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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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
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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