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Clinical Trials/NCT00551902
NCT00551902
Withdrawn
Phase 1

Effect of an Anterior Chamber Infusion System on Trabeculectomy Outcomes

Queen's University2 sites in 1 countrySeptember 2007
ConditionsGlaucoma

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Glaucoma
Sponsor
Queen's University
Locations
2
Primary Endpoint
surgical success: intraocular pressure lowered by 30% and functional filtering bleb
Status
Withdrawn
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2007
End Date
March 2010
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Robert Campbell

Principal Investigator

Queen's University

Eligibility 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

Outcomes

Primary Outcomes

surgical success: intraocular pressure lowered by 30% and functional filtering bleb

Time Frame: 2 weeks, 1 month, 3 months, 6 months and 1 year post surgery

Secondary Outcomes

  • Need for laser suture lysis(any point post operatively)
  • complications: aqueous misdirection, suprachoroidal hemorrhage, anterior chamber shallowing(any time post operatively)

Study Sites (2)

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