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Sponsors and Collaborators: |
Queen's University Glaucoma Research & Education Group |
Information provided by: | Queen's University |
ClinicalTrials.gov Identifier: | NCT00551902 |
In the treatment of glaucoma, trabeculectomy surgery provides a drainage system for the eye and allows for the lowering of the pressure inside the eye. The flow through the surgically created fistula determines the intraocular pressure. Titrating suture tightness is important to achieving the desired post-operative intraocular pressure. This process is not straightforward and intraocular pressures are often too high or too low post-operatively. The use of an anterior chamber infusion system to deliver fluid into the eye during trabeculectomy surgery may be of benefit in this process and may have other benefits as well which may result in better outcomes.
Thus, the hypothesis of this study is that the use of an anterior chamber infusion system improves success of trabeculectomy surgery.
Condition | Intervention | Phase |
Glaucoma |
Procedure: Trabeculectomy with anterior chamber infusion system Procedure: Trabeculectomy without anterior chamber infusion system |
Phase I |
Genetics Home Reference related topics: | early-onset glaucoma |
MedlinePlus related topics: | Glaucoma |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Effect of an Anterior Chamber Infusion System on Trabeculectomy Outcomes |
Estimated Enrollment: | 90 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Trabeculectomy with anterior chamber infusion system
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Procedure: Trabeculectomy with anterior chamber infusion system
Trabeculectomy with anterior chamber infusion system
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2: Active Comparator
Trabeculectomy without anterior chamber infusion system
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Procedure: Trabeculectomy without anterior chamber infusion system
Standard trabeculectomy surgery
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
One of the following diagnoses:
Exclusion Criteria:
Contact: Robert J Campbell, MD | (613) 544-3400 ext 3189 | rob.campbell@queensu.ca |
Canada, Ontario | |||||
Hotel Dieu Hospital, Queen's University | Recruiting | ||||
Kingston, Ontario, Canada, K7L 5G2 | |||||
Contact: Robert J Campbell, MD (613) 544-3400 ext 3189 rob.campbell@queensu.ca | |||||
Principal Investigator: Robert J Campbell, MD | |||||
Toronto Western Hospital, University of Toronto | Not yet recruiting | ||||
Toronto, Ontario, Canada | |||||
Contact: Graham E Trope, MD |
Queen's University |
Glaucoma Research & Education Group |
Principal Investigator: | Robert J Campbell, MD | Queen's University |
Responsible Party: | Queen's University ( Dr. Robert J Campbell ) |
Study ID Numbers: | RC-2 |
First Received: | October 29, 2007 |
Last Updated: | May 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00551902 |
Health Authority: | Canada: Ethics Review Committee |
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