Safety and Effectiveness of the VisiPlate Aqueous Shunt in Patients With Refractory Open-Angle Glaucoma
Recruiting now · Not applicable
Conditions studied: Open Angle Glaucoma (OAG)
In brief
A Prospective, Multicenter, Single-Arm, Open-Label Clinical Trial
Key facts
- Study ID
- NCT07220876
- Run by
- Avisi Technologies Inc.
- People needed
- 165
- Starts
- 2025-11-07
- Expected to finish
- 2027-10-01
- Last updated by the study team
- 2025-12-15
Who can join
Age: 45 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Glaucoma Associates of Texas — Dallas, Texas, United States (enrolling)
- Sacramento Eye Consultants — Sacramento, California, United States (enrolling)
- The Eye Centers of Racine & Kenosha — Kenosha, Wisconsin, United States (enrolling)
- ICON Eye Care — Grand Junction, Colorado, United States (enrolling)
- Arizona Advanced Eye Research — Glendale, Arizona, United States (enrolling)
- University of Texas Southwestern — Dallas, Texas, United States
- Lynette Venter — Bloemfontein, South Africa
- Pretoria Eye Institute — Pretoria, South Africa
- 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
Full record on ClinicalTrials.gov
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