The study objective is to demonstrate safety of the NR 600 System, and to evaluate the performance of the device in restoring visual activity of daily living in subjects with retinal degenerative diseases and severe visual impairment
The NR600 is a retinal prosthetic system intended to provide electrical stimulation to the retina to induce visual perception in patients with severe to profound vision loss due to degenerative retinal disease. The system is consisting of an autonomous epiretinal implant with penetrating electrodes, Glasses and a Clinician Station. The implant is Infrared (IR) powered and is designed to convert visual input into well-defined electrical stimulation patterns suited to elicit neuronal retina activity. All study subjects will be implanted with the device in one eye and will be followed for 18-months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Retinal surgery and implantation of epi-retinal prosthesis
UZ Ghent
Ghent, Belgium
UZ Leuven
Leuven, Belgium
Rabin Medical Center
Petah Tikva, Israel
Sourasky Medical Center
Tel Aviv, Israel
San Raffaele
Safety endpoint
Occurrence of serious adverse events related to the device and/or to the procedure
Time frame: within 9 months post implantation
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Milan, Italy
Fondazione Policlinico A. Gemelli, IRCCS
Rome, Italy