Safety and Performance of IRIS V2 System
Research type
Research Study
Full title
Compensation for blindness with the Intelligent Retinal Implant System (IRIS V2) in patients with retinal dystrophy
IRAS ID
198526
Contact name
Karine Chevrie
Contact email
Sponsor organisation
Pixium Vision
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 0 months, 1 days
Research summary
An open-label clinical trial to evaluate the safety and performance of a newly developed Intelligent Retinal Implant System (IRIS V2) in patients with retinal dystrophy. IRIS V2 is designed to restore some limited visual perception in persons who have lost their sight due to the degeneration of photoreceptor cells.
The IRIS V2 consists of 3 main components
1) A visual interface (a camera with data transmitters mounted on spectacles)
2) A pocket processor (processes data to generate retinal stimulation commands)
3) A retinal implant (receives commands from the visual interface to stimulate the retina)Up to 10 patients will be implanted. Depending on the number of screening failures, up to 20 patients will be enrolled across the EU with retinitis pigmentosa, cone rod dystrophy or choroideremia. Participants will be followed for up to 3 years post implant.
REC name
London - Dulwich Research Ethics Committee
REC reference
16/LO/0409
Date of REC Opinion
11 Apr 2016
REC opinion
Further Information Favourable Opinion