Comparison of Silicone and Porous Plate Ahmed Glaucoma Valves

Study Overview
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Brief Summary
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The purpose of this study is to evaluate and compare the clinical outcomes after implantation of the porous plate (polyethylene) (Model M4) Ahmed Glaucoma Valve with the silicone plate Ahmed Glaucoma Valve (Model FP7) in participants with refractory glaucoma.

Detailed Description
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The purpose of this study is to evaluate and compare the clinical outcomes after implantation of the porous plate (polyethylene) (Model M4) Ahmed Glaucoma Valve with the silicone plate Ahmed Glaucoma Valve (Model FP7) in participants with refractory glaucoma. Participation will last for 12 months.

Official Title
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Comparison of Silicone and Porous Plate Ahmed Glaucoma Valves

Conditions
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Glaucoma

Intervention / Treatment
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* Device: Silicone plate Ahmed Glaucoma Valve (Model FP7)
* Device: Porous Plate Ahmed Glaucoma Valve (Model M4)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female of any race ≥ 18 years and ≤ 80 years of age. Diagnosis of intractable glaucoma in the study eye, with the exception of silicone oil endotamponade induced glaucoma, which has not responded to conventional medical and surgical therapy. Elevated intraocular pressure > 21 mmHg in the study eye. Two consecutive measurements using Goldmann Applanation Tonometry will be obtained and the mean of those two measurements will be considered the subject's baseline intraocular pressure. Subject is a candidate for surgery in the study eye with a glaucoma drainage device. Subject is willing and able to sign the informed consent. Exclusion Criteria: Diagnosis of silicone oil endotamponade induced glaucoma in the study eye. History of prior drainage implant surgery in the study eye. History of cyclophotocoagulation of the study eye. Pregnancy. Prisoner.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Silicone Plate Ahmed Glaucoma Valve<br>Silicone plate Ahmed Glaucoma Valve | Device: Silicone plate Ahmed Glaucoma Valve (Model FP7)<br>* This intervention is conducted as a surgical intervention.<br>|
| Experimental: Porous Plate Ahmed Glaucoma Valve<br>Porous Plate Ahmed Glaucoma Valve | Device: Porous Plate Ahmed Glaucoma Valve (Model M4)<br>* This intervention is conducted as a surgical intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Intraocular Pressure | The primary endpoint is the mean intraocular pressure in the porous plate group as compared to the silicone plate group. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-Glaucoma Medications | The mean number of anti-glaucoma medications in the porous plate group as compared to the silicone plate group at 12 months. | 12 months | 
| Surgical Success | Surgical success in the porous plate group as compared to the silicone plate group at 12 months. Surgical success was defined as intraocular pressure of ≤5 mmHg or ≥21 mmHg (with or without glaucoma medications), with no loss of light perception, and no additional glaucoma procedures. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Refractory Glaucoma, Intractable Glaucoma, Primary Open Angle Glaucoma, Neovascular Glaucoma