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NCT Number: NCT07220876

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

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

Recruiting

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Key information

Conditions

Open Angle Glaucoma (OAG) Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lynette Venter, Bloemfontein, South Africa

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VisiPlate Glaucoma Implant

Device

Implant (micro-shunt) for glaucoma patients

Primary outcomes

  1. Proportion of subjects (eyes) achieving a ≥ 20% reduction in mean diurnal intraocular pressure

    Time frame: 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 outcomes

  1. Percentage change in mean diurnal IOP

    Time frame: 12 months

    How much the average eye pressure during the day went up or down, shown as a percent.

Study contacts

Contact information is provided by the study sponsor or research team.

Katherine Lee

CONTACT

[email protected]

12816100251

Sponsors and collaborators

Lead sponsor

Avisi Technologies Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 24, 2025
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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