Safety and Effectiveness of the VisiPlate Aqueous Shunt in Patients With Refractory Open-Angle Glaucoma

Avisi Technologies Inc.

Status: Enrolling

Conditions: Open Angle Glaucoma (OAG)

Treatments: Device: VisiPlate Glaucoma Implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT07220876

CP0005

Details and patient eligibility

About

A Prospective, Multicenter, Single-Arm, Open-Label Clinical Trial

Full 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.

Enrollment: 165 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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165 participants in 1 patient group

Treatment Arm

Experimental group

Treatment:

Device: VisiPlate Glaucoma Implant