Ignite Creation Date:
2025-12-24 @ 12:53 PM
Ignite Modification Date:
2025-12-28 @ 9:30 AM
Study NCT ID:
NCT01263561
Status:
COMPLETED
Last Update Posted:
2014-12-09
First Post:
2010-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prospective Randomized Study Comparing Ex-PRESS to Trabeculectomy
Sponsor:
University of Toronto
Organization:
Study Overview
Official Title:
Prospective Randomized Study Comparing Ex-PRESS to Trabeculectomy
Status:
COMPLETED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: