Comparison of Silicone and Porous Plate Ahmed Glaucoma Valves

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of Virginia
Sponsor:
Collaborator:
New World Medical
Information provided by (Responsible Party):
University of Virginia
ClinicalTrials.gov Identifier:
NCT01883856
First received: June 18, 2013
Last updated: June 20, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Refractory Glaucoma
Intractable Glaucoma
Device: Silicone plate Ahmed Glaucoma Valve (Model FP7)
Device: Porous Plate Ahmed Glaucoma Valve (Model M4)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Silicone and Porous Plate Ahmed Glaucoma Valves

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Change in Intraocular Pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The mean number of anti-glaucoma medications in the porous plate group as compared to the silicone plate group at 12 months.

  • Surgical Success [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Surgical success in the porous plate group as compared to the silicone plate group at 12 months.


Estimated Enrollment: 88
Study Start Date: February 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Silicone Plate Ahmed Glaucoma Valve (Model FP7)
Silicone plate Ahmed Glaucoma Valve (Model FP7)
Device: Silicone plate Ahmed Glaucoma Valve (Model FP7)
Experimental: Porous Plate Ahmed Glaucoma Valve (Model M4)
Porous Plate Ahmed Glaucoma Valve (Model M4)
Device: Porous Plate Ahmed Glaucoma Valve (Model M4)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01883856

Contacts
Contact: Peter A Netland, MD, PhD (434) 243-2852 klh7v@virginia.edu
Contact: Kristina Holbrook (434) 243-2852 klh7v@virginia.edu

Locations
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Kristina Holbrook    434-243-2852    klh7v@virginia.edu   
Principal Investigator: Peter A Netland, MD, PhD         
Sponsors and Collaborators
University of Virginia
New World Medical
Investigators
Principal Investigator: Peter A Netland, MD, PhD University of Virginia
  More Information

No publications provided

Responsible Party: University of Virginia
ClinicalTrials.gov Identifier: NCT01883856     History of Changes
Other Study ID Numbers: 16051
Study First Received: June 18, 2013
Last Updated: June 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
Refractory Glaucoma
Intractable Glaucoma
Primary Open Angle Glaucoma
Neovascular Glaucoma

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on September 18, 2014