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Prospective Randomized Study Comparing Ex-PRESS to Trabeculectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01263561
First Posted: December 20, 2010
Last Update Posted: December 9, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yvonne Buys, University of Toronto
  Purpose
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.

Condition Intervention
Glaucoma Procedure: ExPRESS shunt Procedure: trabeculectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Study Comparing Ex-PRESS to Trabeculectomy

Resource links provided by NLM:


Further study details as provided by Yvonne Buys, University of Toronto:

Primary Outcome Measures:
  • Intraocular Pressure [ Time Frame: 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 ]

Secondary Outcome Measures:
  • 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.


Enrollment: 64
Study Start Date: April 2009
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01263561


Locations
Canada, Ontario
Department of Ophthalmology and Vision Sciences Toronto Westarn Hospital
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
University of Toronto
Investigators
Study Director: Graham E Trope, Professor University of Toronto
Study Director: Yvonne M Buys, Professor University of Toronto
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yvonne Buys, MD, FRCSC; Professor, University of Toronto
ClinicalTrials.gov Identifier: NCT01263561     History of Changes
Other Study ID Numbers: 07-0888-A
First Submitted: December 14, 2010
First Posted: December 20, 2010
Results First Submitted: December 1, 2014
Results First Posted: December 9, 2014
Last Update Posted: December 9, 2014
Last Verified: December 2014

Keywords provided by Yvonne Buys, University of Toronto:
glaucoma
filtration surgery
trabeculectomy
ExPRESS shunt

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases