AqueSys XEN 45 Glaucoma Implant in Refractory Glaucoma

Completed · Not applicable

Conditions studied: Glaucoma, Glaucoma, Open Angle

In brief

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

Key facts

Study ID

NCT02036541

Run by

AqueSys, Inc.

People needed

65

Starts

2013-01-01

Expected to finish

2016-08-01

Last updated by the study team

2017-06-01

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• George R. Reiss, MD PC — Glendale, Arizona, United States
• Vold Vision — Fayetteville, Arkansas, United States
• Montebello Eye Center — Montebello, California, United States
• San Diego Eye Care Center — Oceanside, California, United States
• Palo Alto Eye Group — Palo Alto, California, United States
• Eye Center of Northern Colorado — Fort Collins, Colorado, United States
• Stiles Eyecare Excellence & Glaucoma Institute — Overland Park, Kansas, United States
• Washington University in St. Louis, Department of Ophthalmology — St Louis, Missouri, United States
• New York Eye and Ear Infirmary — New York, New York, United States
• Glaucoma Associates of Texas — Dallas, Texas, United States
• R and R Eye Research, LLC — San Antonio, Texas, United States
• Spokane Eye Clinic — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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