NCT01263561

Prospective Randomized Study Comparing Ex-PRESS to Trabeculectomy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: University of Toronto · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glaucoma

Interventions

Type	Name	Description
PROCEDURE	ExPRESS shunt	ExPRESS miniature glaucoma drainage device
PROCEDURE	trabeculectomy	trabeculectomy filtering surgery

Timeline

• Start date: 2009-04-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2010-12-20
• Last updated: 2014-12-09
• Results posted: 2014-12-09

Locations

1 site across 1 country: Canada