Effect of Nepafenac on Post-operative Macular Swelling Following Uncomplicated Cataract Surgery

NCT ID: NCT00494494

Last Updated: 2011-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2008-04-30

Brief Summary

Purpose: Study the effect of nepafenac ophthalmic suspension 0.1% to prevent post-operative cystoid macular edema following uncomplicated cataract surgery

Participants: Patients having cataract surgery at UNC who meet eligibility criteria

Procedures (methods): Patients will have pre and post-operative vision measured and optical coherence tomography (OCT) testing, also cataract density and intraoperative phacoemulsification parameters including ultrasound power and ultrasound time will be measured. Patients will be randomized into two groups. Group 1 will be treated with standard post-operative cataract management. Group 2 will be treated with standard post-operative cataract management plus topical nepafenac for one month. Post-operative macular thickness will be studied by analyzing the visual acuity and OCT measurements at two months post surgery.

Detailed Description

We plan to enroll 80 patients in this prospective randomized clinical trial. Eligible patients will be randomized into two groups. All patients will have pre-operative Early Treatment of Diabetic Retinopathy Study (ETDRS) vision measured and pre-operative OCT (Humphrey-Zeiss Medical Systems, San Leandro, CA) in both eyes. OCT measurements will include total macular volume, central foveal thickness, and average macular thickness. Pre-operatively, all cataracts will be graded using the LOCS III classification system.10 Group 1 will receive pre-operative topical nepafenac to maintain intra-operative pupillary dilation which is standard care for cataract surgery. Following surgery Group 1 will be treated with standard post operative cataract treatment, including a topical antibiotic and a topical corticosteroid. Group 2 will also receive pre-operative topical nepafenac to maintain intra-operative pupillary dilation. Following surgery patients in Group 2 will be treated with topical nepafenac, a topical antibiotic, and a topical corticosteroid. Group 2 will be given the 3ml bottle of nepafenac to take home and instructed to use it three times per day for one month. Intra-operative surgical parameters including ultrasound time and average percent phacoemulsification power will be recorded for all surgeries. All patients will be seen on post-operative day one, one week, one month, and two months. At the two month visit, best corrected ETDRS vision and OCT will be repeated in both eyes. The two month visual acuity and post-operative OCT will be analyzed to evaluate the effect of nepafenac on CME following cataract surgery. Wilcoxon signed rank test will be used to compare pre-operative and post-operative differences between visual acuity and OCT measurements. The Spearman correlation will be used to compare the variables in the study including cataract density, ultrasound time, average percent phacoemulsification power, and OCT measurements.

Conditions

Cystoid Macular Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Standard Treatment

topical antibiotic for 10 days and a topical corticosteroid for 1 month

Group Type: ACTIVE_COMPARATOR

Standard Care

Intervention Type: DRUG

topical antibiotic for 10 days plus topical corticosteroids for 1 month

Nepafenac

1 drop per study eye three times per day for 30 days in addition to standard care

Group Type: EXPERIMENTAL

nepafenac

Intervention Type: DRUG

liquid drops, administered three times per day for 1 month in addition to standard care use of topical antibiotic and topical corticosteroid

Interventions

Standard Care

topical antibiotic for 10 days plus topical corticosteroids for 1 month

Intervention Type: DRUG

nepafenac

liquid drops, administered three times per day for 1 month in addition to standard care use of topical antibiotic and topical corticosteroid

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• over age 50
• having cataract surgery at UNC

Exclusion Criteria

• medically controlled diabetes
• history of intraocular surgery
• abnormal pre-op optical coherence tomography scan
• history of ocular inflammation
• have age related macular degeneration

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Research to Prevent Blindness

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

UNC Chapel Hill

Principal Investigators

Kenneth C Cohen, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

05-3115

Identifier Type: -

Identifier Source: org_study_id