RecruitingNot ApplicableNCT07220876
Safety and Effectiveness of the VisiPlate Aqueous Shunt in Patients With Refractory Open-Angle Glaucoma
A Prospective, Multicenter, Single-Arm, Open-Label Clinical Trial of the Safety and Effectiveness of the VisiPlate Aqueous Shunt in Patients With Refractory Open-Angle Glaucoma
Sponsor
Avisi Technologies Inc.
Enrollment
165 participants
Start Date
Nov 7, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
A Prospective, Multicenter, Single-Arm, Open-Label Clinical Trial
Eligibility
Min Age: 45 Years
Inclusion Criteria5
- Open angle, pseudoexfoliative or pigmentary glaucoma
- IOP at preoperative visit of ≥ 20mmHg and ≤ 40mmHg
- Visual field mean deviation score of -3dB or worse
- Area of healthy, free and mobile conjunctiva in the target quadrant
- Shaffer angle grade ≥ 2 in the target quadrant
Exclusion Criteria7
- Angle closure glaucoma
- Congenital, neovascular or other secondary glaucomas
- Previous intraocular surgery, with the exception of uncomplicated cataract surgery
- Previous glaucoma shunt/valve in the target quadrant
- Clinically significant inflammation or infection in the study eye within 30 days prior to the operative visit
- History of corneal surgery, corneal opacities or corneal disease
- Retinal or optic nerve disorders, either degenerative or evolutive, that are not associated with the existing glaucoma condition
Interventions
DEVICEVisiPlate Glaucoma Implant
Implant (micro-shunt) for glaucoma patients
Locations(12)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07220876
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