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

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/A

Inclusion 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
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