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Effect of Topical Brimonidine on Post Cataract Surgery Corneal Edema

Information source: Rabin Medical Center
ClinicalTrials.gov processed this data on November 27, 2014
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Corneal Edema; Visual Acuity

Intervention: Brimonidine Tartrate 0.2% (Drug); Timolol maleate 0.5% (Drug)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: Rabin Medical Center

Official(s) and/or principal investigator(s):
Anat Robinson, MD, Principal Investigator, Affiliation: Rabin medical center, Clalit health services , Israel

Overall contact:
Anat Robinson, MD, Phone: 9729377176, Email: robina@clalit.org.il

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.

Clinical Details

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

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

Primary outcome: central corneal thickness in micrometer

Secondary outcome: grading of corneal edema (1-3)

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Anat Robinson, MD, Phone: 9729377176, Email: robina@clalit.org.il

Rabin medical center ophthalmology deparment, Petah-Tikva 49100, Israel; Not yet recruiting
Weinberger Dov, MD, Phone: 9729376101, Email: dwin@clalit.org.il
Omer bialer, MD, Phone: 9729377171, Email: omerb@clalit.org.il
omer y bialer, MD, Sub-Investigator
Anat Robinson, MD, Principal Investigator
Additional Information

Starting date: January 2009
Last updated: December 1, 2008

Page last updated: November 27, 2014

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