Comparison of Silicone and Porous Plate Ahmed Glaucoma Valves
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 52
- Locations
- 2
- Primary Endpoint
- Change in Intraocular Pressure
Study Overview
Brief Summary
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
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Change in Intraocular Pressure
Time Frame: 12 months
The primary endpoint is the mean intraocular pressure in the porous plate group as compared to the silicone plate group.
Secondary Outcomes
- Anti-Glaucoma Medications(12 months)
- Surgical Success(12 months)
Investigators
Peter Netland, MD
Chair, Department of Ophthalmology
University of Virginia