A Prospective, Multicenter Clinical Trial Designed to Evaluate the Safety and Performance of the AqueSys Microfistula Implant in Subjects With Refractory Glaucoma
Description
Detailed Description
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.
Phase
N/AInclusion and Exclusion 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
- 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
Sites
-
California
- USC Eye Institute, University of Southern California, Los Angeles, California, 90033
- Scripps Clinic, San Diego, California, 92037
-
Washington
- Spokane Eye Clinic, Spokane, Washington, 99204
-
Texas
- Texan Eye, Austin, Texas, 78731
- Glaucoma Associates of Texas, Dallas, Texas, 75231
-
Kansas
- Stiles Eyecare Excellence and Glaucoma Institute, Overland Park, Kansas, 66213
-
Arkansas
- Vold Vision, PLLC, Fayetteville, Arkansas, 72704
-
Minnesota
- Minnesota Eye Consultants, PA, Bloomington, Minnesota, 55431
-
Tennessee
- Vanderbilt Eye Institute, Nashville, Tennessee, 37232
Powered by
SC CTSI