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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03392324
Study type Interventional
Source Pixium Vision SA
Contact
Status Active, not recruiting
Phase N/A
Start date April 26, 2018
Completion date December 2025

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