Status:
COMPLETED
Comparison of Silicone and Porous Plate Ahmed Glaucoma Valves
Lead Sponsor:
Peter Netland, MD
Collaborating Sponsors:
New World Medical, Inc.
Conditions:
Glaucoma
Eligibility:
All Genders
18-80 years
Phase:
NA
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 27 2018
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT01883856
Start Date
February 1 2012
End Date
August 27 2018
Last Update
October 19 2020
Active Locations (1)
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1
University of Virginia
Charlottesville, Virginia, United States, 22908