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Search / Trial NCT02036541

AqueSys XEN 45 Glaucoma Implant in Refractory Glaucoma

Launched by AQUESYS, INC. · Jan 13, 2014

Trial Information

Current as of May 11, 2025

Completed

Keywords

Glaucoma Implant Trabeculectomy Poag Primary Open Angle Glaucoma Pseudoexfoliation Glaucoma Pigmentary Glaucoma

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

  • 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

About Aquesys, Inc.

Aquesys, Inc. is an innovative biotechnology company dedicated to advancing ocular health through the development of cutting-edge therapies and medical devices. With a strong focus on addressing unmet medical needs in the field of ophthalmology, Aquesys leverages state-of-the-art research and clinical trial methodologies to deliver transformative solutions for patients suffering from various eye conditions. Committed to excellence in scientific rigor and patient safety, Aquesys collaborates with leading experts and regulatory authorities to ensure the successful translation of its research into effective treatments.

Locations

New York, New York, United States

Dallas, Texas, United States

Fort Collins, Colorado, United States

Spokane, Washington, United States

Fayetteville, Arkansas, United States

Glendale, Arizona, United States

Montebello, California, United States

Oceanside, California, United States

Palo Alto, California, United States

Overland Park, Kansas, United States

Saint Louis, Missouri, United States

San Antonio, Texas, United States

Patients applied

0 patients applied

Trial Officials

Richard A Lewis, M.D.

Study Chair

Grutzmacher, Lewis & Sierra Surgical Eye Specialists

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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