Comparison of Silicone and Porous Plate Ahmed Glaucoma Valves

Not Applicable

Completed

• Conditions: Glaucoma
• Interventions: Device: Silicone plate Ahmed Glaucoma Valve (Model FP7); Device: Porous Plate Ahmed Glaucoma Valve (Model M4)

• Registration Number: NCT01883856
• Lead Sponsor: Peter Netland, MD

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 Timeline

• Study Start: 2012-02
• Study First Submitted: 2013-06-18
• Study First Submitted QC: 2013-06-18
• Study First Posted: 2013-06-21
• Primary Completion: 2017-09-10
• Study Completion: 2018-08-27
• Results First Submitted: 2020-08-25
• Results First Submitted QC: 2020-08-25
• Status Verified: 2020-09
• Results First Posted: 2020-09-18
• Last Update Submitted: 2020-09-21
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Silicone Plate Ahmed Glaucoma Valve	Silicone plate Ahmed Glaucoma Valve (Model FP7)	Silicone plate Ahmed Glaucoma Valve
Porous Plate Ahmed Glaucoma Valve	Porous Plate Ahmed Glaucoma Valve (Model M4)	Porous Plate Ahmed Glaucoma Valve

Primary Outcome Measures

Name	Time	Method
Change in Intraocular Pressure	12 months	The primary endpoint is the mean intraocular pressure in the porous plate group as compared to the silicone plate group.

Secondary Outcome Measures

Name	Time	Method
Anti-Glaucoma Medications	12 months	The mean number of anti-glaucoma medications in the porous plate group as compared to the silicone plate group at 12 months.
Surgical Success	12 months	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.

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States