Effect of Topical Brimonidine on Post Cataract Surgery Corneal Edema
NCT ID: NCT00800423
Last Updated: 2008-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
150 participants
INTERVENTIONAL
2009-01-31
2010-01-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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brimonidine
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)
Brimonidine Tartrate 0.2%
Brimonidine Tartrate 0.2% drops
1 drop twice a day for 1 month in the operated eye
2 tmolol
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)
Timolol maleate 0.5%
timolol maleate 0.5% drops
1 drop twice a day for 1 month in the operated eye
3
50 patients will not receive any additional drug to the usual medications after cataract surgery (corticosteroids and antibiotics drops)
No interventions assigned to this group
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* corneal edema (grade 2 to 3)
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Rabin Medical Center
OTHER
Responsible Party
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Rabin Medical Center
Principal Investigators
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Anat Robinson, MD
Role: PRINCIPAL_INVESTIGATOR
Rabin medical center, Clalit health services , Israel
Locations
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Rabin medical center ophthalmology deparment
Petah Tikva, , Israel
Countries
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Central Contacts
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Facility Contacts
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Weinberger Dov, MD
Role: primary
Omer bialer, MD
Role: backup
Other Identifiers
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5189
Identifier Type: -
Identifier Source: org_study_id