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Completed

NCT Number: NCT01883856

Comparison of Silicone and Porous Plate Ahmed Glaucoma Valves

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.

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Key information

Conditions

Glaucoma Eye Diseases Glaucoma, Neovascular Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia

Charlottesville, Virginia, 22908, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Silicone plate Ahmed Glaucoma Valve (Model FP7)

Device

This intervention is conducted as a surgical intervention.

Porous Plate Ahmed Glaucoma Valve (Model M4)

Device

This intervention is conducted as a surgical intervention.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Peter Netland, MD

Other

Collaborators

  • New World Medical, Inc.

Registry information

Important dates

Study start
2012
Primary completion
2017
Study completion
2018
First posted
Jun 21, 2013
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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