AqueSys XEN 45 Glaucoma Implant in Refractory Glaucoma



Status:Recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:45 - Any
Updated:2/8/2015
Start Date:January 2013
End Date:June 2016
Contact:Rupali N Jobanputra
Email:rjobanputra@aquesys.com
Phone:949-450-0250

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A Prospective, Multicenter Clinical Trial Designed to Evaluate the Safety and Performance of the AqueSys XEN 45 Glaucoma Implant in Subjects With Refractory Glaucoma

To establish the safety and performance of the AqueSys XEN 45 Glaucoma 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 XEN 45 Glaucoma Implant in refractory glaucoma
patients.

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
12
sites
New York, New York
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Dallas, Texas 75231
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Dallas, TX
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Fayetteville, Arkansas 72704
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Fayetteville, AR
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Fort Collins, Colorado 80525
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Fort Collins, CO
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Glendale, Arizona 85306
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Glendale, AZ
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Montebello, California 90640
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Montebello, CA
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Oceanside, California 92056
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Oceanside, CA
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Overland Park, KS
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Palo Alto, California 94306
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Palo Alto, CA
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San Antonio, Texas 78229
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San Antonio, TX
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Spokane, Washington 99204
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Spokane, WA
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St. Louis, MO
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