Prospective Randomized Study Comparing Ex-PRESS to Trabeculectomy

December 7, 2014 updated by: Yvonne Buys, University of Toronto
Prospective randomized study comparing guarded Ex-PRESS to trabeculectomy. Primary outcome: IOP and success (complete success defined as IOP between 5-18 mmHg and 20% reduction from baseline without medication or additional glaucoma surgery and qualified success defined as IOP between 5-18 mmHg and 20% reduction from baseline with or without glaucoma medication but no additional glaucoma surgery). Secondary outcomes: number of glaucoma medications, visual acuity, number of complications, corneal pachymetry and corneal endothelial cell counts.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Complications will be evaluated for the intra-operative, early post-operative (up until 1 month) and late post-operative (from 1 month to 1 year) periods. In addition complications will be evaluated as severe (defined as a permanent reduction in vision or complications requiring a surgical intervention) and not severe (complications which resolve with conservative management). As an individual subject may have more than one complication, the number of complications will be compared between the two surgical groups.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

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
      • Toronto, Ontario, Canada, M5T 2S8
        • Department of Ophthalmology and Vision Sciences Toronto Westarn Hospital

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 to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age 18 to 85
  • open-angle glaucoma uncontrolled medically
  • intraocular pressure ≥ 18 mmHg
  • trabeculectomy as the planned surgical procedure

Exclusion Criteria:

  • any previous ocular incisional surgery with the exception of previous clear
  • cornea cataract surgery
  • uveitis
  • vitreous present in anterior chamber
  • patient unwilling or unable to accept randomization or to give consent or to attend the follow up visits

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: trabeculectomy
trabeculectomy filtering surgery
Procedure: trabeculectomy
trabeculectomy filtering surgery
EXPERIMENTAL: ExPRESS
ExPRESS miniature glaucoma drainage device
Procedure: ExPRESS shunt
ExPRESS miniature glaucoma drainage device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intraocular Pressure
Time Frame: 1 year post surgery
1 year post surgery
Success Rate (IOP Between 5-18 mmHg and 20% Reduction From Baseline) Without Glaucoma Medication
Time Frame: 1 year post surgery
1 year post surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: 1 year post surgery
Complications will be evaluated for the intra-operative, early post-operative (up until 1 month) and late post-operative (from 1 month to 1 year) periods. In addition complications will be evaluated as severe (defined as a permanent reduction in vision or complications requiring a surgical intervention) and not severe (complications which resolve with conservative management). As an individual subject may have more than one complication, the number of complications will be compared between the two surgical groups.
1 year post surgery

Collaborators and Investigators

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

Sponsor

University of Toronto

Investigators

  • Study Director: Graham E Trope, Professor, University of Toronto
  • Study Director: Yvonne M Buys, Professor, University of Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2009

Primary Completion (ACTUAL)

April 1, 2013

Study Completion (ACTUAL)

April 1, 2013

Study Registration Dates

First Submitted

December 14, 2010

First Submitted That Met QC Criteria

December 17, 2010

First Posted (ESTIMATE)

December 20, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

December 9, 2014

Last Update Submitted That Met QC Criteria

December 7, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-0888-A

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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