Overview
A Prospective, Multicenter, Single-Arm, Open-Label Clinical Trial
Description
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
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