Trials / Terminated
TerminatedNCT03634319
Early Evaluation of the Beacon Aqueous Microshunt in Patients Refractory to Drug Therapy in the European Union
Early Evaluation of the Brown Glaucoma Implant in Patients Refractory to Drug Therapy in the European Union
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- MicroOptx · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
Summary
This is prospective, non-randomized, single-arm study to assess the safety and effectiveness of lowering intraocular pressure with the Beacon Aqueous Microshunt. A total of 65 subjects will be enrolled at five centers. The primary endpoint will be assessed at 12 month follow-up.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Beacon Aqueous Microshunt | The Beacon Aqueous Microshunt is an implantable device designed to lower intraocular pressure (IOP) in glaucoma patients by shunting aqueous humor from the anterior chamber of the eye to the surface of the eye. Because there are no physiologic sources of outflow resistance, the device can be engineered to target an IOP that is low enough to halt the progression to blindness in a patient suffering from glaucoma. |
Timeline
- Start date
- 2018-06-01
- Primary completion
- 2021-11-11
- Completion
- 2023-01-08
- First posted
- 2018-08-16
- Last updated
- 2023-01-10
Locations
2 sites across 1 country: Germany
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03634319. Inclusion in this directory is not an endorsement.