CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 64 enrolled
Drug / intervention
ExPRESS shunt +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01263561
NCT01263561N/ACompleted
CompareCT.gov

Prospective Randomized Study Comparing Ex-PRESS to Trabeculectomy

University of Toronto·interventional·Posted Dec 20, 2010·Updated Dec 9, 2014

In Brief

A clinical study evaluating ExPRESS shunt and trabeculectomy for Glaucoma. Completed, enrolled 64 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlaucoma
CountriesCanada
Collaborators--

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 20, 2010
Enrollment StartApr 1, 2009
Primary CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 15.5 years ago

Interventions

ExPRESS shuntprocedure

ExPRESS miniature glaucoma drainage device

trabeculectomyprocedure

trabeculectomy filtering surgery