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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
December 14, 2010
December 20, 2010
December 1, 2014
December 9, 2014
December 9, 2014
April 2009
April 2013   (Final data collection date for primary outcome measure)
  • 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 ]
  • Intraocular Pressure [ Time Frame: 1 year post surgery ]
  • success rate (IOP between 5-18 mmHg and 20% reduction from baseline) [ Time Frame: 1 year post surgery ]
Complete list of historical versions of study NCT01263561 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Prospective Randomized Study Comparing Ex-PRESS to Trabeculectomy
Prospective Randomized Study Comparing Ex-PRESS to Trabeculectomy
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Glaucoma
  • Procedure: ExPRESS shunt
    ExPRESS miniature glaucoma drainage device
  • Procedure: trabeculectomy
    trabeculectomy filtering surgery
  • Active Comparator: trabeculectomy
    trabeculectomy filtering surgery
    Intervention: Procedure: trabeculectomy
  • Experimental: ExPRESS
    ExPRESS miniature glaucoma drainage device
    Intervention: Procedure: ExPRESS shunt
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
April 2013
April 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01263561
07-0888-A
No
Not Provided
Not Provided
Yvonne Buys, University of Toronto
University of Toronto
Not Provided
Study Director: Graham E Trope, Professor University of Toronto
Study Director: Yvonne M Buys, Professor University of Toronto
University of Toronto
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP