search
Back to results

Prospective Randomized Study Comparing Ex-PRESS to Trabeculectomy

Primary Purpose

Glaucoma

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
ExPRESS shunt
trabeculectomy
Sponsored by
University of Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring glaucoma, filtration surgery, trabeculectomy, ExPRESS shunt

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Ophthalmology and Vision Sciences Toronto Westarn Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

trabeculectomy

ExPRESS

Arm Description

trabeculectomy filtering surgery

ExPRESS miniature glaucoma drainage device

Outcomes

Primary Outcome Measures

Intraocular Pressure
Success Rate (IOP Between 5-18 mmHg and 20% Reduction From Baseline) Without Glaucoma Medication

Secondary Outcome Measures

Complications
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.

Full Information

First Posted
December 14, 2010
Last Updated
December 7, 2014
Sponsor
University of Toronto
search

1. Study Identification

Unique Protocol Identification Number
NCT01263561
Brief Title
Prospective Randomized Study Comparing Ex-PRESS to Trabeculectomy
Official Title
Prospective Randomized Study Comparing Ex-PRESS to Trabeculectomy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
glaucoma, filtration surgery, trabeculectomy, ExPRESS shunt

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
trabeculectomy
Arm Type
Active Comparator
Arm Description
trabeculectomy filtering surgery
Arm Title
ExPRESS
Arm Type
Experimental
Arm Description
ExPRESS miniature glaucoma drainage device
Intervention Type
Procedure
Intervention Name(s)
ExPRESS shunt
Intervention Description
ExPRESS miniature glaucoma drainage device
Intervention Type
Procedure
Intervention Name(s)
trabeculectomy
Intervention Description
trabeculectomy filtering surgery
Primary Outcome Measure Information:
Title
Intraocular Pressure
Time Frame
1 year post surgery
Title
Success Rate (IOP Between 5-18 mmHg and 20% Reduction From Baseline) Without Glaucoma Medication
Time Frame
1 year post surgery
Secondary Outcome Measure Information:
Title
Complications
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.
Time Frame
1 year post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Graham E Trope, Professor
Organizational Affiliation
University of Toronto
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yvonne M Buys, Professor
Organizational Affiliation
University of Toronto
Official's Role
Study Director
Facility Information:
Facility Name
Department of Ophthalmology and Vision Sciences Toronto Westarn Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
26674779
Citation
Gonzalez-Rodriguez JM, Trope GE, Drori-Wagschal L, Jinapriya D, Buys YM. Comparison of trabeculectomy versus Ex-PRESS: 3-year follow-up. Br J Ophthalmol. 2016 Sep;100(9):1269-73. doi: 10.1136/bjophthalmol-2015-307161. Epub 2015 Dec 16.
Results Reference
derived

Learn more about this trial

Prospective Randomized Study Comparing Ex-PRESS to Trabeculectomy

We'll reach out to this number within 24 hrs