Effect of an Anterior Chamber Infusion System on Trabeculectomy Outcomes

Sponsor
Queen's University (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00551902
Collaborator
Glaucoma Research & Education Group (Other)
0
2
2
30
0
0

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
  • Procedure: Trabeculectomy with anterior chamber infusion system
  • Procedure: Trabeculectomy without anterior chamber infusion system
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

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of an Anterior Chamber Infusion System on Trabeculectomy Outcomes
Study Start Date :
Sep 1, 2007
Actual Primary Completion Date :
Mar 1, 2010
Actual Study Completion Date :
Mar 1, 2010

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

  1. 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

  1. Need for laser suture lysis [any point post operatively]

  2. complications: aqueous misdirection, suprachoroidal hemorrhage, anterior chamber shallowing [any time post operatively]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Responsible Party:
Dr. Robert Campbell, Principal Investigator, Queen's University
ClinicalTrials.gov Identifier:
NCT00551902
Other Study ID Numbers:
  • RC-2
First Posted:
Oct 31, 2007
Last Update Posted:
Sep 23, 2015
Last Verified:
Sep 1, 2015
Keywords provided by Dr. Robert Campbell, Principal Investigator, Queen's University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 23, 2015