MedTrace Logo

Prospective Randomized Study Comparing Ex-PRESS to Trabeculectomy

NCT01263561 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2014-12-09

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

PROCEDURE

ExPRESS shunt

ExPRESS miniature glaucoma drainage device

PROCEDURE

trabeculectomy

trabeculectomy filtering surgery

Sponsors & Collaborators

  • University of Toronto

    lead OTHER

Principal Investigators

  • Graham E Trope, Professor · University of Toronto

  • Yvonne M Buys, Professor · University of Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01263561 on ClinicalTrials.gov