gms | German Medical Science

Objective: The NR600 System (Nano Retina®) is a retinal prosthetic system intended to provide electrical stimulation to the retina to induce visual perception in patients with profound vision loss in both eyes due to degenerative retinal disease.

Materials and methods: The device is implanted by an epiretinal approach with ~600 electrodes that extend into the deep retinal layers. Fixation of the device into the retina is provided by a helical spring system fixated in the retro-iridal space. Image formation is generated by the device itself, without the need of an external camera. Powering of the device is done via infra-red illumination coming from dedicated spectacles.

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 degeneration diseases and severe visual impairment study.

Results: The study is designed as a prospective, single-arm, non-randomized, open label trial, and was approved by three European ethics committees. In vivo porcine experiments have shown that the device can be implanted safely, and well tolerated for 3-month follow-up.

Discussion: In the trial, patients will be included with visual acuity in both eyes from light perception to no light perception. The study follow-up will be 18 months. Safety endpoints are serious adverse events possibly related to the device and/or to the procedure. Performance endpoints are improvement in subject’s visual function, activity of daily living and quality of life. For the performance endpoints, the outcome measures will be compared with subject’s baseline measurements and between system ON and system OFF during follow-ups.

Acknowledgements: This clinical trial is sponsored by Nano-Retina.