AqueSys Microfistula Implant in Refractory Glaucoma



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:45 - Any
Updated:4/21/2016
Start Date:July 2012
End Date:April 2015

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A Prospective, Multicenter Clinical Trial Designed to Evaluate the Safety and Performance of the AqueSys Microfistula Implant in Subjects With Refractory Glaucoma

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

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.

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
We found this trial at
14
sites
Spokane, Washington 99204
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Spokane, WA
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Austin, Texas 78731
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Austin, TX
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Bethpage, NY
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Bloomington, Minnesota 55431
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Bloomington, MN
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Charlottesville, Virginia 22903
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Charlottesville, VA
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Dallas, Texas 75231
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Dallas, TX
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Fairfield, Connecticut 06824
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Fairfield, CT
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Fayetteville, Arkansas 72704
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Fayetteville, AR
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Los Angeles, CA
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Miami, FL
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Nashville, Tennessee 37232
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Nashville, TN
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New York, New York
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New York, NY
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Overland Park, KS
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San Diego, California 92037
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San Diego, CA
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