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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Trial Summary
Trial Overview
Inclusion Criteria

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 Eye & Ear Infirmary
New York, New York
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New York, NY
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Glaucoma Associates of Texas
Dallas, Texas 75231
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from
Dallas, TX
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Vold Vision, PLLC
Fayetteville, Arkansas 72704
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from
Fayetteville, AR
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Eye Center of Northern Colorado
Fort Collins, Colorado 80525
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from
Fort Collins, CO
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George R. Reiss, MD, PC
Glendale, Arizona 85306
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mi
from
Glendale, AZ
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Montebello Eye Center
Montebello, California 90640
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from
Montebello, CA
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San Diego Eye Care Center
Oceanside, California 92056
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mi
from
Oceanside, CA
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Stiles Eyecare Excellence and Glaucoma Institute
Overland Park, Kansas 66213
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mi
from
Overland Park, KS
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Palo Alto Eye Group
Palo Alto, California 94306
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mi
from
Palo Alto, CA
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R and R Eye Research, LLC
San Antonio, Texas 78229
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mi
from
San Antonio, TX
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Spokane Eye Clinic
Spokane, Washington 99204
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mi
from
Spokane, WA
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Washington University in St. Louis, Department of Ophthalmology
St. Louis, Missouri 63110
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mi
from
St. Louis, MO
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