Not Yet RecruitingNot Applicable

Vizio Aqueous Microshunt Clinical Study

50 participantsStarted 2024-11

Plain-language summary

Evaluate the Safety and Efficacy of the Vizio Aqueous Microshunt for the Treatment of Refractory Glaucoma

Age range22 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. Active neovascular conditions such as active iris or corneal neovascularization, or active proliferative retinopathy in study eye.
✕. Pigmentary glaucoma in study eye.
✕. Pseudoexfoliation syndrome in study eye.
✕. Angle-closure glaucoma in study eye.
✕. Iridocorneal endothelial syndrome in study eye.
✕. Uveitic glaucoma in the study eye.
✕. Epithelial or fibrous downgrowth in the study eye.
✕. Corneal conditions in study eye inhibiting normal incisional healing (e.g. Fuch's dystrophy) or would impair visualization of implant inside anterior chamber.

Efficacy

Timeframe: 12 months

Safety

Timeframe: 12 months

NCT IDNCT06591117

SponsorOcumedex

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-05

Jon StGermain

Who can participate

Age range22 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. Active neovascular conditions such as active iris or corneal neovascularization, or active proliferative retinopathy in study eye.
✕. Pigmentary glaucoma in study eye.
✕. Pseudoexfoliation syndrome in study eye.
✕. Angle-closure glaucoma in study eye.
✕. Iridocorneal endothelial syndrome in study eye.
✕. Uveitic glaucoma in the study eye.
✕. Epithelial or fibrous downgrowth in the study eye.
✕. Corneal conditions in study eye inhibiting normal incisional healing (e.g. Fuch's dystrophy) or would impair visualization of implant inside anterior chamber.