Effect of Topical Brimonidine on Post Cataract Surgery Corneal Edema

Clalit Health Services

Status and phase: Unknown; Phase 3

Conditions: Corneal Edema; Visual Acuity

Treatments: Drug: Timolol maleate 0.5%; Drug: Brimonidine Tartrate 0.2%

Study type: Interventional

Funder types: Other

Identifiers

NCT00800423

5189

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

brimonidine

Experimental group

Description:

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)

Treatment:

Drug: Brimonidine Tartrate 0.2%

2 tmolol

Active Comparator group

Description:

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)

Treatment:

Drug: Timolol maleate 0.5%

3

No Intervention group

Description:

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