Effect of an Anterior Chamber Infusion System on Trabeculectomy Outcomes

NCT ID: NCT00551902

Last Updated: 2015-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2010-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glaucoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Trabeculectomy with anterior chamber infusion system

Group Type EXPERIMENTAL

Trabeculectomy with anterior chamber infusion system

Intervention Type PROCEDURE

Trabeculectomy with anterior chamber infusion system

2

Trabeculectomy without anterior chamber infusion system

Group Type ACTIVE_COMPARATOR

Trabeculectomy without anterior chamber infusion system

Intervention Type PROCEDURE

Standard trabeculectomy surgery

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Trabeculectomy with anterior chamber infusion system

Trabeculectomy with anterior chamber infusion system

Intervention Type PROCEDURE

Trabeculectomy without anterior chamber infusion system

Standard trabeculectomy surgery

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Glaucoma Research & Education Group

OTHER

Sponsor Role collaborator

Queen's University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. Robert Campbell

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Robert J Campbell, MD

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hotel Dieu Hospital, Queen's University

Kingston, Ontario, Canada

Site Status

Toronto Western Hospital, University of Toronto

Toronto, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RC-2

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Canadian Glaucoma Study
NCT00262626 TERMINATED NA