NCT07220876

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started Nov 2025

Typical duration for not_applicable

Geographic Reach
2 countries

12 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress26%
Nov 2025Oct 2027

First Submitted

Initial submission to the registry

October 22, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

November 7, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

December 15, 2025

Status Verified

October 1, 2025

Enrollment Period

1.9 years

First QC Date

October 22, 2025

Last Update Submit

December 8, 2025

Conditions

Open Angle Glaucoma (OAG)

Keywords

Glaucoma

Outcome Measures

Primary Outcomes (1)

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

    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%.

    12 Months

Secondary Outcomes (1)

  • Percentage change in mean diurnal IOP

    12 months

Study Arms (1)

Treatment Arm

EXPERIMENTAL
Device: VisiPlate Glaucoma Implant

Interventions

VisiPlate Glaucoma ImplantDEVICE

Implant (micro-shunt) for glaucoma patients

Treatment Arm

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Arizona Advanced Eye Research

Glendale, Arizona, 85306, United States

RECRUITING

Sacramento Eye Consultants

Sacramento, California, 95815, United States

RECRUITING

ICON Eye Care

Grand Junction, Colorado, 81501, United States

RECRUITING

Mile High Eye Institute

Sheridan, Colorado, 80226, United States

WITHDRAWN

Cleveland Clinic- Cole Eye Institute

Cleveland, Ohio, 44195, United States

NOT YET RECRUITING

Scheie Eye Institute

Philadelphia, Pennsylvania, 19104, United States

NOT YET RECRUITING

Wills Eye Hospital

Philadelphia, Pennsylvania, 19107, United States

NOT YET RECRUITING

Glaucoma Associates of Texas

Dallas, Texas, 75231, United States

RECRUITING

University of Texas Southwestern

Dallas, Texas, 75390, United States

NOT YET RECRUITING

The Eye Centers of Racine & Kenosha

Kenosha, Wisconsin, 53142, United States

RECRUITING

Lynette Venter

Bloemfontein, 9301, South Africa

NOT YET RECRUITING

Pretoria Eye Institute

Pretoria, 0007, South Africa

NOT YET RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-AngleGlaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Central Study Contacts

Katherine Lee

CONTACT

12816100251kati@avisitech.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2025

First Posted

October 24, 2025

Study Start

November 7, 2025

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

December 15, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

ZA(2)US(10)