Effect of Topical Brimonidine on Post Cataract Surgery Corneal Edema
Information source: Rabin Medical Center
ClinicalTrials.gov processed this data on August 20, 2015 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
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