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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07220876

Enrollment

165

Registered

2025-10-24

Start date

2025-11-07

Completion date

2027-10-31

Last updated

2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open Angle Glaucoma (OAG)

Keywords

Glaucoma

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.

Interventions

DEVICEVisiPlate Glaucoma Implant

Implant (micro-shunt) for glaucoma patients

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

45 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Proportion of subjects (eyes) achieving a ≥ 20% reduction in mean diurnal intraocular pressure	12 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%.

Secondary

Measure	Time frame	Description
Percentage change in mean diurnal IOP	12 months	How much the average eye pressure during the day went up or down, shown as a percent.

Countries

South Africa, United States

Contacts

Primary ContactKatherine Lee

kati@avisitech.com12816100251

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026