Effect of an Anterior Chamber Infusion System on Trabeculectomy Outcomes
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 1 Trabeculectomy with anterior chamber infusion system |
Procedure: Trabeculectomy with anterior chamber infusion system
Trabeculectomy with anterior chamber infusion system
|
Active Comparator: 2 Trabeculectomy without anterior chamber infusion system |
Procedure: Trabeculectomy without anterior chamber infusion system
Standard trabeculectomy surgery
|
Outcome Measures
Primary Outcome Measures
- surgical success: intraocular pressure lowered by 30% and functional filtering bleb [2 weeks, 1 month, 3 months, 6 months and 1 year post surgery]
Secondary Outcome Measures
- Need for laser suture lysis [any point post operatively]
- complications: aqueous misdirection, suprachoroidal hemorrhage, anterior chamber shallowing [any time post operatively]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
18 years of age
-
One of the following diagnoses:
-
primary open angle glaucoma
-
chronic angle closure glaucoma
-
pseudo exfoliation glaucoma
-
pigment dispersion glaucoma
Exclusion Criteria:
- unable to provide consent or return for follow up
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Hotel Dieu Hospital, Queen's University | Kingston | Ontario | Canada | K7L 5G2 |
2 | Toronto Western Hospital, University of Toronto | Toronto | Ontario | Canada |
Sponsors and Collaborators
- Queen's University
- Glaucoma Research & Education Group
Investigators
- Principal Investigator: Robert J Campbell, MD, Queen's University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RC-2