opthalmologi jurnal

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Endophthalmitis prophylaxis in cataract surgery:Overview of current practice patterns

in 9 European countries

Anders Behndig, MD, PhD, Beatrice Cochener, MD, PhD, Jose Luis Guell, MD, PhD,Laurent Kodjikian, MD, PhD, FEBO, Rita Mencucci, MD, PhD,

Rudy M.M.A. Nuijts, MD, PhD, Uwe Pleyer, MD, PhD, Paul Rosen, FRCS, FRCOphth,Jacek P. Szaflik, MD, PhD, Marie-Jose Tassignon, MD, PhD

Data on practice patterns for prophylaxis against infectious postoperative endophthalmitis (IPOE)during cataract surgery in 9 European countries were searched in national registers and reviews ofpublished surveys. Summary reports assessed each nations IPOE rates, nonantibiotic prophylac-tic routines, topical and intracameral antibiotic use, and coherence to the European Society of

Cataract & Refractive Surgeons (ESCRS) 2007 guidelines. Although the reliability and complete-ness of available data vary between countries, the results show that IPOE rates differ significantly.Asepsis routines with povidoneiodine and postoperative topical antibiotics are generally adopted.Use of preoperative and perioperative topical antibiotics as well as intracameral cefuroxime varieswidely between and within countries. Five years after publication of the ESCRS guidelines, there isno consensus on intracameral cefuroxime use. Major obstacles include legal barriers or persistingcontroversy about the scientific rationale for systematic intracameral cefuroxime use in somecountries and, until recently, lack of a commercially available preparation.

Financial Disclosure: Dr. Pleyer has received research funding from Bundesministerium furBildung und Forschung and Deutsche Forschungsgemeinschaft and has served as a consultantfor Abbott Medical Optics, Inc., Alcon Laboratories, Inc., Allergan, Inc., Bausch & Lomb, NovartisCorp., Santen, Inc., Laboratoires Thea, and Ursapharm Arzneimittel GmbH. Dr. Tassignon has a pro-

prietary interest in the bag-in-the-lens technique and intraocular lenses licensed to Morcher GmbH.No other author has a financial or proprietary interest in any material or method mentioned.

J Cataract Refract Surg 2013; 39:14211431 Q 2013 ASCRS and ESCRS

Cataract surgery is the most commonly performedsurgical procedure in many developed countries,13

and the frequency continues to increase, probablybecause of changes in population structure,4 technicaladvances with better outcomes, and an increasing pro-

portion of outpatient and second-eye procedures.5

Infectious postoperative endophthalmitis (IPOE) isthe most dreaded complication of cataract surgery.Infectious postoperative endophthalmitis has a devas-tating prognosis, with a visualoutcome of 20/200 orworse in 15% to 30% of cases.68 The severity andclinical course of IPOE depend on the virulence andthe number of inoculated pathogens, as well as thepatient's immune state and the time of diagnosis andtreatment.9,10 The most common pathogens remaingram-positive Staphylococcus epidermidis (orcoagulase-negative staphylococci [CNS]) andS aureus

(Table 1).

6,1016

Increasing resistance ofStaphylococcussp to a broadspectrum of antibiotics, including the latest fourth-generation fluoroquinolones, eg, methicillin-resistantS aureus (MRSA) and methicillin-resistant S epidermidis(MRSE), is currently a major concern.17,18 Fortunately,

IPOE is a rare complication. Reported IPOE frequencyvaries widely, but a systematic review has shown anoverall estimate of 0.128% between 1963 and 2003.2

Despite the low incidence rate, IPOE generates a sub-stantial healthcare burden because of the high numberof procedures performed and the severe consequencesof overt infections.

Various operative and nonoperative measures havebeen advocated to prevent this serious complica-tion.19,20 Preoperative antisepsis of the perioculararea with topical povidoneiodine is widely adoptedandisconsidered the basic standard of IPOE preven-

tion,

21

although chlorhexidine is preferred in some

Q2013 ASCRS and ESCRS

Published by Elsevier Inc.

0886-3350/$ - see front matter 1421http://dx.doi.org/10.1016/j.jcrs.2013.06.014

REVIEW/UPDATE
http://dx.doi.org/10.1016/j.jcrs.2013.06.014http://dx.doi.org/10.1016/j.jcrs.2013.06.014


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Table 2. Summary findings on current antibiotic prophylaxis for cataract surgery in 9 European countries.

Country

Number ofCataractSurgeriesper Year

IPOE IncidenceRate (Period)/

Origin of Source Data

Main Guidelinesfor AntibioticProphylaxis

IC CefuroximeProphylaxis AdoptionRates/Specific Factors

Favoring or Limiting UseTopical Antibiotic

Prophylaxis

SwedenA 91000 !0.04% (19922009)

!0.02% (2012)

National Cataract

Registry;

Swedish Ophthalmological

Society

90% (2012) Not recommended

and no routine use

except RLE or high-

risk patients

National registry33

(coveringO98%

of procedures)*

Omission of IC

antibiotics considered

unethical

FranceB,C 630000 0,21%0.32% (19922002)

0.03%0.06% (20072011)

National Agency for

Health Products

Safety (AFSSAPS)18

!5% (2006)

40% (2011)

Preoperative: 28%

(2007)36, currently

not recommended

National registry14

(non-mandatory reporting);

limited surveys)12,34,32

Recommended by

regulatory national

guidelines since 201118

Per-/post-operative:

95%(2007)36, currently

recommended

UnitedKingdomD

O330000 0.03%0.20% (19972006) Scottish IntercollegiateGuidelines Network49;

Royal College of

Ophthalmologists50

10% (2005)23

45%-61%

(2009-2010)19,45,48

Preoperative:6%-9% (2005)23

Multiple, often large

surveys7,13,19,20,23,37-45Historically, the

subconjunctival route

was the preferred choice23

Per-/post-operative:

90% (2005)23

SpainE 200000 0.48%/0.50%

0.056%/0.11% (1999-2008)

ESCRS guidelines10 Not known Preoperative:

variable15,31

Single-centre surveys15,24,31 Per-/post-operative:

100%15,24,31

GermanyF 700000 0.15% (1999)

0.060.07% (20062011)

ESCRS guidelines10 Not known,

probably!20%

Pre- and per-/

post-operative:100%

Multicenter or single-

center surveys25,51,52Opposed by legal issues

BelgiumG 120 000 0.036%

(20092011)

ESCRS guidelines10 Not known Not known

Extrapolated from the

EUREQUO registry5Implementation of

ESCRS guidelines

started in 2009

ItalyH 350 000 0.05%0.35% ESCRS guidelines10 20% (2010)53 Preoperative: 76%,

Peroperative: 40%

Postoperative: 100% 53

Extrapolated from the

ESCRS trial4Implementation of

ESCRS guidelines started

in 2008

NetherlandsI,J

140 0 00 0.03% (2012) Dutch OphthalmologicalSociety

27% (2010) Pre- and per-/post-operative:

100%

National registry

(mandatory

outcome reporting)

Recommended in

high-risk patients only

PolandK O160000 0.29%*(2004)55

Current rate not known

Polish Society of

Ophthalmologists

Not known,probably

not used in most cases

Not known

Off-label use, complex

preparation

ESCRSZEuropean Societyof Cataract & Refractive Surgeons; ICZ intracameral; IPOEZ infectious postoperative endophthalmitis; RLEZ refractivelens exchange

Italics: yet unpublished, extrapolated or estimated figuresAKAdditional information from personal communications (2012) or from conference proceedings (see list in Other Cited Material).

*This figure may have included cases of toxic anterior segment syndrome.

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J CATARACT REFRACT SURG - VOL 39, SEPTEMBER 2013


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antibiotics is uncommon, but fluoroquinolones may be usedin refractive lens exchange and in high-risk patients. The rateof IPOE was lower from 1999 to 2009 than in 1998, and ana-lyses clearly showed that this was attributable to generalizedintracameral cefuroxime use.

There are no formal national guidelines, but there areinformal recommendations from the National Cataract

Registry and the Swedish Ophthalmological Society.

France

In France, national guidelines on intracameral cefuroximewere recently released by the Health Ministry-governedregulatory Agence Francaise de Securite Sanitaire desProduits de Sante,18 a unique feature among the 9 reviewedcountries. About 630 000 cataract procedures are performedeach year by 706cataract centers (237 public hospitals, 469private clinics).B Endophthalmitis reporting to the nationalregister (Observatoire National Des Endophtalmies)14 isnot mandatory. Historical epidemiological studies have re-ported various incidence rates over timed0.32% in 1992,12

0.21% during the 2000 to 2002 period34d but the true currentrate is not known.

Patients' infection risk assessments and antiseptic showersand shampoos (povidoneiodine the day before and themorning before surgery) are routinely performed. Recom-mended antiseptic preparation of the operative site is basedon povidoneiodine applied 3 times (10% on skin duringdilation, 5% on skin and eye in the anesthesia room, 5%into conjunctival sac on the operating table). Moreover, anti-sepsis duration should be timed with a stopwatch (2 minutesat each step). These measures must be associated with apatient-selection process to identify infected and high-riskpatients, as well as hygiene measures in the operatingroomapplicable to staff, equipment, and the environment.18

Topical antibiotics are not recommended before cataractsurgery. The national guidelines emphasize that because oftheir high selective power, topical fluoroquinolones shouldbe reserved for curative treatment of severe eye infection.18

However, postoperative topical antibiotic prophylaxis isrecommended during 1 week and should target commonIPOE-causative bacteria, ie, gram-positive cocci.18,35 Cefur-oxime (1.0 mg/0.1 mL) intracameral injection at the end ofthe procedure is a strongly recommended antibiotic prophy-laxisin the absence of any contraindication to cephalospo-rins.18 The drug is usually prepared by the center's localpharmacy. Subconjunctival injections and antibiotic prophy-laxis added to the irrigation fluid are not recommended.When cephalosporin administration is contraindicated orin patients at risk, the national guidelines recommend oral

levofloxacin (500 mg the day before and 500 mg on the dayof surgery). In general, at-risk patients are those withdiabetes mellitus, previous implantation of an intraoculardevice other than for cataract surgery, and previous postop-erative endophthalmitis in the fellow eye; for cataractsurgery only, cited risk factors are intracapsular extractionand secondary implantation. In cases of capsule rupturein patients who did not receive a preoperative systemicantibiotic, perioperative intravenous levofloxacin isrecommended.18

According to a prospective longitudinal multicenterobservational study that enrolled 781 patients fromSeptember 2007 to February 2008 before the ESCRS study,28.5% of patients received preoperative topical antibioticprophylaxis and 94.7% received postoperative topical

combined antibiotic plus steroid drops.36 A recent reportfrom 2 large centers covering 3316 patients during a 2-yearperiod (January 2007 to December 2008) showed a 0.06%IPOE rate after the implementation of systematic intracam-eral cefuroxime injections.32 A recent survey showed thatthe use of intracameral antibiotics (cefuroxime in 60% to73% of cases) dramatically increased from 2006 to 2011

(from 7% to 61%, respectively).C This trend is expected toincrease in future years because of the publication of thenational guidelines in 2011.

United Kingdom

Data on IPOE epidemiology and practice patterns in theU.K. are fairly well known fromthe large series of reportspublished over the past decade.7,13,19,20,23,3744 Accordingto a recent survey by the Royal National Institute of BlindPeople, the number of cataract operations reached 350 602in 2010 but fell to 338565 in 2011 because of cost-cuttingmeasures.D The baseline IPOE rate reported in the BritishOphthalmological Surveillance Unit study was 1/700 cata-

ract surgeries (0.14%); it was also estimated that only 62%of IPOE cases were reported.7 A 2009 review by Carrimet al.13 found that published IPOE rates during the 1997 to2006 period (observed at single-unit, regional, or nationallevel) varied from 0.03% to 0.2%.7,13,3740

According to 4 surveys of ophthalmologists' practices,subconjunctival antibiotics, predominantly cefuroxime,were administered at the end of surgery in 68% to 82% ofcases comparedwith intracameral antibiotics in only 10%to 16% of cases.7,23,42,43 Some clinicians have argued thatthere is no evidence that a change from subconjunctival tointracameral cefuroxime would be more effective.45,46 Latersurveys have shown a strong shift toward the use ofintracameral cefuroxime, with 44.7% to 61.0% of surgeonspreferring the intracameral administration route.19,44,47 A

single-center retrospective analysis of 36 743 phacoemulsifi-cation procedures reported that intracameral cefuroximewas a safe alternative to subconjunctival cefuroxime with asignificantly lower rate of IPOE (subconjunctival versus in-tracameral route: OR, 3.01; 95% CI, 1.37-6.63).20

Regarding practice guidelines, intracameral antibioticprophylaxis is recommended for cataract surgery by theScottish Intercollegiate Guidelines Network48 whereas theRoyal College of Ophthalmologists49 leaves the details ofantibiotic use to the surgeon's discretion.

Spain

There is no national register for cataract surgery or IPOEin Spain, but some centers have developed their own local

observational databases, allowing estimates of IPOE ratesbased on single-center samples: for instance, no cases ofIPOE were observed among the 1151 cataract surgery proce-dures performed in 2011 at Barcelona's Instituto de Micro-ciruga Ocular, with cefuroxime intracameral injections inall cases.E About 200 000 cataract procedures are performedeach year.E

The following protocol, based on the ESCRS 2007 guide-lines, is used very commonly in private and public Spanishinstitutions: preoperative prophylaxis combining lid hy-giene (scrubs with baby shampoo), topical antibiotics, andpovidoneiodine 10% solution applied on the skin beforethe patient enters the operating room, then again beforestarting surgery (5-minute wait), combined with a povi-doneiodine 5% solution into the conjunctival sac. In case

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of allergy, povidoneiodine is replaced by a chlorhexidine0.05% solution. Topical antibiotics (ofloxacin 0.3%) areused both before surgery (1 drop 3 times a day for 3 days)and after surgery (1 drop 4 times a day for 1 week).E

A retrospective survey from the University HospitalFundacion Alcorcon (Madrid) covering a 10-year period(1999 to 2008)showed a mean IPOE rate of 0.30% (95% CI,

0.26%-0.35%),24 with a significant difference in mean ratesbefore and after the implementation of cefuroxime (1999 to2005: 8099 patients, 0.48% IPOE rate; 2005 to 2008: 7074 pa-tients, 0.056% rate; relative risk 0.12 [0.04-0.33], ie, a nearly9-fold risk reduction).15 In case of a beta-lactam antibioticallergy, intracameral vancomycin (0.1 mg/0.1 mL) wasused. In another retrospective study covering 4281 cataractsurgeries,31 the IPOE rate dropped from 0.5% to 0.11% afterthe implementation of cefuroxime.

Germany

According to the results of an annual survey by theDeutschsprachige Gesellschaft fur Intraokularlinsen-Implantation, Interventionelle und Refraktive Chirurgieand Deutsche Ophthalmologische Gesellschaft (DGII/DOG) involving all major centers and encompassing halfof all cataract surgery procedures, about 700000 cataract sur-geries are performed each year in Germany, 75% of whichare done in private office settings.F There is no nationalregister, but data are available from the DGII/DOG jointcommittee questionnaire.

Much about German practices was learned from the re-sults of a cross-sectional anonymous survey published in1999 by Schmitz et al.25 that analyzed 311 surgical centers(67% answer rate) and reported data on 340 633 cataract sur-geries performed in 1996. The survey found a mean IPOErate of 0.148% and provided a comprehensive picture of pro-

phylactic treatments used at that time. The use of intraocularantibiotics (60% of the respondents) was associated with asignificantly lower incidence of IPOE in both univariateand multivariate analyses (OR, 0.65; 95% CI, 0.43-0.98).However, in more than 90% of cases, the intraocular antibi-otics were added to the irrigating solution; intracameral in-

jection was used in only 5% of cases. Aminoglycosideantibiotics were used in 85% of cases, vancomycin in 7%,and a combination of vancomycin and aminoglycoside in5%. The application of povidoneiodine (68% of respon-dents) to the conjunctiva was also associated with a signi-ficantly decreased risk for IPOE (OR, 0.59; 95% CI,0.36-0.99). However, the use of preoperative topical antibi-otics was associated with a significantly increased risk (OR,2.38; 95% CI, 1.21-4.68), and a comparable trend was found

with topical antibiotic use after surgery (OR, 1.3; 95% CI,0.87-1.92).25 A later and comparable survey involving 538centers and more than 400 000 cataract procedures found a0.072% IPOE overall rate.50

Currently, povidoneiodine 5% is usually applied on theocular surface during 5C 5 minutes. Various topical antibi-otics (quinolones, aminoglycosides) are applied before, dur-ing, and after the procedure for 1 to 4 weeks.F A recentlypublished single-center retrospective survey includingmore than 26500 procedures found a 0.06% IPOE ratewhen prophylaxis was based on topical povidoneiodineand gentamicin-containing irrigation fluid administeredpreoperatively.51

Use of intracameral cefuroxime commenced after the pub-lication of the ESCRS 2007 guidelines. Intracameral

cefuroxime is currently used in an unknown proportion ofprocedures, probably fewer than 20%, because specific legalissues oppose this practice. There are no national IPOE pre-vention guidelines, but German ophthalmologists tend tofollow the ESCRS 2007 recommendations.

BelgiumThe estimatedannual number of cataract surgery proce-

dures is 120 000.G The number of active centers is unknown.Belgium does not have a mandatory registry of postopera-tive complications after cataract surgery, thus current figuresare not known. However, IPOE incidence at the AntwerpUniversity Hospital is 0.0% since the voluntary registry ofthe cataract surgeries performed at this center in theEuropean Registry for Quality Outcomes of Cataract andRefractive SurgeryG (partner countries: Austria, Belgium,Denmark, Finland, Greece, Germany, Hungary, Ireland,Italy, the Netherlands, Norway, Slovakia, Spain, Sweden,Turkey, and U.K.).5

Only limited information about current national practice

trends is available, but implementation of the ESCRSendophthalmitis guidelines started in 2009. No endophthal-mitis occurred during the past 2 years at the AntwerpUniversity Hospital where this protocol is routinely used.G

Regarding other routine prophylactic measures, patientsare checked before surgery for infection and povidoneiodine (5% on ocular surface, 10% on skin over 3 minutes)is used as an antiseptic without prior shower and no pre-operative topical antibiotics. Hygiene rules at the operationare focused on a standardized protocol for sterile draping.Topical antibiotics, mainly quinolones, are used duringand after surgery, according to licensed doses. Cefuroxime(1.0 mg/0.1 mL intracameral route or during incision hydra-tion) is used in 100% of cataract surgery procedures, accord-ing to the ESCRS 2007 guidelines.

Italy

A large but unknown number of Italian cataract centersperform an estimated 300 000 to 400 000 cataract surgery pro-cedures per year.H Although there is no national register, theincidence of IPOE has been estimatedto be 0.05% to 0.35%,ie, similar to other European figures.4

Prophylactic measures usually start with the screening ofhigh-risk patients for local risks (blepharitis, dacryocystitis,severe dry eye), systemic comorbidities (diabetes mellitus,immunosuppression, pulmonary infections, sustained anti-biotic/steroid therapy), and very high age (O85 years old).The reported data are the result of a survey conducted in2010 by the Italian Association of Cataract and Refractive

Surgeons. An eyelid cleaning is advised during the weekbefore surgery. Antiseptics are used in 100% of the proce-dures, mainly povidoneiodine (10% on periocular skin,5% on ocular surface [conjunctival fornix] applied for at least3 minutes) or chlorhexidine 0.05% in case of povidoneiodine allergy. Routine hygiene and draping rules andsingle-dose eyedrops are used. A wide-spectrum topicalantibiotic (aminoglycosides, fluoroquinolones) is usedduring the preoperative phase in 76% of cases,52 during theprocedure in 41%, and postoperatively in all patients.

Intracameral antibiotics have been used since 2008,following the ESCRS 2007 guidelines and legal aspects.Currently, either cefuroxime (1.0 mg/0.1 mL; 52%) or vanco-mycin (48%) is used in 41% of procedures.52 Syringes areprepared by local pharmacies. Since there are no specific




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national guidelines, Italian surgeons tend to follow theESCRS 2007 recommendations, but the reference source ismainly surgeon-dependent.

The Netherlands

In the Netherlands, 140 000 cataract surgery procedures

are performed each year, 80% in general hospitals, 12% in ac-ademic hospitals, and 8% within an increasing number ofambulatory surgery centers with multiple facilities.I

Outcome registration is mandatory for all surgeons, as re-quested by the Dutch Ophthalmological Society and theNetherlands IntraOcular Implant Club. According to thesedatabases, the IPOE rate is 0.03%.J

Povidoneiodine eyedrops in a concentration varyingfrom 0.3% to 5.0% are instilled preoperatively (0.3% is avail-able as a commercial preparation for topical use), and thenpovidoneiodine 5% to 10% is applied on the skin anddiluted solution (dilution according to surgeon's preference)on the ocular surface for 0.5 to 3.0 min. Class 1 hygiene rulesare applied to the operating room.53 Topical antibiotics are

often used before, during, and after the procedure; adminis-trations and dosages vary. Use of intracameral antibioticsstarted in 2007 after the publication of the ESCRS 2007 guide-lines and was used in approximately 27% of procedures in2010.J Syringes are prepared at the hospital's pharmacy.

In the absence of specific guidelines from national healthauthorities and on the basis of the low endophthalmitisrate of 0.03% in the Netherlands, the Dutch Ophthalmolog-ical Society recommends cefuroxime in high-risk cases only(capsule breaks, clear cornea incisions). Systematic use isconsidered debatable.

A retrospective review of all consecutive patients treatedfor acute IPOE after cataract surgery (N Z 250)ina singlecenter from 1996 to 2006 was recently published.16 Bacterialcultures (250 cases) showed bacterial growth in 66.4% of

cases. Of these, 53.6% revealed gram-positive CNS, 38.0%other gram-positive bacteria, 6.0% gram-negative patho-gens, and 2.4% polymicrobial cultures.

Poland

According to the national health insurance refunding sys-tem, 152 000 cataract surgery procedures were performed inPoland in 2011. About 15 000 to 20 000 additional cataractsurgeries are performed in private practices, although theirexact number is not known.K No reliable data on currentIPOE incidence rates are available. A survey published in2004 assessed data from 53 ophthalmology centers inPoland, involving 28 674 cases of routine cataract surgery,6518 cases of complicated cataract surgery, 1387 cases of

combined cataract and glaucoma surgery, and 2978 casesof glaucoma surgery. The prevalence of IPOE in this groupof patients ranged from 0.29% after cataract surgery to0.93% after complex surgery (cataract and glaucoma).54

These high incidence rates were interpreted as possible selec-tion bias due to the small size of the study sample. In addi-tion, IPOE was not proven by culture or polymerase chainreaction so some cases of toxic anterior segment syndromemight have been included.

In the absence of an accurate national observational data-base, the following information applies to the protocol usedin a single center in Warsaw onlyK: Prophylactic measuresinclude patient selection, antiseptic showers before surgery,and systematic povidoneiodine 5% antisepsis on the ocularsurface for 1 to 3 min. Routine sterile environment is

respected in the operating room. Topical antibiotics areapplied before, during, and after surgery. The drug of choiceis levofloxacin, and the administration schedule is 1 droptwice daily the day before surgery, 1 drop before surgery,1 drop during and the night after surgery, 1 drop 4 times aday for 2 weeks after surgery. In high-risk patients (blephar-itis, complicated cases), the postoperative dosage is

increased to 1 drop every 2 hours on the day of surgery.Although no hard data are available, intracameral antibi-

otics are probably not injected in most procedures because ofoff-label use and complex preparation.K However, cefurox-ime (1.0 mg/0.1 mL) has been used in 100% of the proce-dures in the Warsaw center since 2005; until 2012, thepreparation was outsourced to a commercial pharmacy,but currently syringes are prepared in the operating room.

Specific national guidelines have been prepared and arenow in the process of being approved. The Polish Societyof Ophthalmologists' recommendations are similar to theESCRS 2007 guidelines.

DISCUSSION

We found that the current practice patterns for IPOEprophylaxis between European countries differ signi-ficantly and often diverge from the antibiotic prophy-laxis practices recommended by the ESCRS guidelines.The data reported in the present overview come fromheterogeneous sources: Swedish data are based on anational register with a high coverage; Dutch IPOErates are based on a mandatory outcome reportingand practice trends; IPOE rates in the U.K. weredescribed by a series of dedicated surveys; in some

other countries, data about the volume of cataract sur-geries, IPOE prophylaxis practice patterns, and IPOEincidence rates are more or less unknown because anadequate national epidemiological system does notexist. Between these extremes, a variable amount ofreliable data documents exists in the remainingcountries.

While acknowledging that the variability of sourcedata limits our study's value, we believe that this lim-itation is not specific to this review but rather reflectsthe lack of adequate epidemiologic tools and system-atic reporting in most countries. In addition, this over-

view can by no means determine whether differencesin practice patterns and hygiene routines are reflectedin the varying IPOE rates. One also has to consider apossible bias since centers participating in surveys orreporting systems may be more attentive to all stepsin the processes of patient preparation and surgicalprocedures. Thus, the present overview does not pre-tend to report actual practice patterns and epidemio-logical facts in the reviewed countries or to provideanswers to why the IPOE rates differ, but it probablyoffers a fair picture of the current status in this field.It also helps to explain why the ESCRS guidelines

are not yet consistently adopted in these countries.




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Practice patterns for general hygiene rules in theoperating room and systematic preoperative antisep-sis with povidoneiodine or chlorhexidine tend toconverge. The use of preoperative antisepsis with po-vidoneiodine (5% solution on the conjunctiva andcornea and 5% to 10% solution on the periorbitalarea for R3 min) is based on a microbiological andclinical rationale since it has been shown to diminishthe bacterial load and prevent IPOE.21,25,5558 Its useis recommended by current guidelines.10,17,18 If povi-doneiodine is contraindicated, chlorhexidine 0.05%is an alternative.10,18,59 The use of chlorhexidine as aprimary antisepsis agent in Swedenhas proven effi-cient and safe over a long period.33,60

Regarding antibiotic prophylaxis regimens, data oflandmark importance came out of the ESCRS random-ized trial, which comprised 16603 patients andcompared (1) intracameral cefuroxime (1.0 mg/0.1 mL)

bolus injections at the end of cataract surgery withno intracameral cefuroxime and (2) topical periopera-tive levofloxacin 0.5% eyedrops with no perioperativetopical levofloxacin. Topical levofloxacin was given inall groups postoperatively. The results showed anearly 5-fold decrease in the risk for presumed andproven IPOE when intracameral cefuroxime wasincluded.4 The effect of topical perioperative levoflox-acin was not significant. The incidence rates were0.345% for total IPOE and 0.247% for proven IPOE inthe group with placebo drops and no intracameral ce-furoxime, which may be regarded as the true current

background rates of IPOE after phacoemulsificationin Europe in the absence of antibiotic prophylaxis.4

Our overview shows that postoperative topical anti-biotic prophylaxis is also commonly used in all coun-tries (except Sweden), particularly in clear cornealincision surgery, for up to 2 weeks.10,18 Its efficacy,however, is not proven or only weakly proven byretrospective studies.61,62 In the ESCRS study, levo-floxacin was administered to all groups postopera-tively. According to the authors, the relatively highincidence rates of IPOE in subgroups without intra-cameral cefuroxime suggested that postoperative lev-

ofloxacin alone conferred little benefit. An alternativeexplanation is that had this type of antibiotic prophy-laxis not been used, the rates across all groups wouldhave been higher.4

Much wider variation in preoperative and perioper-ative topical antibiotic prophylaxis regimens, as wellas intracameral cefuroxime, is observed in thisoverview. The ESCRS study has not assessed the roleof preoperative topical antibiotic prophylaxis. A previ-ous systematic review concluded that its efficacy wasnot yet scientifically proven.21 Thus, the ESCRS 2007guidelines cite preoperative topical antibiotic prophy-

laxis as an option to consider,

10

while the French 2011

guidelines do not recommend it.18 Subconjunctivalantibiotic prophylaxis has also been used over thepast 30 years, particularly in the U.K. However, onthe basis of available data, the ESCRS guidelines statedthat it probably has little prophylactic effect on the pre-vention of IPOE9,10,21 andthe French 2011 guidelinesdo not recommend its use.18

Intracameral cefuroxime is recommended by ESCRSand French guidelines,11,13 by the Scottish Intercolle-giateGuidelines Network,48 and by Canadian guide-lines,63 while details of antibiotic use are left to theindividual surgeon's discretion by the Royal Collegeof Ophthalmologists49 and the American Academyof Ophthalmology.17

Ophthalmologists tend to follow the ESCRS recom-mendations for intracameral cefuroxime in manyEuropean countries lacking national guidelines, butlegal barriers may oppose its use. Controversy about

the scientific rationale for systematic intracameralcefuroxime persists in the U.K., where the subconjunc-tival route has been historically dominant and in theNetherlands where its use is limited to high-riskpatients. Generally, persisting controversies aboutthe scientific rationale for systematic use, legal bar-riers, and the lack of a commercially available prepara-tion appear to have conferred major practical barriersto intracameral cefuroxime's widespread use,18,44,64

although a commercially available product iscurrently being introduced.

Cefuroxime is a second-generation cephalosporin

that is effective against most bacteria that causeIPOE,26 in particular staphylococci and streptococci(except MRSA, MRSE, and Enterococcus faecalis). It isalso effective against gram-negative bacteria (exceptPseudomonas aeruginosa) and P acnes. Bactericidal ce-furoxime concentrations of 2742 mg/L are achievedwithin 30 seconds of intracameral injection and dropsto 756 mg/L 1 hour later.27 This was the rationale forestablishing the administration regimen still in use(1.0 mg/0.1 mL at the end of phacoemulsification cata-ract surgery before the wound is closed), which startedin Sweden 13 years ago.2730,33 The regimen has been

further supported by the ESCRS randomized trial re-sults4 and additional retrospective studies in France,Spain, and the U.K.20,24,31,32 Intracameral cefuroximehas been shown to have a good safety profile, withno evidence of increased endothelial cell loss or anyproof of increased bloodaqueous barrier distur-bance.28 The main disadvantage with cefuroximemay instead be the gaps in its antimicrobial spectrum.Notably, there is a striking convergence between thevery low IPOE rate in Sweden (!0.040%; 19922009),33 where intracameral cefuroxime is used in90% of cases, mostly without topical antibiotic pro-

phylaxis, and the equally low rate reported in the




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Netherlands (0.03%),J where topical antibiotics are thebasis of IPOE prophylaxis while intracameral cefurox-ime is used in only 27% of cases.

Considering the significant differences in IPOE ratesseen in scientific reports (including the ESCRSrandomized trial), it may appear a bit surprising thatintracameral cefuroxime is still far from being consis-tently adopted by European ophthalmologists eithersystematically or in targeted cases (ie, high-riskpatients). However, it should be noticed that thecomparative evidence base is incomplete; for instance,the ESCRS trial did not answer many relevant ques-tions such as the relative efficacy of intracameral cefur-oxime compared with a full course of preoperative,perioperative, and postoperative topical antibiotics;subconjunctival injections; or antibiotics in irrigationfluid. Although a systematic comparison of allpossible options in large randomized trials is not

feasible, it may explain why these ophthalmologistsremain unconvinced that they should have changedtheir practices.

It has been suggested that topical fourth-generationfluoroquinolones such as moxifloxacin and gatifloxa-cin would be preferable to intracameral cefuroxime,among other things because of their broader spectrumof activity.61,6567 Fourth-generation fluoroquinoloneswere the most frequent topical antibiotic prophylaxisused by the American Society of Cataract and Refrac-tive Surgery survey respondents in 2007,64 and theirefficacy and safety are further supported by a retro-

spective study involving 29 276 cataract surgeries.68

Other studies have also reported that intracameralmoxifloxacin is safe for IPOE prophylaxis.69,70 TheESCRS guidelines, on the other hand, state that theuse of topical fourth-generation fluoroquinolones,similar to that of intracameral vancomycin, raisesethical questions about the use of reserve antibioticsfor prophylaxis, as opposed to treatment of estab-lished IPOE,10 and the French guidelines state thattopical fluoroquinolones are reserved for curativetreatment of severe eye infections.18

Managing patients with contraindications for cefur-

oxime is a rare issue. Anaphylactic hypersensitivity re-actions, occurring a few minutes after intracameralcefuroxime injection, have been reported27,7173 butare extremely rare, the risk being estimated at0.0001% to 0.1%.19,74,75 In patients with a known al-lergy tocephalosporins, cefuroxime is not recommen-ded.10,18 Suggested alternatives are intracameralinjection of vancomycin with intensive topical quino-lones (eg, levofloxacin, which may be auseful adjunctfor coverage of gram-negative bacteria)10 or preopera-tive oral levofloxacin.18

Antibiotic prophylaxis should be regarded as one

component of a global effective strategy for the control

of healthcare-associated infections.48 The first line ofprevention must always be general hygiene and asep-sis measures, which encompass patient selection, hy-giene rules in the operating room, and surgical siteantisepsis. As stated by the Scottish IntercollegiateGuidelines Network, antibiotics may then be used ina manner that is supported by evidence of effective-ness, minimizing the effects on the patient's normalbacterial flora and causing minimal change to thepatient's host defenses.48 To prevent resistance devel-opment, guidelines have recommended limiting theprescription of oral fluoroquinolones tohigh-risk pa-tients (eg, severe atopic dermatitis).10,76

Pathogens found in proven IPOE cases mostly orig-inate from the eye-surrounding flora,56 and the micro-bial spectrum is dominated by gram-positivestaphylococci and streptococci. Intraocular contami-nation by the facultative pathogenic surrounding flora

has been shown to occur in a high proportion of theprocedures.10,7784 Still, the development of a trueIPOE is rare. In the ESCRS study, 5 significant riskfactors for IPOE development were identified: clearcorneal incisions versus scleral tunnel, surgical com-plications, silicone versus acrylic intraocular lenses(IOLs), less experienced surgeon versus more experi-enced surgeon, and no use of intracameral cefurox-ime.4 Notably, factors such as the use of an IOLinjector, immunosuppression, diabetes mellitus, andthe use of perioperative topical levofloxacin did notaffect the IPOE rate significantly in the ESCRS study.4

It should be emphasized, however, that the literatureregarding many of these IPOE risk factors is contradic-tory. Although some risk factors (such as capsulerupture and vitreous loss) are undisputable, the occur-rence of an IPOE is very difficult to predict, which em-phasizes the importance of an effective prophylacticstrategy in routine practice.

In conclusion, intracameral cefuroxime reduces therisk for IPOE after cataract surgery, as shown by theESCRS study and multiple retrospective Europeanstudies, and is recommended by the ESCRS and thenational guidelines in France.

Five years have passed since the publication of theESCRS study, but the IPOE prophylaxis routines,including the use of intracameral cefuroxime, stillvary widely between European countries. There is aconvergence in antisepsis routines with povidoneiodine and in the use of postoperative topical antibi-otics (despite the findings of the ESCRS study), withfew exceptions. On the contrary, the use of preopera-tive and intraoperative topical antibiotics and the useof intracameral or subconjunctival antibiotics differsignificantly between, and also within, countries.

Controversies about the scientific rationale for intra-

cameral cefuroxime use in some countries, legal




9/11

barriers, and the lack of a commercially available prep-aration appeared to be the major obstacles to system-atic application of this routine.

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