Effect of Topical Brimonidine on Post Cataract Surgery Corneal Edema

Study Overview
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Brief Summary
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Most patients undergoing cataract surgery suffer from corneal edema after the surgery. Brimonidine drops are a well known and safe Anti-glaucoma medication. the investigators have made several clinical observations that patients receiving Brimonidine drops had a faster resolution of their corneal edema even if they had normal intra-ocular pressure. The investigators believe that administering topical Brimonidine to patients with significant post operative corneal edema will hasten the resolution of their corneal edema.

Detailed Description
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Most patients undergoing cataract surgery suffer from corneal edema after the surgery which temporarily reduces their visual acuity until corneal edema resolves over several weeks Brimonidine drops are a well known and safe Anti-glaucoma medication, used to lower intra ocular pressure. there have been several clinical observations that patients receiving Brimonidine drops had a faster resolution of their corneal edema even in the presence of normal intra-ocular pressure. The investigators postulated that administering topical Brimonidine to patients with significant post operative corneal edema will hasten their recovery and visual improvement. In order to prove that Brimonidine drops contribute to faster resolution of cornel edema and visual improvement, the study will randomly compare 50 post cataract surgery patients (group A)who will be administered Brimonidine to 2 control groups (50 people in each group): group B will be given topical timolol drops 0.5% (another well recognized anti glaucoma medication which reduces intra-ocular pressure by different mechanism than Brimonidine. Group C will not be given any test drug. All 3 groups will receive the regular post operative medications which include corticosteroids and antibiotics.

Official Title
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Phase 3 Study of Brimonidine Tartrate Drops Efficacy in Reducing Post Operative Corneal Edema After Cataract Surgery

Conditions
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Corneal Edema, Visual Acuity

Intervention / Treatment
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* Drug: Brimonidine Tartrate 0.2%
* Drug: Timolol maleate 0.5%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1 day after uneventful cataract surgery corneal edema (grade 2 to 3) Exclusion Criteria: glaucoma higher than normal intraocular pressure (>23 mm Hg) known sensitivity or contra indication to brimonidine known sensitivity or contra indication to timolol pre operative corneal or anterior segment disease intraoperative complications major ocular pathology other than corneal that reduced vision (retinal degeneration, optic neuropathy etc.) pregnant women children

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: brimonidine<br>50 patients receiving Brimonidine Tartrate drops in the operated eye: 1 drop X2 a day for 1 month. they will also be administered the usual medications after cataract surgery (corticosteroids and antibiotics drops) | Drug: Brimonidine Tartrate 0.2%<br>* Brimonidine Tartrate 0.2% drops 1 drop twice a day for 1 month in the operated eye<br>* Other names: ALPHAGAN P;|
| Active Comparator: 2 tmolol<br>50 patients receiving timolol maleate 0.5% drops in the operated eye 1 drop X2 a day for 1 month. they will also be administered the usual medications after cataract surgery (corticosteroids and antibiotics drops) | Drug: Timolol maleate 0.5%<br>* timolol maleate 0.5% drops 1 drop twice a day for 1 month in the operated eye<br>* Other names: V-OPTIC;|
| No Intervention: 3<br>50 patients will not receive any additional drug to the usual medications after cataract surgery (corticosteroids and antibiotics drops) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| central corneal thickness in micrometer |  | day 0 (day of enrollment ), day 7, day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| grading of corneal edema (1-3) |  | day 0 (day of enrollment), day 7, day 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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corneal edema, postoperative corneal edema, central corneal thickness, visual acuity, postoperative, brimonidine, timolol, cataract surgery