Effect of Topical Brimonidine on Post Cataract Surgery Corneal Edema

Visual Acuity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00800423
• Other study ID #: 5189
• Status: Not yet recruiting
• Phase: Phase 3
• First received: November 30, 2008
• Last updated: December 1, 2008
• Start date: January 2009
• Est. completion date: January 2010

Study information

• Verified date: November 2008
• Source: Rabin Medical Center
• Contact: Anat Robinson, MD
• Phone: 9729377176
• Email: robina[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Corneal Edema
• Edema
• Visual Acuity

Intervention

Drug:
• Brimonidine Tartrate 0.2%
Brimonidine Tartrate 0.2% drops 1 drop twice a day for 1 month in the operated eye
• Timolol maleate 0.5%
timolol maleate 0.5% drops 1 drop twice a day for 1 month in the operated eye

Locations

Country	Name	City	State
Israel	Rabin medical center ophthalmology deparment	Petah-Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	central corneal thickness in micrometer		day 0 (day of enrollment ), day 7, day 30	No
Secondary	grading of corneal edema (1-3)		day 0 (day of enrollment), day 7, day 30	No