Vizio Aqueous Microshunt Clinical Study

Inclusion criteria

• . Age 22-85 years.
• . Refractory glaucoma describes eyes uncontrolled by medical therapy and diagnosed with glaucoma which meet at least one of the following criteria: 1) Failed one or more incisional intraocular glaucoma surgeries (e.g., glaucoma filtering surgery or tube shunt); 2) Failed one or more cilioablative procedures (e.g., cryotherapy, cyclodiode therapy); 3) Have any other condition (e.g., conjunctival scarring, uveitis) in which a conventional incisional glaucoma surgery like trabeculectomy would be more likely to fail than for an eye with uncomplicated primary open angle glaucoma.
• . Primary open-angle or traumatic glaucoma.
• . Medicated DIOP ≥25 mmHg and ≤45 mmHg on maximum-tolerated medical therapy that is stable for at least 30 days.
• . Best-corrected baseline visual acuity of light perception or better in study eye.
• . Glaucomatous optic nerve damage as evidenced by any of the following optic disc or retinal nerve fiber layer structural abnormalities:
• . Visual field mean deviation (MD) by Humphrey Visual Field: Visual field defects consistent with glaucomatous optic nerve damage and mean deviation worse than -3 dB in the study eye; and at least one of the following two findings:
• . At least two contiguous clock hours of intact conjunctiva near the limbus between clock hours of 10:00 and 02:00 in the study eye.

Exclusion criteria