Current Strategies

IN ROUTINE AND HIGH-RISKCATARACT SURGERY PATIENTS

CME/CE Syllabus

for Inflammation Prevention

Thursday, September 12, 2013Monday, September 16, 2013Wednesday, September 18, 2013Monday, September 23, 2013Tuesday, September 24, 2013

This continuing medical education activity was jointly sponsoredby The New York Eye and Ear Infirmary and MedEdicus LLC

In cooperation with

Administrator:

This CME/CE activity was supported through an unrestrictededucational grant from Alcon, Inc, a Novartis company.

Faculty

Stephen S. Lane, MDMedical Director Associated Eye C are Adjunct Clinical Professor of Ophthalmology University of Minnesota Minneapolis, Minnesota

Rishi P. Singh, MDStaff Physician Department of Ophthalmology – Retina Service Cole Eye Institute Cleveland Clinic Foundation Cleveland, Ohio

Paul M. Karpecki, OD, FAAOClinical Director Corneal Services and Ocular Disease Research Koffler Vision Group Lexington, Kentucky

Prevention of inflammation and macular edema remain important goals in achieving good outcomes for today’s cataract surgerypatients. New research in high-risk patients and new treatments are available with which ophthalmologists and optometrists needto be familiar. The goal of the webinar program was to provide ophthalmologists and optometrists with new information andexpert insights on the management of these patients. Thank you for participating in the webinar. This syllabus is a summary ofthe program for your information and does not offer CME or CE credit. We hope you found this activity valuable and that it willenhance your treatment of patients undergoing cataract surgery.

TARGET AUDIENCE This program intended to educate ophthalmologists and optometrists.

PROGRAM LEARNING OBJECTIVES Upon completion of this activity, the learner should have been better able to:• Identify the signs and symptoms of cataract early to result in timely optometrist-to-cataract surgeon referrals• Assess cataract surgery patients’ risk for postoperative inflammation and macular edema• Evaluate the anti-inflammatory agents used in cataract surgery on efficacy, safety, patient comfort• Apply appropriate perioperative therapies for postoperative inflammation and macular edema prevention• Describe effective co-management practices to manage or prevent inflammation in postcataract surgery populations• Report on PQRS (Performance Quality Rating Scale) outcomes, complications, and satisfaction for appropriate patientsundergoing cataract surgery

ACCREDITATION STATEMENT This activity was planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council forContinuing Medical Education through the joint sponsorship of The New York Eye and Ear Infirmary and MedEdicus LLC. The New York Eye and Ear Infirmary is accredited by the ACCME to provide continuing medical education for physicians.

In July 2013, the Accreditation Council for Continuing Medical Education (ACCME) awarded The New York Eye and EarInfirmary Institute for Continuing Medical Education “Accreditation with Commendation,” for six years as a provider ofcontinuing medical education for physicians, the highest accreditation status awarded by the ACCME.

GRANTOR STATEMENT This CME/CE activity was supported through an unrestricted educational grant from Alcon, Inc, a Novartis company.

DISCLOSURE POLICY STATEMENT It is the policy of The New York Eye and Ear Infirmary that the faculty and planners disclose any real or apparent conflicts ofinterest relating to the topics of this educational activity, and also disclose discussions of unlabeled/unapproved uses of drugs ordevices during their presentation(s). The New York Eye and Ear Infirmary has established polices in place that will identify andresolve all conflicts of interest prior to this educational activity.

FACULTY DISCLOSURESPaul M. Karpecki, OD, had a financial agreement or affiliation during the past year with the following commercial interests in theform of Consultant/Advisory Board: Abbott Medical Optics; Akorn Incorporated; Alcon Inc; Allergan Inc; Arctic Dx, Inc; Bausch +Lomb Incorporated; BioTissue, Inc; Bruder Healthcare Company; Focus Laboratories, Inc; iCare USA; Johnson & Johnson; MarcoOphthalmic; OCuSOFT, Inc; Odyssey Medical, Inc; SARcode BioScience, Inc; ScienceBased Health; Shire Pharmaceuticals;TearLab Corporation; Topcon Medical Systems, Inc; and Vmax Vision, Inc; Contracted Research: Bausch + Lomb Incorporated;Rigel Pharmaceuticals, Inc; and Shire Pharmaceuticals; Fees from promotional, advertising or non-CME services received directlyfrom commercial interests or their Agents (eg, Speakers Bureaus): Essilor Laboratories of America; Merck & Co, Inc; andOCULUS, Inc; Board of Directors: TearLab Corporation.

Stephen S. Lane, MD, had a financial agreement or affiliation during the past year with the following commercial interests in theform of Consultant/Advisory Board: Abbott Medical Optics; Alcon, Inc; Bausch + Lomb Incorporated; Kala Pharmaceuticals Inc;Omeros Corporation; VisionCare Ophthalmic Technologies, Inc; and WaveTec Vision.

Rishi P. Singh, MD, had a financial agreement or affiliation during the past year with the following commercial interests in theform of Honoraria: Alcon, Inc; Bausch + Lomb Incorporated; Genentech, Inc; and Regeneron Pharmaceuticals, Inc; ContractedResearch: Alcon, Inc; Bausch + Lomb Incorporated; and Regeneron Pharmaceuticals, Inc.

EDITORIAL SUPPORT DISCLOSURESMichelle Dalton, ESL, had a financial agreement or affiliation during the past year with the following commercial interests in theform of Editorial Services: Bausch + Lomb/ISTA Pharmaceuticals, Inc; Bayer HealthCare; EyeWorld; Informa Healthcare; InSiteVision Incorporated; PentaVision; ReVision Optics, Inc; SM2 Consulting; and Sonomed Escalon. Cynthia Tornallyay, RD, MBA,CCMEP; Kimberly Corbin, CCMEP; Barbara Aubel; and Barbara Lyon have no relevant commercial relationships to disclose.

PEER REVIEW DISCLOSUREAlice Epitropoulos, MD, had a financial agreement or affiliation during the past year with the following commercial interests inthe form of Receipt of Intellectual Rights/Patent Holder (and spouse): Epico, Inc; Honoraria from promotional, advertising or non-CME services received directly from commercial interests or their Agents (eg, Speakers Bureaus): Allergan, Inc; and Bausch +Lomb Incorporated; Ownership Interest (and spouse): Epico, Inc.

DISCLOSURE ATTESTATION The contributing physicians listed above have attested to the following:1. that the relationships/affiliations noted will not bias or otherwise influence their involvement in this activity;2. that practice recommendations given relevant to the companies with whom they have relationships/affiliations will be

supported by the best available evidence or, absent evidence, will be consistent with generally accepted medical practice; and3. that all reasonable clinical alternatives will be discussed when making practice recommendations.

OFF-LABEL DISCUSSIONThis activity included off-label discussion of NSAIDs for CME.

SYSTEM REQUIREMENTSWhen viewing this syllabus online, please ensure the computer you are using meets the following requirements:• Operating System: Windows or Macintosh• Media Viewing Requirements: Flash Player or Adobe Reader• Supported Browsers: Microsoft Internet Explorer, Firefox, Google Chrome, Safari, and Opera• A good Internet connection

THE NEW YORK EYE AND EAR INFIRMARY PRIVACY & CONFIDENTIALITY POLICIESCME policies: http://www.nyee.edu/cme-enduring.htmlHospital policies: http://www.nyee.edu/website-privacy.html

CME/CE PROVIDER CONTACT INFORMATIONFor CME questions about this activity, call The New York Eye and Ear Infirmary 212-979-4383.For CE questions about this activity, call MedEdicus 203-493-8077.

DISCLAIMER The views and opinions expressed in this educational activity were those of the faculty and do not necessarily represent the views of The New York Eye and Ear Infirmary; NOVA Southeastern College of Optometry; MedEdicus LLC; or Alcon, Inc, a Novartis company.

Cataract Surgery: Increasing Demands

• By 2020, nearly 10% of US population (more than 30 

million people) will have cataracts1

• 20/40 VA is no longer an acceptable postsurgical goal

• Patients do not want their lifestyles altered by 

decreased vision

• Prompt diagnosis/Referral to cataract surgeon will 

continue to be imperative

1. Congdon N et al; Eye Diseases Prevalence Research Group. Arch Ophthalmol. 2004;122(4):487‐494.

Primary Causes of Postoperative Complaints

•Deteriorating vision in early postoperative period 

• May be indicative of cystoid macular edema (CME)

•Pain 

Importance of Controlling Postoperative Ocular Inflammation

•Reduce pain1‐3

• Increase patient comfort

•Decrease risk of CME1,4,5

• Improve patient outcomes

•Meet quality measures

1. European Medicines Agency. Nevanac. 2012.  2. Bausch + Lomb. 2013.  3. Ilevro [package insert]. Fort Worth, TX: Alcon Laboratories, Inc;  2013.  4. Donnenfeld ED et al. J Cataract Refract Surg. 2006;32(9):1474‐1482.  5. AAO Preferred Practice Pattern® Guidelines: Cataract in the Adult Eye. 2011.  

PQRS* Registry Group –Measures for Cataract Surgery

• Needs to be reported for 20 unique Medicare Part B FFS patients within the reporting period

• MEASURE 191 – Cataracts: 20/40 or Better Visual Acuity Within 90 Days Following Cataract Surgery

• MEASURE 192 – Cataracts: Complications Within 30 Days Following Cataract Surgery Requiring Additional Surgical Procedures

• MEASURE 303 – Cataracts: Improvement in Patient's Visual Function Within 90 Days Following Cataract Surgery

• MEASURE 304 – Patient Satisfaction Within 90 Days Following Cataract Surgery

* Performance Quality Rating Scale

Current Issues….

•Meaningful use

• NOT concurrent with PQRS

• Only after maxed out in meaningful use can practices collect any PQRS incentives

•Delivery of eye care services 

• Will be more scrutinized in the future

Optimal Patient Care

PatientPatient

OptometristOptometrist

Cataract surgeonCataract surgeon

Retina (or other) specialist

Retina (or other) specialist

Factors Influencing Postoperative Inflammation

• Cataract density

• Associated with errors in axial length measurement1

• Increases potential complications2

• Poorer refractive outcomes1 

• Earlier detection reduces risk of complications/“high risk” surgery

• History of disease

• Iris pigmentation

• Darker irides are more prone to inflammation

1. Ueda T et al. J Cataract Refract Surg. 2010;36(5):806‐809.  2. Martin KR, Burton RL. Eye (Lond). 2000;14(Pt 2):190‐195.

Patients at High Risk for Inflammation

•Glaucoma

•Retinitis pigmentosa

•Rheumatoid arthritis

•History of iritis

•Diabetes 

•Denser cataracts Image Courtesy of Paul M. Karpecki, OD

Cystoid Macular Edema• Most common cause of postoperative decreased vision in uneventful cataract surgery1

• incidence w/ intraoperative complications2

• Substantially  in DR/uveitis3,4

• Subclinical CME may be detected with FA or OCT4,5

• Angiographic CME approximately 10%‐20%4

• Clinical CME occurs in ~1%‐2% of patients6

1. Flach AJ. Trans Am Ophthalmol Soc. 1998;96:557‐634.  2. Cho H, Madu A. J Inflamm Res. 2009;2:37‐43.  3. Johnson MW. Am J Ophthalmol. 2009;147(1):11‐21.  4. Sahin M et al. J Ophthalmol. 2013;2013:376013.  5. Ouyang Y et al. Invest Ophthalmol Vis Sci. 2010;51(10):5213‐5218.  6. Ray S, D’Amico DJ. Semin Ophthalmol. 2002;17(3‐4):167‐180.

Trends in Preoperative Inflammation Prophylaxis• Preoperative use of NSAIDs is increasing1‐6

• Interruption of the inflammatory cascade

• Commencement of therapy 1 to 2 days prior to procedure

1. Donnenfeld ED et al. J Cataract Refract Surg. 2006;32(9):1474‐1482.  2. Miyake K et al. J Cataract Refract Surg. 2011; 37(9):1581‐1588.  3. Burling‐Phillips L. Clinical Update: Retina. EyeNet Magazine. http://www.aao.org/publications/eyenet/200701/retina.cfm.  4. Wittpenn et al. AAO. 2006.  5. Jampol LM. Ophthalmology. 1982;89(8):891‐897.  6. Jampol LM. Ophthalmology. 1985;92(6):807‐810. 

Trends in Postoperative Inflammation Prophylaxis • Longer regimens used postoperatively1,2

• Up to 90 days in high‐risk patients1

• Up to 5 weeks for CME prevention3

• Once‐daily dosing to better aid in patient adherence during long‐term therapy

1. Singh R et al. Clin Ophthalmol. 2012;6:1259‐1269.  2. Wang QW et al. Ophthalmologica. 2013;229(4):187‐94. 3. Miyake K et al. J Cataract Refract Surg. 2011;37(9):1581‐1588.

NSAIDs – Efficacy • Approved in the United States for the treatment of postoperative pain and inflammation associated with cataract surgery1,2 

Medication Strength/Trade Name

Dosing

Bromfenac 0.07% (Prolensa)0.09% (Bromday)0.09% generic

Once dailyOnce dailyTwice daily

Diclofenac 0.1% (Voltaren)0.1% generic

Four times dailyFour times daily

Flurbiprofen* 0.03% (Ocufen)0.03% generic

One drop every 30 minutes X4

Ketorolac 0.4% (Acular LS)0.45% (Acuvail)0.5% (Acular)

Four times dailyTwice dailyFour times daily

Nepafenac 0.1% (Nevanac)0.3% (Ilevro)

Three times dailyOnce daily

1. Flach AJ. Int Ophthalmol Clin. 2002;42(1):1‐11.  2. O’Brien TP. Curr Med Res Opin. 2005;21(7):1131‐1137. 

*For inhibition of intraoperative miosis

NSAIDs and CME Prevention

•Off‐label in the United States, but studies show effectiveness in CME prevention• Bromfenac

• Greater efficacy vs dexamethasone or fluorometholone1

• Ketorolac2

• Meta‐analysis: ketorolac reduced risk of CME development vs controls at the end of treatment

• Nepafenac• Prevented macular edema and maintained visual acuity after 90 days of therapy in patients with diabetes3

• Labeled in Europe for CME prevention4

1. Wang QW et al. Ophthlamologica. 2013;229(4):187‐194.  2. Yilmaz T et al. Eye (Lond). 2012;26(2):252‐258.  3. Singh R et al. Clin Ophthalmol. 2012;6:1259‐1269.  4. Nevanac. European Medicines Agency. 2012.

NSAID Safety

•Corneal complications rare1‐4

• Singh et al. reported no corneal erosions with nepafenac after 90 days of dosing  (n=133)2

• Bromfenac’s serious adverse events over 6 years = 0.0002%3

• Rare reports of corneal infiltrates and ulcerative keratolysis

• Generic diclofenac (61% of 117 cases)4

• Branded ketorolac (12% of 117 cases)4

• Branded diclofenac (27% of 117 cases)4

1. Flach AJ. Int Ophthalmol Clin. 2002;42(1):1‐11.  2. Singh R et al. Clin Ophthalmol. 2012;6:1259‐1269.  3. Carreño E et al. Clin Ophthalmol. 2012;6:637‐644.  4. O’Brien TP. Curr Med Res Opin. 2005;21(7):1131‐1137.

Steroids – Efficacy and Safety

• Ketone steroids

• Dexamethasone – potent, high IOP potential• Difluprednate – highly potent1

Emulsion – no need to shake, dose  uniformity

• Fluorometholone• Prednisolone acetate – potent glucocorticoid• Rimexolone – preferable for patients w/high IOP2

• Ester steroids

• Loteprednol etabonateLess likely to induce IOP elevations vs C‐20 ketone steroids3,4

Gel formulation – no shaking

1. Donnenfeld ED. Clin Ophthalmol. 2011;5:811‐816.  2. Tessler HH. Manag Care. 2002;11(1 suppl):12‐15.  3. Comstock TL, Holland EJ. Expert Opin Pharmacother. 2010;11(5):843‐852.  4. Comstock TL, Decory HH. Int J Inflam. 2012;2012:789623.

Combination Steroid/NSAID Postoperative Treatments• Few studies evaluate combination NSAID/steroid

• Henderson (2007) showed cataract patients treated with combination steroid/NSAID recovered from CME more 

quickly than those who had no treatment1

• Wittpenn et al. showed using combination improved contrast sensitivity and prohibited CME development2

• Flach noted potential for synergistic effect3

1. Henderson BA et al. J Cataract Refract Surg. 2007;33(9):1550‐1558.  2. Wittpenn JR et al; Acular LS for Cystoid Macular Edema (ACME) Study Group. Am J Ophthalmol. 2008;146(4):554‐560.  3. Flach AJ. Int Ophthalmol Clin. 2002;41(1):1‐11.

Case 1

•59 y.o. male underwent uneventful cataract surgery

• VA 20/25

• IOP normal

•Anti‐inflammatory regimen postoperatively:

• Prednisolone acetate 4x/day until follow‐up visit

• NSAID 1x/day until follow‐up visit

•Patient instructed to return to optometrist in 1 week

Case 1:  Discussion at Follow‐up Visit

• Early communication between surgeon and optometrist is key

• Follow‐up evaluation points

• Assessment of visual acuity, IOP, and patient expectations

• Ocular surface assessment, anterior chamber evaluation, potential for CME

Case 1

•Patient was examined postoperatively wk 1

• VA 20/40

• IOP normal

• Slit lamp:  

• Moderate diffuse conjunctival injection

• Clear cornea

• 2+ cell and flare

•Patient reveals he stopped taking steroids and NSAIDs 2 days postoperatively

Case 1: Treatment Discussion

•Helpful aids in ensuring patient adherence

• Ask direct questions about medication

• Observe how the patient puts drops in his/her eye

•Consideration of components of anti‐inflammatory therapy

• Steroids 

• NSAIDs

•Arrangement of timely follow‐up

Case 1

•Patient is told to continue steroids and NSAIDs and return to optometrist in 4 days

•Optometrist visit examination• VA 20/60

• 3+ cell and flare

• Inferior corneal edema

• IOP = 28 mm Hg

• Scrutiny of history, signs, and symptoms to establish etiology – eg, endophthalmitis vspostoperative inflammation

Photo Courtesy of Stephen S. Lane, MD

Slit Lamp Examination

Photo Courtesy of Stephen S. Lane, MD

Gonioscopic Examination

Treatment

•Patient sent back to surgeon for nuclear fragment removal

•Postoperative medications:• Difluprednate1,2

• Antibiotic

• NSAID

•Recheck  • 1 week with optometrist

Photo Courtesy of Stephen S. Lane, MD1. Donnenfeld ED et al. Am J Ophthalmol. 2011;152(4):609‐617. 2. Tajika T et al. J Ocul Pharmacol Ther. 2011;27(1):29‐34.

1 Week Later….

•VA 20/20

•Cornea clear

•A/C trace cell and flare

• IOL good position

• IOP normal

•HAPPY PATIENT

Discussion and Take‐Home Points

• Integrated care system – one of the keys to success:

• Meticulous attention to medications with regular patient discussions

•Potential for synergistic benefit with combination of steroids/NSAIDs

Case 2

•84 y.o. female 

•Preoperative history of moderate nonproliferative diabetic retinopathy  

•Had uneventful cataract surgery on 2/4/12

•VA prior to surgery is 20/100 best corrected

•Anti‐inflammatory regimen was:

• Preoperative:  NOTHING

• Postoperative:  Prednisolone acetate 4x/day for 1 week; NSAID 1x/day for 1 week

Case 2: Post‐Cataract Surgery

•Postoperative day #1: VA is 20/40

•Postoperative week #1: VA is 20/30

•Postoperative month #1: VA drops to 20/300

40314.5696ILM - RPE

CubeAverage

Thickness(µm)

CubeVolume(mm³)

CentralSubfield

Thickness(µm)

40314.5696ILM - RPE

CubeAverage

Thickness(µm)

CubeVolume(mm³)

CentralSubfield

Thickness(µm)

Photos Courtesy of Rishi P. Singh, MD

3/29/2012: FA

Photos Courtesy of Rishi P. Singh, MD

Case 2: Discussion

•Retinal assessment to help establish diagnosis

• Examination of hallmarks to pinpoint etiology of inflammation

• Postoperative inflammation?

• Worsening diabetic macular edema?

3/29/2012:  FA

Photos Courtesy of Rishi P. Singh, MD

Case 2: Discussion

•Re‐evaluate patient history

•What discussions should we now have with the patient and anyone involved in her care?

• Timely consideration of specialist involvement

• Importance of inflammation management

Case 2: Discussion

•Consideration of preoperative OCTs 

• Patients who are at higher risk for developing CME

• Patients who will receive advanced technology IOLs

•Consideration of off‐label extended dosing of NSAIDs

Case 2: Treatment

•NSAID and steroid treatment initiated

•Patient followed for several months

4/24/2012: (VA:  20/200) 5/29/2012 :  (VA:  20/100)

7/9/2012:  (VA:  20/50) 8/20/2012 :  (VA:  20/30)

VA and Edema OCT During Treatment

Pho

tos

Cou

rtes

y of

Ris

hi P

. Sin

gh, M

DTake‐Home Points for Best Practice

• Patients with preexisting retinopathies are at higher risk for development of ME

• Preoperative and postoperative treatment can help prevent more severe visual side effects after cataract surgery

• Combination treatment (steroids/NSAIDs) may be superior to monotherapy alone