Results at 6 months


6 months interim results presented at The Eye and The Chip, 2017

Compensation for Blindness with the Intelligent Retinal Implant System (IRIS II) in Patients with Retinal Dystrophy




Authors and participating centers

Mahi Muqit, Moorfields Eye Hospital NHS Foundation Trust, London, UK; Yannick Le Mer, Fondation Ophtalmologique A. De Rothschild, Paris, France; Michaela Velikay-Parel, Medical University of Graz, Austria; Michel Weber, CHU Nantes, France; Gerard Dupeyron, and Didier Audemard CHU Nimes France; Borja Corcostegui, IMO Institut de microcicurgia ocular, Barcelona, Spain.

Objective

To evaluate the safety and effectiveness of the Intelligent Retinal Implants System (IRIS II) manufactured by Pixium Vision SA, France.

Results

Upon switch-on post surgery, light perception was confirmed for all patients. At the 6-month time-point, there were 0.4 SAEs per patient.The data generated from the subjects showed improvements in the majority of tests. Square localization: 7/9 patients better with device (on vs. off) ; direction of motion: 8/9 patients better with device (on vs. off); picture recognition test: 7/9 patients better with device (on vs. off) ; Goldmann Visual field test: 5/9 patients better with device (on vs. off).

Conclusions

At 6 months follow-up, there were no SAEs that brought into question the long-term safety or biocompatibility of the device or the ability of the human to tolerate the device. The data generated from the ten subjects using the IRIS II device demonstrated a clear improvement of vision.

The 6-months follow-up of clinical safety and performance demonstrated that IRIS ® system improved visual performance of the implanted subjects and has a favorable safety profile. Although a shorter than expected lifespan of the implant was noted, improvements in implanted subjects’ quality of life and autonomy was demonstrated during this study. Continuing its research and development, Pixium Vision aims to harness state of the art technological innovations to achieve a continuous improvement of artificial bionic visual perception along with longer sustainable lifespan with next generation of its retinal implants.