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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-07

Study Completion Date

2027-10-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Open Angle Glaucoma (OAG)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Arm

Group Type EXPERIMENTAL

VisiPlate Glaucoma Implant

Intervention Type DEVICE

Implant (micro-shunt) for glaucoma patients

Interventions

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VisiPlate Glaucoma Implant

Implant (micro-shunt) for glaucoma patients

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Arizona Advanced Eye Research

Glendale, Arizona, United States

Site Status RECRUITING

Sacramento Eye Consultants

Sacramento, California, United States

Site Status RECRUITING

ICON Eye Care

Grand Junction, Colorado, United States

Site Status RECRUITING

Mile High Eye Institute

Sheridan, Colorado, United States

Site Status WITHDRAWN