CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 80 target
Drug / intervention
Ketorolac Tromethaminedrug
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/NCT01542190
NCT01542190Phase 4Completed
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A Randomized, Masked Comparison of Topical Ketorolac 0,4% Versus Placebo in Cataract Surgery.

University of Campinas, Brazil·interventional·Posted Mar 2, 2012·Updated Dec 4, 2014

In Brief

A Phase 4 clinical trial evaluating Ketorolac Tromethamine for Cystoid Macular Edema Following Cataract Surgery, Bilateral. Completed, enrolled 80 participants across 2 sites.

Detailed Summary

The purpose of this study is to compare effects of preoperative and postoperative use of topical ketorolac tromethamine 0.4% versus placebo in uncomplicated cataract surgery. Patients scheduled to undergo phacoemulsification will be randomized to receive either topical prednisolone acetate 1% 4 times daily (QID) plus dextran 70/hypromellose QID (placebo group) or topical prednisolone 1% QID plus ketorolac tromethamine 0.4% QID (ketorolac group) for three days preoperatively and four weeks postoperatively. The primary outcome 5 weeks after surgery will be angiographic cystoid macular edema.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystoid Macular Edema Following Cataract Surgery, Bilateral
CountriesBrazil
Collaborators--

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2, 2012
Enrollment StartFeb 1, 2011
Primary CompletionDec 1, 2012
Study CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 14.3 years ago

Interventions

Ketorolac Tromethaminedrug

ketorolac tromethamine 0.4%