Effect of an Anterior Chamber Infusion System on Trabeculectomy Outcomes

September 21, 2015 updated by: Dr. Robert Campbell, Queen's University
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L 5G2
        • Hotel Dieu Hospital, Queen's University
      • Toronto, Ontario, Canada
        • Toronto Western Hospital, University of Toronto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen's University

Collaborators

Glaucoma Research & Education Group

Investigators

  • Principal Investigator: Robert J Campbell, MD, Queen's University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

October 29, 2007

First Submitted That Met QC Criteria

October 29, 2007

First Posted (Estimate)

October 31, 2007

Study Record Updates

Last Update Posted (Estimate)

September 23, 2015

Last Update Submitted That Met QC Criteria

September 21, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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