Comparison of Silicone and Porous Plate Ahmed Glaucoma Valves

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2018-08-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Outcome of Ahmed Glaucoma Valve in Difficult Glaucoma Cases

NCT04214847

Glaucoma, Open-Angle Glaucoma Secondary Glaucoma, Neovascular

COMPLETED NA

Baerveldt (BGI) Valve Versus Ahmed(AGV) Valve in Management of Difficult Glaucoma Cases

NCT04215575

Glaucoma, Open-Angle Glaucoma Secondary Glaucoma, Neovascular +1 more

COMPLETED NA

Ahmed Glaucoma Valve Implantation; Graft-Free Short Tunnel Small Flap Versus Scleral Patch Graft

NCT03551834

Glaucoma

UNKNOWN PHASE1/PHASE2

Paul Glaucoma Implant Versus Ahmed Glaucoma Valve in Childhood Glaucoma

NCT05797350

Glaucoma

UNKNOWN NA

Comparison of Efficacy Between Silicone Ahmed Glaucoma Valves and Second Trabeculectomy in Glaucoma Patients

NCT00665756

Open Angle Glaucoma

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glaucoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Silicone Plate Ahmed Glaucoma Valve

Silicone plate Ahmed Glaucoma Valve

Group Type ACTIVE_COMPARATOR

Silicone plate Ahmed Glaucoma Valve (Model FP7)

Intervention Type DEVICE

This intervention is conducted as a surgical intervention.

Porous Plate Ahmed Glaucoma Valve

Group Type EXPERIMENTAL

Porous Plate Ahmed Glaucoma Valve (Model M4)

Intervention Type DEVICE

This intervention is conducted as a surgical intervention.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Silicone plate Ahmed Glaucoma Valve (Model FP7)

This intervention is conducted as a surgical intervention.

Intervention Type DEVICE

Porous Plate Ahmed Glaucoma Valve (Model M4)

This intervention is conducted as a surgical intervention.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No