Prospective Randomized Study Comparing Ex-PRESS to Trabeculectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Randomized Study Comparing Ex-PRESS to Trabeculectomy

Conditions
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Glaucoma

Intervention / Treatment
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* Procedure: ExPRESS shunt
* Procedure: trabeculectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 to 85 open-angle glaucoma uncontrolled medically intraocular pressure ≥ 18 mmHg trabeculectomy as the planned surgical procedure 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: trabeculectomy<br>trabeculectomy filtering surgery | Procedure: trabeculectomy<br>* trabeculectomy filtering surgery<br>|
| Experimental: ExPRESS<br>ExPRESS miniature glaucoma drainage device | Procedure: ExPRESS shunt<br>* ExPRESS miniature glaucoma drainage device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | 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. | 1 year post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glaucoma, filtration surgery, trabeculectomy, ExPRESS shunt