Trials / Active Not Recruiting
Active Not RecruitingNCT03392324
PRIMA US-Feasibility Study in Atrophic Dry AMD
Feasibility Study of Compensation for Blindness With the PRIMA System in Patients With Atrophic Dry Age Related Macular Degeneration
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- Science Corporation · Industry
- Sex
- All
- Age
- 60 Years
- Healthy volunteers
- Not accepted
Summary
In this early feasibility trial the safety and performance of the new retinal prothesis PRIMA is tested in five subjects suffering from atrophic dry age related macular degeneration.
Detailed description
PRIMA is a new photovoltaic sub-retinal wireless prosthesis for partial restoration of visual perception in patients with vision loss from atrophic dry Age-related Macular Degeneration. The implantable part of the device is placed under the retina. A mini camera mounted on a pair of glasses captures the visual scene in the environment. The visual scene is processed and simplified by the pocket computer connected to the glasses in order to extract useful information from the images. The simplified images are then sent back to the glasses where a miniaturized projector then projects the processed images wirelessly via pulses of near infrared light on the PRIMA implant at the back of the eye under the retina. The photovoltaic cells convert this optical information into electrical stimulation to excite the nerve cells of the retina and induce visual perception. In this early feasibility study five human subjects suffering from atrophic dry age related macular degeneration will receive the implant. The performance and the safety of the device will be monitored for up to 36 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | PRIMA | Implantation of PRIMA device |
Timeline
- Start date
- 2018-04-26
- Primary completion
- 2026-09-01
- Completion
- 2026-09-01
- First posted
- 2018-01-05
- Last updated
- 2026-04-02
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03392324. Inclusion in this directory is not an endorsement.