabetic retinopathy or even in patients with uveitis. n Z Nagy et al., JCRS, “Macular morphology

assessed by optical coherence tomography image segmentation after femtosecond laser-assisted and standard cataract surgery”, Volume 38, Issue 6, 941-946

Multifocal IOL vs. single optic accommodating IOLSpanish investigators compared visual outcomes and intraocular optical quality in patients receiving a new low-addition power multifocal refractive IOL with rotational asymmetry (Lentis-Mplus LS-312 MF15) and a single-optic accommodating IOL (Crystalens HD). The study included 66 eyes in 40 patients. Postoperatively, both groups had a significant improvement in the uncorrected and corrected distance visual acuities and uncorrected and corrected

near visual acuities. Distance-corrected near visual acuity was significantly better in the multifocal group postoperatively. No significant differences in UNVA and CNVA were detected postoperatively. In the defocus curve, the multifocal group had significantly better visual acuities at several defocus levels. The accommodating group had better contrast sensitivity under photopic conditions at all spatial frequencies. The multifocal group had significantly higher postoperative intraocular tilt. The researchers conclude that while both IOLs restored distance vision, the refractive multifocal IOL provided better near visual rehabilitation.nJ Alió et al., JCRS, “Visual outcomes with

a single-optic accommodating intraocular lens and a low-addition-power rotational asymmetric multifocal intraocular lens”, Volume 38, Issue 6, 978-985.

Refractive laser in thin corneasMany surgeons consider a preoperative central corneal thickness greater than 500 μm to be the cut-off value for laser refractive surgery, although some have achieved good results in eyes with a cornea thinner than 500 μm. A new study reviewed the medical records of nearly 200,000 cases, comparing long-term refractive and visual outcomes of LASIK and laser surface ablation in eyes with corneas thinner than 470 μm. The final study sample comprised 128 eyes of 84 patients (LASIK, 40 eyes; LASEK, 84 eyes; PRK, 4 eyes). Both techniques were effective, safe and predictable in eyes with corneas thinner than 470 μm, normal preoperative topography, and a residual corneal bed thickness greater than 250 μm.nM Reza et al, JCRS, “Long-term comparison

of laser in situ keratomileusis versus laser surface ablation in corneas thinner than 470 μm”, Volume 38, Issue 6, 1034-1042.

Review

Jcrs hiGhLiGhtsJournal of Cataract and Refractive Surgery

Thomas Kohnenassociate editor of jcrs

FURTHER STUDYBecome a member of ESCRS to receive a copy of EuroTimes and JCRS journal

CONTROVERSIES IN CATARACTAND REFRACTIVE SURGERY 2012

Sunday, September 9, 2012

14.00–16.00

Intraoperative Aberrometry: Of Value or Not Proven?Stephen S. Lane, MD, Paul-Rolf Preussner, MD, PhD

Pediatric Refractive Surgery:LVC or pIOL?William F. Astle, MD, FRCS,Michael O’Keefe, FRCOphth, MD

Femtosecond Cataract Surgery Outcomes:An Advance or Not?H. Burkhard Dick, MD, PhD,Steve A. Arshinoff, MD, FRCSC

Chairs: Emanuel S. Rosen, MD, FRCSEd,Thomas Kohnen, MD, PhD, FEBO

JCRS Symposium

During the XXX Congress of the ESCRS, Milan, Italy

Reference

caLendar oF eVentsDates for your Diary

Advertising Directory: A.R.C. Laser Ag: Pages: 9, 26; Abbott Medical Optics: Pages: 3, IBC; Acufocus: Pages: 16, 35; Alcon Laboratories: Pages: 11, OBC; Angiotech: Page: 19; Alsanza Medizintechnik und Pharma GmbH: Page: 33; ASCRS / Eyeworld: Pages: 23, 29, 38; Croma-Pharma: Pages: 8, 13; D.O.R.C. International BV: Page: 20; Haag Streit International: Page: 18; iCare: Page: 10; NIDEK: Page: 27; Oertli Instruments Ag: Page: IFC; Technolas Perfect Vision: Page: 32; Thrombogenics: Page: 7; VSY Biotechnology: Page: 15; Ziemer Ophthalmic Systems: Page: 24

July September

April

November

November

September

JuneFebruary

September October

October OctoberOctober

October

September September 2012 2012

2013

2012

2012

2012

20132013

2012 2012

2012 20122012

2012

2012 2012

ISER 2012XX Biennial Meeting of the International Society for Eye Research22-27 BERLIN,GERMANYwww2.kenes.com/iser/pages/home.aspx

3rd EuCornea Congress6-8 MILAN, ITALYwww.eucornea.org

ASCRS•ASOASymposium & Congress19-23 SAN FRANCISCO, CA, USAwww.ascrs.org

AAO•APAO Joint Meeting10-13 CHICAGO, IL, USAwww.aao.org

19th Annual Scientifi c Meeting of the MCLOSA and Regional Scientifi c Meeting of the IOSS30 LONDON, UKwww.mclosa.org.uk/annualmtg.html

2nd Th essaloniki International Vitreo-Retinal Summer School14-16 CHALKIDIKI, GREECE

European Society of Ophthalmology (SOE) 20138-11 COPENHAGAN, DENMARKwww.soe2013.org

17th ESCRS Winter Meeting15-17 WARSAW, POLANDwww.escrs.org

UKISCRS – XXXVI Annual Congress27-28 BRIGHTON, UKwww.ukiscrs.org.uk

8th Annual Congress of the Croatian Society for Cataract and Refractive Surgery5-7 DUBROVNIK, CROATIAwww.cscrs.hr

EVER 2012 Congress10-13 NICE, FRANCEwww.ever.be

8th International Symposium on Uveitis19-22 HALKIDIKI, GREECEwww.ISU2012.org

Modern Technologies in Cataract and Refractive Surgery – 201225-27 MOSCOW, RUSSIAwww.mntk.ru

Practice Development Weekend5-7 DUBLIN, IRELANDwww.escrs.org/practice-development

VI Congress of the Latin American Society of Cataract and Refractive Surgeons4-6 BUENOS AIRES, ARGENTINAwww.congresos-rohr.com/alaccsar2012

12th EURETINA Congress6-9 MILAN, ITALYwww.euretina.org

2nd World Congress of Paediatric Ophthalmology and Strabismus7-9 MILAN, ITALYwww.wcpos.org

XXX Congress of the ESCRS8-12 MILAN, ITALYwww.escrs.org

40

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©2012 Abbott Medical Optics Inc. Advanced CustomVue, iLASIK, Star S4 IR, iDesign and the iDesign logo are trademarks owned by or licensed to Abbott Laboratories, its subsidiaries or affiliates. For outside the U.S. use only. 2011.12.09-RF4375

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