A Phase 3 interventional study of Brimonidine Tartrate 0.2% and Timolol maleate 0.5% in Corneal Edema and Visual Acuity, sponsored by Rabin Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-12-02.
Sponsored by Rabin Medical Center · Phase 3, Interventional, and Treatment
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.
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.
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's planned enrollment of 150 is above the median of 80 across 1,155 interventional studies indexed under Cataract.
Browse Cataract studies →Rabin Medical Center is the lead sponsor of 385 studies on the registry; 30 are open to participants now.
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Exclusion Criteria:
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)
Drug: Brimonidine Tartrate 0.2%
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)
Drug: Timolol maleate 0.5%
50 patients will not receive any additional drug to the usual medications after cataract surgery (corticosteroids and antibiotics drops)
Brimonidine Tartrate 0.2% drops 1 drop twice a day for 1 month in the operated eye
Also known as: ALPHAGAN P
timolol maleate 0.5% drops 1 drop twice a day for 1 month in the operated eye
Also known as: TILOPTIC, V-OPTIC
central corneal thickness in micrometer
Time frame: day 0 (day of enrollment ), day 7, day 30
grading of corneal edema (1-3)
Time frame: day 0 (day of enrollment), day 7, day 30
This study is status unknown, as verified in Nov 2008. You cannot join it, but the record below documents what was studied.
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Rabin Medical Center