Prospective Randomized Study Comparing Ex-PRESS to Trabeculectomy

Not Applicable

Completed

• Conditions: Glaucoma
• Interventions: Procedure: ExPRESS shunt; Procedure: trabeculectomy

• Registration Number: NCT01263561
• Lead Sponsor: University of Toronto

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 Timeline

• Study Start: 2009-04
• Study First Submitted: 2010-12-14
• Study First Submitted QC: 2010-12-17
• Study First Posted: 2010-12-20
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2014-12
• Results First Submitted: 2014-12-01
• Results First Submitted QC: 2014-12-07
• Last Update Submitted: 2014-12-07
• Results First Posted: 2014-12-09
• Last Update Posted: 2014-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• age 18 to 85
• open-angle glaucoma uncontrolled medically
• intraocular pressure ≥ 18 mmHg
• trabeculectomy as the planned surgical procedure

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ExPRESS	ExPRESS shunt	ExPRESS miniature glaucoma drainage device
trabeculectomy	trabeculectomy	trabeculectomy filtering surgery

Primary Outcome Measures

Name	Time	Method
Intraocular Pressure	1 year post surgery
Success Rate (IOP Between 5-18 mmHg and 20% Reduction From Baseline) Without Glaucoma Medication	1 year post surgery

Secondary Outcome Measures

Name	Time	Method
Complications	1 year post surgery	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.

Trial Locations

Locations (1)

Department of Ophthalmology and Vision Sciences Toronto Westarn Hospital; 🇨🇦 Toronto, Ontario, Canada