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

Phase 4

Completed

• Conditions: Cystoid Macular Edema
• Interventions: Drug: Standard Care; Drug: nepafenac

• Registration Number: NCT00494494
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-06-28
• Study First Submitted QC: 2007-06-28
• Study First Posted: 2007-06-29
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Results First Submitted: 2011-04-11
• Status Verified: 2011-06
• Results First Submitted QC: 2011-06-13
• Last Update Submitted: 2011-06-13
• Results First Posted: 2011-07-12
• Last Update Posted: 2011-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

• over age 50
• having cataract surgery at UNC

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Standard Treatment	Standard Care	topical antibiotic for 10 days and a topical corticosteroid for 1 month
Nepafenac	nepafenac	1 drop per study eye three times per day for 30 days in addition to standard care

Primary Outcome Measures

Name	Time	Method
Central Macular Thickness (Difference in Mean Pre-post Changes by the Two Treatment Groups)	baseline and 8 weeks	The endpoints of the study were change in macular thickness measured by OCT in the central 1mm diameter centred on the fovea (central macular thickness)
Pre-operative Best Corrected Visual Acuity (BCVA)	baseline	Patients were instructed to read letters on the EDTRS visual acuity chart. The mean and standard deviation for each group was measured. Letters range from 0 (20/2000) to 110 (20/12.5), with the higher number signaling better visual acuity.
Foveal Thickness	baseline and 8 weeks	difference in mean pre-post changes by the two treatment groups
Macular Volume (Difference in Mean Pre-post Changes by the Two Treatment Groups)	baseline and 8 weeks
Post-operative Best Corrected Visual Acuity (BCVA)	baseline and 8 weeks	The patients were again instructed to read letters on the ETDRS chart 8 weeks post-surgery. The mean and standard deviation for each group was recorded. Letters range from 0 (20/2000) to 110 (20/12.5), with the higher number signaling better visual acuity.

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States