Recruiting

Observational Study

Sponsor:

Avisi Technologies Inc.

Code:

NCT07220876

Conditions

Open Angle Glaucoma (OAG)

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

Interventions

VisiPlate Glaucoma Implant

Study Details

Brief summary:

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

Conditions

Open Angle Glaucoma (OAG)

Study ID

NCT07220876

Start date

Nov 7, 2025

Status verified date

Oct, 2025

Completion date

Oct, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

165 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment Arm

Interventions

VisiPlate Glaucoma Implant

Implant (micro-shunt) for glaucoma patients

Primary outcome measure

  • Proportion of subjects (eyes) achieving a ≥ 20% reduction in mean diurnal intraocular pressure [ Time Frame: 12 Months ]

Central Contacts and Locations

Central contacts

Katherine Lee

12816100251kati@avisitech.com

Locations

Arizona Advanced Eye Research

Recruiting

Glendale, Arizona, United States, 85306

Sacramento Eye Consultants

Recruiting

Sacramento, California, United States, 95815

ICON Eye Care

Recruiting

Grand Junction, Colorado, United States, 81501

Glaucoma Associates of Texas

Recruiting

Dallas, Texas, United States, 75231

The Eye Centers of Racine & Kenosha

Recruiting

Kenosha, Wisconsin, United States, 53142

More Information

Sponsor

Avisi Technologies Inc.

Last update posted

Dec 15, 2025

Last verified

Oct, 2025

Keywords

  • Glaucoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Avisi Technologies Inc. on 2025-12-15.