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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Trial Summary
Trial Overview
Inclusion Criteria

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 Eye Clinic
Spokane, Washington 99204
1201
mi
from
Spokane, WA
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Texan Eye
Austin, Texas 78731
511
mi
from
Austin, TX
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Eye Care Associates & Glaucoma Consultants of Long Island
Bethpage, New York 11714
1314
mi
from
Bethpage, NY
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Minnesota Eye Consultants
Bloomington, Minnesota 55431
542
mi
from
Bloomington, MN
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UVA Eye Clinic, University of Virginia
Charlottesville, Virginia 22903
1053
mi
from
Charlottesville, VA
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Glaucoma Associates of Texas
Dallas, Texas 75231
342
mi
from
Dallas, TX
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Ophthalmic Consultants of Connecticut
Fairfield, Connecticut 06824
1328
mi
from
Fairfield, CT
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Vold Vision, PLLC
Fayetteville, Arkansas 72704
233
mi
from
Fayetteville, AR
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USC Eye Institute, University of Southern California
Los Angeles, California 90033
1166
mi
from
Los Angeles, CA
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Bascom Palmer Eye Institute, University of Miami
Miami, Florida 33136
1320
mi
from
Miami, FL
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Vanderbilt Eye Institute
Nashville, Tennessee 37232
618
mi
from
Nashville, TN
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New York Eye & Ear Infirmary
New York, New York
1286
mi
from
New York, NY
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Stiles Eyecare Excellence and Glaucoma Institute
Overland Park, Kansas 66213
190
mi
from
Overland Park, KS
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Scripps Clinic
San Diego, California 92037
1142
mi
from
San Diego, CA
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