AqueSys Microfistula Implant in Refractory Glaucoma

Completed · Phase 3

Conditions studied: Glaucoma, Glaucoma, Open-Angle

In brief

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

Key facts

Study ID

NCT01640756

Run by

AqueSys, Inc.

People needed

60

Starts

2012-07-01

Expected to finish

2015-04-01

Last updated by the study team

2016-02-08

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

• Vold Vision, PLLC — Fayetteville, Arkansas, United States
• USC Eye Institute, University of Southern California — Los Angeles, California, United States
• Scripps Clinic — San Diego, California, United States
• Ophthalmic Consultants of Connecticut — Fairfield, Connecticut, United States
• Bascom Palmer Eye Institute, University of Miami — Miami, Florida, United States
• Stiles Eyecare Excellence and Glaucoma Institute — Overland Park, Kansas, United States
• Minnesota Eye Consultants, PA — Bloomington, Minnesota, United States
• Eye Care Associates & Glaucoma Consultants of Long Island — Bethpage, New York, United States
• New York Eye and Ear Infirmary — New York, New York, United States
• Vanderbilt Eye Institute — Nashville, Tennessee, United States
• Texan Eye — Austin, Texas, United States
• Glaucoma Associates of Texas — Dallas, Texas, United States
• UVA Eye Clinic, University of Virginia — Charlottesville, Virginia, United States
• Spokane Eye Clinic — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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