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Prospective Randomized Study Comparing Ex-PRESS to Trabeculectomy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Yvonne Buys, University of Toronto
ClinicalTrials.gov Identifier:
NCT01263561
First received: December 14, 2010
Last updated: March 15, 2013
Last verified: March 2013
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Study Comparing Ex-PRESS to Trabeculectomy

Resource links provided by NLM:

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • intraocular pressure [ Time Frame: 1 year post surgery ] [ Designated as safety issue: No ]
  • success rate (IOP between 5-18 mmHg and 20% reduction from baseline) [ Time Frame: 1 year post surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • complications [ Time Frame: 1 year post surgery ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 54
Study Start Date: April 2009
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
trabeculectomy
trabeculectomy filtering surgery
 Procedure: trabeculectomy
trabeculectomy filtering surgery
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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Yvonne Buys, MD, FRCSC; Professor, University of Toronto
ClinicalTrials.gov Identifier: NCT01263561     History of Changes
Other Study ID Numbers: 07-0888-A
Study First Received: December 14, 2010
Last Updated: March 15, 2013
Health Authority: Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on June 18, 2013