Comparison of Silicone and Porous Plate Ahmed Glaucoma Valves

Peter Netland, MD

Status: Completed

Conditions: Glaucoma

Treatments: Device: Silicone plate Ahmed Glaucoma Valve (Model FP7); Device: Porous Plate Ahmed Glaucoma Valve (Model M4)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01883856

16051

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Silicone Plate Ahmed Glaucoma Valve

Active Comparator group

Description:

Silicone plate Ahmed Glaucoma Valve

Treatment:

Device: Silicone plate Ahmed Glaucoma Valve (Model FP7)

Porous Plate Ahmed Glaucoma Valve

Experimental group

Description:

Porous Plate Ahmed Glaucoma Valve

Treatment:

Device: Porous Plate Ahmed Glaucoma Valve (Model M4)