Trials / Completed
CompletedNCT03469297
Early Feasibility Study of the Brown Glaucoma Implant in Patients With Severe Visual Impairment or No Light Perceived
Early Feasibility Study of the Brown Glaucoma Implant in Patients With No Light Perceived
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 8 (actual)
- Sponsor
- MicroOptx · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, non-randomized, single-arm early feasibility study to assess the safety and feasibility of lowering intraocular pressure with the Brown Glaucoma Implant. A total of up to 10 subjects will be enrolled at three centers. Subjects will be followed for 24 months, with the primary assessments completed 6 months after implant.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Brown Glaucoma Implant | The Brown Glaucoma Implant (BGI) 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
- 2018-05-01
- Primary completion
- 2020-03-26
- Completion
- 2021-09-20
- First posted
- 2018-03-19
- Last updated
- 2022-12-28
- Results posted
- 2022-12-05
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03469297. Inclusion in this directory is not an endorsement.