CompletedPhase 4

Comparison of Topical Ketorolac 0,4% Versus Placebo in Cataract Surgery

Brazil80 participantsStarted 2011-02

Plain-language 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.

Who can participate

Age range50 Years

SexALL

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Inclusion Criteria: * Subjects with nuclear cataract, density 1 and 2 classified by LOCS II, scheduled to undergo phacoemulsification cataract surgery. Exclusion Criteria: * Patients with: * Diabetes, * Hypertension, * uveitis, * macular disease, * congenital ocular abnormalities, * cataract density 0 and 3 by LOCS II, * pseudoexfoliation syndrome. Patients under treatment with nonsteroidal antinflammatory drugs or topical eye drops were excluded.

What they're measuring

cystoid macular edema

Timeframe: 1 month

Trial details

NCT IDNCT01542190

SponsorUniversity of Campinas, Brazil

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-12

View on ClinicalTrials.gov More Cystoid Macular Edema Following Cataract Surgery, Bilateral trials