VisiPlate aqueous shunt to lower eye pressure in refractory open-angle glaucoma
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
This trial will test whether the VisiPlate implant can safely lower intraocular pressure in people whose open-angle glaucoma hasn't been controlled by medicines or prior surgeries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 165 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | Avisi Technologies Inc. Industry-sponsored |
| Locations | 12 sites (Glendale, Arizona and 11 other locations) |
| Trial ID | NCT07220876 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multicenter, single-arm, open-label study enrolling patients with refractory open-angle glaucoma to receive the VisiPlate aqueous shunt. Eligible participants must have preoperative IOP between 20 and 40 mmHg, a visual field mean deviation of -3 dB or worse, and healthy, mobile conjunctiva with Shaffer angle grade ≥2 in the target quadrant. The implant procedure will be performed at three U.S. sites and participants will be followed for IOP changes and safety outcomes. Primary outcomes include intraocular pressure reduction and device-related adverse events, along with the need for additional glaucoma procedures.
Who should consider this trial
Good fit: Ideal candidates are adults with open-angle (including pseudoexfoliative or pigmentary) glaucoma with IOP 20–40 mmHg despite prior treatments, a visual field mean deviation ≤ -3 dB, and suitable conjunctiva and angle anatomy in the target quadrant.
Not a fit: Patients with angle-closure, neovascular or other secondary glaucomas, prior glaucoma shunts in the target quadrant, recent ocular inflammation or infection, significant corneal disease, or unrelated retinal or optic nerve disorders are unlikely to benefit.
Why it matters
Potential benefit: If successful, the device could provide sustained lowering of intraocular pressure and reduce reliance on medications or more invasive glaucoma surgeries.
How similar studies have performed: Other minimally invasive and aqueous shunt devices have shown intraocular pressure lowering in prior studies, but VisiPlate is a newer design with limited published human data so far.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Glendale, Arizona and 11 other locations
- Arizona Advanced Eye Research — Glendale, Arizona, United States (Recruiting)
- Sacramento Eye Consultants — Sacramento, California, United States (Recruiting)
- ICON Eye Care — Grand Junction, Colorado, United States (Recruiting)
- Mile High Eye Institute — Sheridan, Colorado, United States (Withdrawn)
- Cleveland Clinic- Cole Eye Institute — Cleveland, Ohio, United States (Not_yet_recruiting)
- Scheie Eye Institute — Philadelphia, Pennsylvania, United States (Not_yet_recruiting)
- Wills Eye Hospital — Philadelphia, Pennsylvania, United States (Not_yet_recruiting)
- Glaucoma Associates of Texas — Dallas, Texas, United States (Recruiting)
- University of Texas Southwestern — Dallas, Texas, United States (Not_yet_recruiting)
- The Eye Centers of Racine & Kenosha — Kenosha, Wisconsin, United States (Recruiting)
- Lynette Venter — Bloemfontein, South Africa (Not_yet_recruiting)
- Pretoria Eye Institute — Pretoria, South Africa (Not_yet_recruiting)
Study contacts
- Study coordinator: Katherine Lee
- Email: kati@avisitech.com
- Phone: 12816100251
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.