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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
This intervention is conducted as a surgical intervention.
This intervention is conducted as a surgical intervention.
University of Virginia
Charlottesville, Virginia, United States
Change in Intraocular Pressure
The primary endpoint is the mean intraocular pressure in the porous plate group as compared to the silicone plate group.
Time frame: 12 months
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.
Time frame: 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.
Time frame: 12 months
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