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.
Age
45–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | Safety and Effectiveness of the VisiPlate Aqueous Shunt in Patients With Refractory Open-Angle Glaucoma
