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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

December 14, 2010
March 15, 2013
April 2009
April 2013   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01263561 on ClinicalTrials.gov Archive Site
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.
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Glaucoma
  • Procedure: ExPRESS shunt
    ExPRESS miniature glaucoma drainage device
  • Procedure: trabeculectomy
    trabeculectomy filtering surgery
  • trabeculectomy
    trabeculectomy filtering surgery
    Intervention: Procedure: trabeculectomy
  • ExPRESS
    ExPRESS miniature glaucoma drainage device
    Intervention: Procedure: ExPRESS shunt
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
54
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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01263561
07-0888-A
No
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
March 2013

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