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NCT01883856 Clinical Trial

Comparison of Silicone and Porous Plate Ahmed Glaucoma Valves

Glaucoma Clinical Trial

Official title:
Comparison of Silicone and Porous Plate Ahmed Glaucoma Valves

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01883856
Other study ID # 16051
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2012
Est. completion date August 27, 2018

Study information
Verified date September 2020
Source University of Virginia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 52
Est. completion date August 27, 2018
Est. primary completion date September 10, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Silicone plate Ahmed Glaucoma Valve (Model FP7)
This intervention is conducted as a surgical intervention.
• Porous Plate Ahmed Glaucoma Valve (Model M4)
This intervention is conducted as a surgical intervention.

Locations
Country Name City State
United States University of Virginia Charlottesville Virginia

Sponsors (2)
Lead Sponsor Collaborator
Peter Netland, MD New World Medical, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Intraocular Pressure The primary endpoint is the mean intraocular pressure in the porous plate group as compared to the silicone plate group. 12 months
Secondary 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. 12 months
Secondary 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. 12 months
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