Comparison of Silicone and Porous Plate Ahmed Glaucoma Valves

September 21, 2020 updated by: Peter Netland, MD
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Silicone Plate Ahmed Glaucoma Valve
Silicone plate Ahmed Glaucoma Valve
Device: Silicone plate Ahmed Glaucoma Valve (Model FP7)
This intervention is conducted as a surgical intervention.
EXPERIMENTAL: Porous Plate Ahmed Glaucoma Valve
Device: Porous Plate Ahmed Glaucoma Valve (Model M4)
This intervention is conducted as a surgical intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti-Glaucoma Medications
Time Frame: 12 months
The mean number of anti-glaucoma medications in the porous plate group as compared to the silicone plate group at 12 months.
12 months
Surgical Success
Time Frame: 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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peter Netland, MD

Collaborators

New World Medical, Inc.

Investigators

  • Principal Investigator: Peter A Netland, MD, PhD, University of Virginia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (ACTUAL)

September 10, 2017

Study Completion (ACTUAL)

August 27, 2018

Study Registration Dates

First Submitted

June 18, 2013

First Submitted That Met QC Criteria

June 18, 2013

First Posted (ESTIMATE)

June 21, 2013

Study Record Updates

Last Update Posted (ACTUAL)

October 19, 2020

Last Update Submitted That Met QC Criteria

September 21, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16051

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Described in study results - https://pubmed.ncbi.nlm.nih.gov/32765127/

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Glaucoma

Clinical Trials on Silicone plate Ahmed Glaucoma Valve (Model FP7)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lebanon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe