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

Study Overview
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Brief Summary
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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.

Detailed Description
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Purpose: To compare effects of preoperative and postoperative use of topical ketorolac tromethamine 0.4% versus placebo in uncomplicated cataract surgery. Methods: This will be a masked single-center, randomized clinical study comprising 80 patients undergoing phacoemulsification cataract surgery. Patients scheduled to undergo phacoemulsification and with no recognized cystoid macular edema (CME) risks (diabetic retinopathy, retinal vascular disease or macular abnormality) will be randomized to receive either topical prednisolone acetate 1% 4 times daily (QID) plus dextran 70/hypromellose QID (placebo group;n=40) or topical prednisolone 1% QID plus ketorolac tromethamine 0.4% QID (ketorolac group;n=40) for three days preoperatively and four weeks postoperatively. In both groups topical gatifloxacin will be administered to the treated eye QID, starting three days before surgery and continuing for seven days. The primary outcome 5 weeks after surgery will be angiographic cystoid macular edema. Other included outcomes will be best corrected visual acuity (BCVA), intraocular pressure (IOP), CME incidence, retinal thickness as measured by spectral-domain optical coherence tomography (OCT).

Official Title
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A Randomized, Masked Comparison of Topical Ketorolac 0,4% Versus Placebo in Cataract Surgery.

Conditions
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Cystoid Macular Edema Following Cataract Surgery, Bilateral

Intervention / Treatment
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* Drug: Ketorolac Tromethamine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ketorolac tromethamine<br> | Drug: Ketorolac Tromethamine<br>* ketorolac tromethamine 0.4%<br>* Other names: Lacribell (Latinofarma);|
| Placebo Comparator: Dextrano 70 / Hypromellose<br> | Drug: Ketorolac Tromethamine<br>* ketorolac tromethamine 0.4%<br>* Other names: Lacribell (Latinofarma);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cystoid macular edema | Angiography (Miyake's criteria) | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected visual acuity | ETDRS. | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cataract surgery, cystoid macular edema, angiography