TrialPath
← Back to searchRecruiting

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

NCT07220876 · Avisi Technologies Inc.
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official 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
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.
Eligibility criteria
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 target: 165 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-11-07
Estimated completion: 2027-10
Last updated: 2025-12-15
Interventions
Device: VisiPlate Glaucoma Implant
Primary outcomes
  • Proportion of subjects (eyes) achieving a ≥ 20% reduction in mean diurnal intraocular pressure (12 Months)
Sponsor
Avisi Technologies Inc. · industry
Contacts & investigators
ContactKatherine Lee · contact · kati@avisitech.com · 12816100251
All locations (12)
Arizona Advanced Eye ResearchRecruiting
Glendale, Arizona, United States
Sacramento Eye ConsultantsRecruiting
Sacramento, California, United States
ICON Eye CareRecruiting
Grand Junction, Colorado, United States
Mile High Eye InstituteWithdrawn
Sheridan, Colorado, United States
Cleveland Clinic- Cole Eye InstituteNot Yet Recruiting
Cleveland, Ohio, United States
Scheie Eye InstituteNot Yet Recruiting
Philadelphia, Pennsylvania, United States
Wills Eye HospitalNot Yet Recruiting
Philadelphia, Pennsylvania, United States
Glaucoma Associates of TexasRecruiting
Dallas, Texas, United States
University of Texas SouthwesternNot Yet Recruiting
Dallas, Texas, United States
The Eye Centers of Racine & KenoshaRecruiting
Kenosha, Wisconsin, United States
Lynette VenterNot Yet Recruiting
Bloemfontein, South Africa
Pretoria Eye InstituteNot Yet Recruiting
Pretoria, South Africa
Safety and Effectiveness of the VisiPlate Aqueous Shunt in Patients With Refractory Open-Angle Glaucoma · TrialPath