Argus II Retinal Prosthesis System Dry AMD Feasibility Study
Research type
Research Study
Full title
Argus II Retinal Prosthesis System Dry AMD Feasibility Study
IRAS ID
157253
Contact name
Anne-Marie Ripley
Contact email
Sponsor organisation
Second Sight Medical Products Inc
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 6 months, 1 days
Research summary
The purpose of this study is to test the Argus II Retinal Prosthesis System in patients with severe age-related macular degeneration (AMD). The Argus II System has already been studied in completely blind patients with retinitis pigmentosa (RP). In RP patients, some cells of the retina are irrevocably damaged and the Argus II System has been found to restore some basic visual function. On these grounds, the device has received authorization for use on the European market (the CE certification) in 2011.
The Argus II Retinal Prosthesis System is intended to provide electrical stimulation of the retina to induce visual perception in blind individuals. It consists of a pair of glasses, a video processing unit (VPU), and an implant that is placed around and inside the eye. When the Argus II System is used, a miniature video camera on the glasses captures images in real time. The VPU converts these video images into electrical signals and sends them back to the glasses. The coil on the glasses sends the signals wirelessly to the implant. The implant then sends out small pulses of electricity to the retina. These pulses stimulate the retina, which in turn sends the signals along the optic nerve to the brain. The user perceives these pulses as patterns of light. Over time, users may learn how to interpret the visual patterns as objects and shapes.
In this study, 5 subjects with severe dry AMD who are legally blind will be implanted with the Argus II System. The study will evaluate the safety of the device and surgery, as well as functioning of the system and the extent of any restored vision. Each subject will be followed for 3 years, with their eye health and visual function tested at multiple time points.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
14/NW/1331
Date of REC Opinion
20 Oct 2014
REC opinion
Favourable Opinion