Safety and Effectiveness of the VisiPlate Aqueous Shunt in Patients With Refractory Open-Angle Glaucoma
Recruiting · NCT07220876 · Interventional (participants receive a specific treatment) · Lead sponsor: Avisi Technologies Inc.
View the official record on ClinicalTrials.gov →Interventions studied
VisiPlate Glaucoma Implant
What this trial is about
A Prospective, Multicenter, Single-Arm, Open-Label Clinical Trial
Who can take part
Age range
45 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
12 locations listed across 7 US states.
- Arizona Advanced Eye Research - Glendale, Arizona, United States
- Sacramento Eye Consultants - Sacramento, California, United States
- ICON Eye Care - Grand Junction, Colorado, United States
- Mile High Eye Institute - Sheridan, Colorado, United States
- Cleveland Clinic- Cole Eye Institute - Cleveland, Ohio, United States
- Scheie Eye Institute - Philadelphia, Pennsylvania, United States
- Wills Eye Hospital - Philadelphia, Pennsylvania, United States
- Glaucoma Associates of Texas - Dallas, Texas, United States
- University of Texas Southwestern - Dallas, Texas, United States
- The Eye Centers of Racine & Kenosha - Kenosha, Wisconsin, United States
- Lynette Venter - Bloemfontein, South Africa
- Pretoria Eye Institute - Pretoria, South Africa