CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 82 enrolled
Drug / intervention
Standard Care +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00494494
NCT00494494Phase 4Completed

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

University of North Carolina, Chapel Hill·interventional·Posted Jun 29, 2007·Updated Jul 12, 2011

In Brief

A Phase 4 clinical trial evaluating Standard Care and nepafenac for Cystoid Macular Edema. Completed, enrolled 82 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 29, 2007
Enrollment StartJun 1, 2007
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 19.0 years ago

Interventions

Standard Caredrug

topical antibiotic for 10 days plus topical corticosteroids for 1 month

nepafenacdrug

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