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

NCT01542190 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2014-12-04

No results posted yet for this study

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.

Conditions

  • Cystoid Macular Edema Following Cataract Surgery, Bilateral

Interventions

DRUG

Ketorolac Tromethamine

ketorolac tromethamine 0.4%

Sponsors & Collaborators

  • University of Campinas, Brazil

    lead OTHER

Principal Investigators

  • Rodrigo PC Lira · University of Campinas, Brazil

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2012-12-31
Completion
2013-08-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01542190 on ClinicalTrials.gov