The Vizio Clinical Study (NCT06591117) | Clinical Trial Compass
RecruitingNot Applicable
The Vizio Clinical Study
El Salvador50 participantsStarted 2026-03-21
Plain-language summary
Evaluate the Safety and Efficacy of the Vizio Aqueous Microshunt for the Treatment of Refractory Glaucoma
Who can participate
Age range
22 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 22-85 years
. Refractory glaucoma describes eyes diagnosed with glaucoma specific to one of the following:
. 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:
Exclusion criteria
. Active neovascular conditions such as active iris or corneal neovascularization, or active proliferative retinopathy in study eye.
. Pigmentary glaucoma in study eye.
. Angle-closure glaucoma in study eye.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Efficiency of IOP reduction as measured through Applanation Tonometry
Timeframe: 12 months
2
Safety of the Vizio device and procedure as monitored through adverse event reporting. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
. Epithelial or fibrous downgrowth in the study eye.
. Corneal conditions in study eye inhibiting normal incisional healing (e.g. Fuch's dystrophy) or impair visualization of implant inside the anterior chamber.