Randomized Clinical Trial Comparing Prophylactic Nepafenac 0.1% and Ketorolac 0.5% Versus Placebo in Preventing Postoperative Macular Edema After Uncomplicated Phacoemulsification Cataract Extraction (PNK)

Queen's University1 site in 1 country162 target enrollmentFebruary 2010

ConditionsMacular Edema

InterventionsNepafenac 0.1%Ketorolac 0.5%Placebo (sterile saline drops)

DrugsNepafenac 0.1%Ketorolac 0.5%

Overview

Phase: Phase 4
Intervention: Nepafenac 0.1%
Conditions: Macular Edema
Sponsor: Queen's University
Enrollment: 162
Locations: 1
Primary Endpoint: Change in macular volume (as quantified by OCT) at one month (compared to baseline)
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Assess prophylactic efficacy of topical non-steroidal anti-inflammatory drops in preventing macular edema. Patient undergoing uncomplicated cataract surgery will be enrolled and randomized to nepafenac, ketorolac, or placebo. Follow-up will occur at 1 month with ocular coherence tomography (OCT).

Registry

clinicaltrials.gov

Start Date

February 2010

End Date

May 2011

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Queen's University

Responsible Party

Principal Investigator

Dr. Sherif R El-Defrawy

Principal Investigator

Queen's University

Eligibility Criteria

Inclusion Criteria

•Ability to give informed consent
•Age 18 years and older

Exclusion Criteria

•Any pre-existing retinal disease (e.g., diabetic retinopathy, vein occlusion, exudative macular degeneration, etc.)
•Previous uveitis
•Previous intraocular surgery
•Allergy or hypersensitivity to NSAIDs
•Complicated cataract surgery