Effect of an Anterior Chamber Infusion System on Trabeculectomy Outcomes

Phase 1

Withdrawn

• Conditions: Glaucoma
• Interventions: Procedure: Trabeculectomy without anterior chamber infusion system; Procedure: Trabeculectomy with anterior chamber infusion system

• Registration Number: NCT00551902
• Lead Sponsor: Queen's University

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.

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 Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-10-29
• Study First Submitted QC: 2007-10-29
• Study First Posted: 2007-10-31
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-21
• Last Update Posted: 2015-09-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Trabeculectomy without anterior chamber infusion system	Trabeculectomy without anterior chamber infusion system
1	Trabeculectomy with anterior chamber infusion system	Trabeculectomy with anterior chamber infusion system

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Need for laser suture lysis	any point post operatively
complications: aqueous misdirection, suprachoroidal hemorrhage, anterior chamber shallowing	any time post operatively

Trial Locations

Locations (2)

Hotel Dieu Hospital, Queen's University; 🇨🇦 Kingston, Ontario, Canada

Toronto Western Hospital, University of Toronto; 🇨🇦 Toronto, Ontario, Canada