Status:
COMPLETED
Prospective Randomized Study Comparing Ex-PRESS to Trabeculectomy
Lead Sponsor:
University of Toronto
Conditions:
Glaucoma
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
Prospective randomized study comparing guarded Ex-PRESS to trabeculectomy. Primary outcome: IOP and success (complete success defined as IOP between 5-18 mmHg and 20% reduction from baseline without m...
Detailed Description
Complications will be evaluated for the intra-operative, early post-operative (up until 1 month) and late post-operative (from 1 month to 1 year) periods. In addition complications will be evaluated a...
Eligibility Criteria
Inclusion
- age 18 to 85
- open-angle glaucoma uncontrolled medically
- intraocular pressure ≥ 18 mmHg
- trabeculectomy as the planned surgical procedure
Exclusion
- any previous ocular incisional surgery with the exception of previous clear
- cornea cataract surgery
- uveitis
- vitreous present in anterior chamber
- patient unwilling or unable to accept randomization or to give consent or to attend the follow up visits
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT01263561
Start Date
April 1 2009
End Date
April 1 2013
Last Update
December 9 2014
Active Locations (1)
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1
Department of Ophthalmology and Vision Sciences Toronto Westarn Hospital
Toronto, Ontario, Canada, M5T 2S8