Effect of Topical Brimonidine on Post Cataract Surgery Corneal Edema

Sponsor

Rabin Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT00800423

Collaborator

(none)

150

Enrollment

Location

Arms

Duration (Months)

12.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Corneal Edema Visual Acuity	Drug: Brimonidine Tartrate 0.2% Drug: Timolol maleate 0.5%	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2009

Anticipated Primary Completion Date :

Jan 1, 2010

Anticipated Study Completion Date :

Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: brimonidine 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% Brimonidine Tartrate 0.2% drops 1 drop twice a day for 1 month in the operated eye Other Names: ALPHAGAN P
Active Comparator: 2 tmolol 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% timolol maleate 0.5% drops 1 drop twice a day for 1 month in the operated eye Other Names: TILOPTIC V-OPTIC
No Intervention: 3 50 patients will not receive any additional drug to the usual medications after cataract surgery (corticosteroids and antibiotics drops)

Arm

Intervention/Treatment

Experimental: brimonidine

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%

Brimonidine Tartrate 0.2% drops 1 drop twice a day for 1 month in the operated eye

Other Names:

ALPHAGAN P

Active Comparator: 2 tmolol

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%

timolol maleate 0.5% drops 1 drop twice a day for 1 month in the operated eye

Other Names:

TILOPTIC

V-OPTIC

No Intervention: 3

50 patients will not receive any additional drug to the usual medications after cataract surgery (corticosteroids and antibiotics drops)

Outcome Measures

Primary Outcome Measures

central corneal thickness in micrometer [day 0 (day of enrollment ), day 7, day 30]

Secondary Outcome Measures

grading of corneal edema (1-3) [day 0 (day of enrollment), day 7, day 30]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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