Status:
TERMINATED
Trabectome Versus Trabeculectomy With Mitomycin C in Patients With Open Angle Glaucoma
Lead Sponsor:
University of Alberta
Conditions:
Open Angle Glaucoma
Eligibility:
All Genders
40-85 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the efficacy and safety of Trabectome versus Trabeculectomy with adjunctive Mitomycin C, combined with cataract surgery, in patients with open angle glaucoma.
Detailed Description
Background: Trabeculectomy with adjunctive use of Mitomycin C (Trab MMC) is the standard incisional procedure to lower intraocular pressure (IOP) in adults with open angle glaucoma (OAG). Trab MMC has...
Eligibility Criteria
Inclusion
- Age 40-85 years
- Open angle glaucoma (including pseudo exfoliative glaucoma)
- Open angles (≥ Shaffer grade II)
- Inadequately controlled IOP requiring surgical intervention
- Visually significant cataract
- Willing to complete quality of life questionnaires
- Capable of informed consent and available for at least 1 year follow-up
Exclusion
- Any form of angle closure glaucoma
- Secondary open angle glaucomas
- Absence of clear angle landmarks on gonioscopy
- Other ocular disease that may affect assessments of visual acuity, visual field, or accurate tonometry
- Previous angle surgery or filtering procedure
- Steroid use within the preceding 3 months
- Presence of significant co-morbidities
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00901108
Start Date
November 1 2009
End Date
October 1 2015
Last Update
February 25 2016
Active Locations (1)
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1
Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H 3V9