Status:
RECRUITING
Safety and Effectiveness of the VisiPlate Aqueous Shunt in Patients With Refractory Open-Angle Glaucoma
Lead Sponsor:
Avisi Technologies Inc.
Conditions:
Open Angle Glaucoma (OAG)
Eligibility:
All Genders
45+ years
Phase:
NA
Brief Summary
A Prospective, Multicenter, Single-Arm, Open-Label Clinical Trial
Detailed Description
To evaluate the safety and effectiveness of VisiPlate Aqueous Shunt to lower intraocular pressure (IOP) in subjects with open-angle glaucoma for whom medical and surgical treatments have failed.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT07220876
Start Date
November 7 2025
End Date
October 1 2027
Last Update
December 15 2025
Active Locations (12)
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1
Arizona Advanced Eye Research
Glendale, Arizona, United States, 85306
2
Sacramento Eye Consultants
Sacramento, California, United States, 95815
3
ICON Eye Care
Grand Junction, Colorado, United States, 81501
4
Mile High Eye Institute
Sheridan, Colorado, United States, 80226