Clinical trial NCT00800423: Effect of Topical Brimonidine on Post Cataract Surgery Corneal Edema
Official title: Phase 3 Study of Brimonidine Tartrate Drops Efficacy in Reducing Post Operative Corneal Edema After Cataract Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Corneal Edema
Visual Acuity
Keywords: corneal edema
postoperative corneal edema
central corneal thickness
visual acuity
postoperative
brimonidine
timolol
cataract surgery
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2008-12-02
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: central corneal thickness in micrometer
timeFrame: day 0 (day of enrollment ), day 7, day 30
Secondary outcomes:
measure: grading of corneal edema (1-3)
timeFrame: day 0 (day of enrollment), day 7, day 30
Other outcomes:
Locations:
city: Petah-Tikva
country: Israel
facility: Rabin medical center ophthalmology deparment
Study officials:
affiliation: Rabin medical center, Clalit health services , Israel
name: Anat Robinson, MD
role: PRINCIPAL_INVESTIGATOR
References: