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Comparison of Silicone and Porous Plate Ahmed Glaucoma Valves

Primary Purpose

Glaucoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Silicone plate Ahmed Glaucoma Valve (Model FP7)
Porous Plate Ahmed Glaucoma Valve (Model M4)
Sponsored by
Peter Netland, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Refractory Glaucoma, Intractable Glaucoma, Primary Open Angle Glaucoma, Neovascular Glaucoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of Virginia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Silicone Plate Ahmed Glaucoma Valve

Porous Plate Ahmed Glaucoma Valve

Arm Description

Silicone plate Ahmed Glaucoma Valve

Porous Plate Ahmed Glaucoma Valve

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 18, 2013
Last Updated
September 21, 2020
Sponsor
Peter Netland, MD
Collaborators
New World Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01883856
Brief Title
Comparison of Silicone and Porous Plate Ahmed Glaucoma Valves
Official Title
Comparison of Silicone and Porous Plate Ahmed Glaucoma Valves
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
September 10, 2017 (Actual)
Study Completion Date
August 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Peter Netland, MD
Collaborators
New World Medical, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Refractory Glaucoma, Intractable Glaucoma, Primary Open Angle Glaucoma, Neovascular Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Silicone Plate Ahmed Glaucoma Valve
Arm Type
Active Comparator
Arm Description
Silicone plate Ahmed Glaucoma Valve
Arm Title
Porous Plate Ahmed Glaucoma Valve
Arm Type
Experimental
Arm Description
Porous Plate Ahmed Glaucoma Valve
Intervention Type
Device
Intervention Name(s)
Silicone plate Ahmed Glaucoma Valve (Model FP7)
Intervention Description
This intervention is conducted as a surgical intervention.
Intervention Type
Device
Intervention Name(s)
Porous Plate Ahmed Glaucoma Valve (Model M4)
Intervention Description
This intervention is conducted as a surgical intervention.
Primary Outcome Measure Information:
Title
Change in Intraocular Pressure
Description
The primary endpoint is the mean intraocular pressure in the porous plate group as compared to the silicone plate group.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Anti-Glaucoma Medications
Description
The mean number of anti-glaucoma medications in the porous plate group as compared to the silicone plate group at 12 months.
Time Frame
12 months
Title
Surgical Success
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter A Netland, MD, PhD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Described in study results - https://pubmed.ncbi.nlm.nih.gov/32765127/
Citations:
PubMed Identifier
32765127
Citation
Roa TM, Netland PA, Costa VP, Sarkisian SR Jr, Al-Aswad LA, Moster MR, Ahmed IIK. Comparison of Silicone- and Porous-Plate Ahmed Glaucoma Valves. Med Devices (Auckl). 2020 Jul 16;13:213-221. doi: 10.2147/MDER.S258498. eCollection 2020.
Results Reference
result
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/32765127/
Description
Study results indexed on Pub Med

Learn more about this trial

Comparison of Silicone and Porous Plate Ahmed Glaucoma Valves

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