Clinical Trial: Effect of Topical Brimonidine on Post Cataract Surgery Corneal Edema
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Phase 3 Study of Brimonidine Tartrate Drops Efficacy in Reducing Post Operative Corneal Edema After Cataract Surgery
Brief Summary:
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 Summary:
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.
Sponsor: Rabin Medical Center
Current Primary Outcome: central corneal thickness in micrometer [ Time Frame: day 0 (day of enrollment ), day 7, day 30 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: grading of corneal edema (1-3) [ Time Frame: day 0 (day of enrollment), day 7, day 30 ]
Original Secondary Outcome: Same as current
Information By: Rabin Medical Center
Dates:
Date Received: November 30, 2008
Date Started: January 2009
Date Completion: January 2010
Last Updated: December 1, 2008
Last Verified: November 2008
