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VisiPlate Aqueous Shunt for Refractory Open-Angle Glaucoma

This study is looking at the safety and effectiveness of the VisiPlate Glaucoma Implant, a small device (micro-shunt) designed to help lower eye pressure in people with open-angle glaucoma (OAG). This is for individuals whose medical and surgical treatments haven't worked well. You might be able to join if you have open-angle, pseudoexfoliative, or pigmentary glaucoma, with eye pressure between 20mmHg and 40mmHg, and a certain level of vision loss. The study aims to see if at least 20% of participants have a significant drop in their eye pressure after 12 months. The current status of this study is unclear, and it plans to enroll 165 people.

Study design
This is a prospective, multicenter, single-arm, open-label clinical trial, meaning all participants will receive the VisiPlate Glaucoma Implant, and both you and the study team will know what treatment you are receiving. It plans to enroll 165 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary goal is measured at 12 months, suggesting follow-up for at least that long after receiving the implant.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07220876

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

Recruiting
NAAges 45+InterventionalTreatment
Avisi Technologies Inc.
~165 participants
Updated 2025-12-15 on ClinicalTrials.gov
What's tested:VisiPlate Glaucoma Implant

At a glance

Recruiting sites
5 of 12 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of subjects (eyes) achieving a ≥ 20% reduction in mean diurnal intraocular pressure
Measured over 12 Months

Conditions

Open Angle Glaucoma (OAG)

Explore related trials

Exfoliation SyndromeOpen Angle Glaucoma

Where it's being run

12 sites across 8 states
Colorado2
Pennsylvania2
Texas2
South Africa2
Arizona1
California1
Ohio1
Wisconsin1

Who to contact

Katherine Lee
[email protected]
12816100251
Email the study team

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Do you actually qualify for this trial?

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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

What this trial measures

  • Proportion of subjects (eyes) achieving a ≥ 20% reduction in mean diurnal intraocular pressure12 Months

    The eye is filled with a special fluid. The intraocular pressure is the amount of fluid that builds up in the eye. The primary outcome is the number of people whose eye pressure went down by at least 20%.