Study of the Beacon Aqueous Microshunt in Patients With Refractory Glaucoma (NCT04072016) | Clinical Trial Compass
TerminatedNot Applicable
Study of the Beacon Aqueous Microshunt in Patients With Refractory Glaucoma
Stopped: Significant risks (e.g., infection, endothelial cell loss) and high rate of channel plugging associated with product use.
United States, Canada10 participantsStarted 2020-04-29
Plain-language summary
This is a prospective, multicenter, single-arm clinical study to evaluate the safety and effectiveness of Beacon Aqueous Microshunt in patients with refractory glaucoma.
Who can participate
Age range22 Years – 85 Years
SexALL
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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: Prior failure of filtering/cilioablative procedure and/or uncontrolled IOP on maximum-tolerated medication (i.e. \>=4 classes of topical lowering medications, or fewer in the case of tolerability or efficacy issues).
✓. Primary open-angle, traumatic or neovascular glaucoma.
✓. Medicated DIOP ≥20 mmHg and ≤45 mmHg on maximum-tolerated medical therapy. Note: No washout; medications stabilized 30 days prior to assessment.
✓. Baseline BCVA of light perception or better in study eye.
✓. Visual field defects consistent with glaucomatous optic nerve damage.
✓. Glaucomatous optic nerve damage as evidenced by any of the following optic disc or retinal nerve fiber layer structural abnormalities:
Exclusion criteria
✕. No light perception vision.
✕. Conditions of active neovascular conditions, such as active iris or corneal neovascularization, or active proliferative retinopathy in study eye.