Safety and Effectiveness of the VisiPlate Aqueous Shunt in Patients With 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

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.

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