AqueSys Microfistula Implant in Refractory Glaucoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AqueSys, Inc.
ClinicalTrials.gov Identifier:
NCT01640756
First received: July 12, 2012
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

To establish the safety and performance of the AqueSys Microfistula Implant in eyes with refractory glaucoma.


Condition Intervention Phase
Glaucoma
Glaucoma, Open-Angle
Device: AqueSys Microfistula Implant
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter Clinical Trial Designed to Evaluate the Safety and Performance of the AqueSys Microfistula Implant in Subjects With Refractory Glaucoma

Resource links provided by NLM:


Further study details as provided by AqueSys, Inc.:

Primary Outcome Measures:
  • Proportion of subjects achieving a 20% or greater reduction in IOP from baseline on the same or less number of medications [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change in IOP from baseline [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: July 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AqueSys Microfistula Implant Device: AqueSys Microfistula Implant
Placement of the AqueSys Microfistula Implant in the study eye

Detailed Description:

A prospective, multi-center, single arm, open-label clinical trial to evaluate the safety and IOP lowering performance of the AqueSys Microfistula Implant in refractory glaucoma patients who have previously failed a glaucoma procedure and who are not well-controlled on IOP lowering medications.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Refractory Glaucoma
  • Maximally-tolerated medicated IOP at two preoperative visits of ≥20 mmHg and ≤35 mmHg
  • Visual field mean deviation score of -3 dB or worse
  • Shaffer Angle Grade ≥ 3
  • Area of free, healthy and mobile conjunctiva in the targeted quadrant

Exclusion Criteria:

  • Active Neovascular Glaucoma
  • Previous glaucoma shunt/valve in the targeted quadrant
  • History of corneal surgery, opacities or disease/pathology
  • Anticipated need for ocular surgery
  • Non-study eye with BCVA of 20/200 or worse
  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: NCT01640756

Locations
United States, Arkansas
Vold Vision, PLLC
Fayetteville, Arkansas, United States, 72704
United States, California
USC Eye Institute, University of Southern California
Los Angeles, California, United States, 90033
Scripps Clinic
San Diego, California, United States, 92037
United States, Connecticut
Ophthalmic Consultants of Connecticut
Fairfield, Connecticut, United States, 06824
United States, Florida
Bascom Palmer Eye Institute, University of Miami
Miami, Florida, United States, 33136
United States, Kansas
Stiles Eyecare Excellence and Glaucoma Institute
Overland Park, Kansas, United States, 66213
United States, Minnesota
Minnesota Eye Consultants, PA
Bloomington, Minnesota, United States, 55431
United States, New York
Eye Care Associates & Glaucoma Consultants of Long Island
Bethpage, New York, United States, 11714
New York Eye and Ear Infirmary
New York, New York, United States, 10003
United States, Tennessee
Vanderbilt Eye Institute
Nashville, Tennessee, United States, 37232
United States, Texas
Texan Eye
Austin, Texas, United States, 78731
Glaucoma Associates of Texas
Dallas, Texas, United States, 75231
United States, Virginia
UVA Eye Clinic, University of Virginia
Charlottesville, Virginia, United States, 22903
United States, Washington
Spokane Eye Clinic
Spokane, Washington, United States, 99204
Sponsors and Collaborators
AqueSys, Inc.
Investigators
Study Chair: Richard A Lewis, M.D. Grutzmacher and Lewis Surgical Eye Specialists
  More Information

No publications provided

Responsible Party: AqueSys, Inc.
ClinicalTrials.gov Identifier: NCT01640756     History of Changes
Other Study ID Numbers: P11-001
Study First Received: July 12, 2012
Last Updated: November 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by AqueSys, Inc.:
Glaucoma Implant
Trabeculectomy
POAG

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on October 16, 2014