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Effect of an Anterior Chamber Infusion System on Trabeculectomy Outcomes

Primary Purpose

Glaucoma

Status

Withdrawn

Phase

Phase 1

Locations

Canada

Study Type

Interventional

Intervention

Trabeculectomy with anterior chamber infusion system

Trabeculectomy without anterior chamber infusion system

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Glaucoma, trabeculectomy, anterior chamber maintainer, anterior chamber infusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hotel Dieu Hospital, Queen's University
Toronto Western Hospital, University of Toronto

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Trabeculectomy with anterior chamber infusion system

Trabeculectomy without anterior chamber infusion system

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Need for laser suture lysis

complications: aqueous misdirection, suprachoroidal hemorrhage, anterior chamber shallowing

Full Information

NCT ID

NCT00551902

First Posted

October 29, 2007

Last Updated

September 21, 2015

Sponsor

Queen's University

Collaborators

Glaucoma Research & Education Group

1. Study Identification

Unique Protocol Identification Number

NCT00551902

Brief Title

Effect of an Anterior Chamber Infusion System on Trabeculectomy Outcomes

Official Title

Effect of an Anterior Chamber Infusion System on Trabeculectomy Outcomes

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Withdrawn

Why Stopped

Efficacy study indicated that further study is not warranted

Study Start Date

September 2007 (undefined)

Primary Completion Date

March 2010 (Actual)

Study Completion Date

March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Queen's University

Collaborators

Glaucoma Research & Education Group

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma

Keywords

Glaucoma, trabeculectomy, anterior chamber maintainer, anterior chamber infusion

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Trabeculectomy with anterior chamber infusion system

Arm Title

Arm Type

Active Comparator

Arm Description

Trabeculectomy without anterior chamber infusion system

Intervention Type

Procedure

Intervention Name(s)

Trabeculectomy with anterior chamber infusion system

Intervention Description

Trabeculectomy with anterior chamber infusion system

Intervention Type

Procedure

Intervention Name(s)

Trabeculectomy without anterior chamber infusion system

Intervention Description

Standard trabeculectomy surgery

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

Need for laser suture lysis

Time Frame

any point post operatively

Title

complications: aqueous misdirection, suprachoroidal hemorrhage, anterior chamber shallowing

Time Frame

any time post operatively

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert J Campbell, MD

Organizational Affiliation

Queen's University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hotel Dieu Hospital, Queen's University

City

Kingston

State/Province

Ontario

ZIP/Postal Code

K7L 5G2

Country

Canada

Facility Name

Toronto Western Hospital, University of Toronto

City

Toronto

State/Province

Ontario

Country

Canada

12. IPD Sharing Statement

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Effect of an Anterior Chamber Infusion System on Trabeculectomy Outcomes

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