Results at 6 months
months follow-up results for the feasibility clinical study in France
The interim clinical results at 6 months follow-up with PRIMA bionic vision system, including the implantable wireless sub-retinal photovoltaic microchip, in patients with advanced atrophic dry-AMD, shows:
• PRIMA can be safely implanted under the atrophic macula while preserving the residual natural peripheral visual acuity, measured under standardized conditions (using microperimetry and ETDRS).
• Successful elicitation of light perception in the central retinal area in all subjects who had no remaining central visual activity, validated by standardized clinical vision measures and tests (Octopus visual field).
• The implant is well tolerated, with no device-related serious adverse events. Implant does not move after natural retina healing and remains stable in all patients.
• Identification of patterns, numbers, or letters, in majority of the patients. The speed and accuracy of identifications improved continuously during the rehabilitation phase.
• Central prosthetic visual acuity measured (with Landolt-C) up to 20/460 (LogMAR 1.37) within the former scotoma with no remaining natural central vision. The achieved prosthetic visual acuity to date is the best among those published from current visual prosthetic technologies.