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 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: 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:

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

Effectiveness via Intraocular Pressure Reduction

Timeframe: 12 Months

Safety via Serious and Adverse Event Reporting

Timeframe: 12 Months

Trial details

NCT IDNCT04072016

SponsorMicroOptx

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-05-16

View on ClinicalTrials.gov More Glaucoma trials

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: 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:

Study of the Beacon Aqueous Microshunt in Patients With Refractory Glaucoma

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Study of the Beacon Aqueous Microshunt in Patients With Refractory Glaucoma

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria