Safety and Effectiveness of the VisiPlate Aqueous Shunt in Patients With Refractory Open-Angle Glaucoma
Sponsored by Avisi Technologies Inc.
About this study
A Prospective, Multicenter, Single-Arm, Open-Label Clinical Trial
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.
Where this study is enrolling (2)
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Arizona Advanced Eye Research
Glendale, Arizona
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Wills Eye Hospital
Philadelphia, Pennsylvania
Who can participate
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
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Trial data sourced from ClinicalTrials.gov.