Effect of Topical Brimonidine on Post Cataract Surgery Corneal Edema

Phase 3

• Conditions: Corneal Edema; Visual Acuity
• Interventions: Drug: Timolol maleate 0.5%; Drug: Brimonidine Tartrate 0.2%

• Registration Number: NCT00800423
• Lead Sponsor: Rabin Medical Center

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 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.

Study Timeline

• Status Verified: 2008-11
• Study First Submitted: 2008-11-30
• Study First Submitted QC: 2008-12-01
• Last Update Submitted: 2008-12-01
• Study First Posted: 2008-12-02
• Last Update Posted: 2008-12-02
• Study Start: 2009-01
• Primary Completion: 2010-01
• Study Completion: 2010-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2 tmolol	Timolol maleate 0.5%	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)
brimonidine	Brimonidine Tartrate 0.2%	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)

Primary Outcome Measures

Name	Time	Method
central corneal thickness in micrometer	day 0 (day of enrollment ), day 7, day 30

Secondary Outcome Measures

Name	Time	Method
grading of corneal edema (1-3)	day 0 (day of enrollment), day 7, day 30

Trial Locations

Locations (1)

Rabin medical center ophthalmology deparment; 🇮🇱 Petah-Tikva, Israel