Cystoid Macular Edema Following Cataract Surgery, Bilateral Clinical Trial
Official title:
A Randomized, Masked Comparison of Topical Ketorolac 0,4% Versus Placebo in Cataract Surgery.
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.
| Status | Completed |
| Enrollment | 80 |
| Est. completion date | August 2013 |
| Est. primary completion date | December 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 50 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Unicamp | Campinas | Sao Paulo |
| Brazil | Unicamp | Campinas | Sao Paulo |
| Lead Sponsor | Collaborator |
|---|---|
| University of Campinas, Brazil |
Brazil,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | cystoid macular edema | Angiography (Miyake's criteria) | 1 month | No |
| Secondary | Best corrected visual acuity | ETDRS. | 1 month | No |