NCT00800423

Effect of Topical Brimonidine on Post Cataract Surgery Corneal Edema

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Corneal Edema
• Visual Acuity

Interventions

Type	Name	Description
DRUG	Brimonidine Tartrate 0.2%	Brimonidine Tartrate 0.2% drops 1 drop twice a day for 1 month in the operated eye
DRUG	Timolol maleate 0.5%	timolol maleate 0.5% drops 1 drop twice a day for 1 month in the operated eye

Timeline

• Start date: 2009-01-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2008-12-02
• Last updated: 2008-12-02

Locations

1 site across 1 country: Israel