AqueSys Microfistula Implant in Refractory Glaucoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01640756
Recruitment Status : Completed
First Posted : July 16, 2012
Last Update Posted : February 8, 2016
Information provided by (Responsible Party):
AqueSys, Inc.

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

Condition or disease Intervention/treatment Phase
Glaucoma Glaucoma, Open-Angle Device: AqueSys Microfistula Implant Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2012
Actual Primary Completion Date : November 2014
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: AqueSys Microfistula Implant Device: AqueSys Microfistula Implant
Placement of the AqueSys Microfistula Implant in the study eye

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Mean change in IOP from baseline [ Time Frame: 12 Months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01640756

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.
Study Chair: Richard A Lewis, M.D. Grutzmacher and Lewis Surgical Eye Specialists

Responsible Party: AqueSys, Inc. Identifier: NCT01640756     History of Changes
Other Study ID Numbers: P11-001
First Posted: July 16, 2012    Key Record Dates
Last Update Posted: February 8, 2016
Last Verified: January 2016

Keywords provided by AqueSys, Inc.:
Glaucoma Implant

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