Effect of an Anterior Chamber Infusion System on Trabeculectomy Outcomes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of an Anterior Chamber Infusion System on Trabeculectomy Outcomes

Conditions
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Glaucoma

Intervention / Treatment
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* Procedure: Trabeculectomy with anterior chamber infusion system
* Procedure: Trabeculectomy without anterior chamber infusion system


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Trabeculectomy with anterior chamber infusion system | Procedure: Trabeculectomy with anterior chamber infusion system<br>* Trabeculectomy with anterior chamber infusion system<br>|
| Active Comparator: 2<br>Trabeculectomy without anterior chamber infusion system | Procedure: Trabeculectomy without anterior chamber infusion system<br>* Standard trabeculectomy surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for laser suture lysis |  | any point post operatively | 
| complications: aqueous misdirection, suprachoroidal hemorrhage, anterior chamber shallowing |  | any time post operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glaucoma, trabeculectomy, anterior chamber maintainer, anterior chamber infusion