Evaluation and inclusion Criteria


Evaluation Criteria



The principal evaluation criterion of the trial relies on performance evaluation, and is the elicitation of visual perception by electrical stimulation of the PRIMA implant and safety assessment including complication rates at 1 day, 1 week, 1.5, 3, 6, 12, 18, 24 and 36 months after implantation.

Inclusion Criteria


  • · Is 60 years or older at the date of enrollment;

  • · Has a confirmed diagnosis of advanced dry age related macular degeneration with an atrophy size of at least 3 optic disc diameters;

  • · Has best corrected visual acuity of the study eye of logMAR 1.3 (20/400) or worse measured by ETDRS; (beyond legal blindness)

  • · Has no foveal perception measured by micro-perimetry in the study eye (≤ 4 dB on Opko scale or equivalent);

All subjects agreeing to participate in the study are followed for at least 18 months, and up to 36 months. Other, more detailed, criteria apply and will be checked by the responsible ophthalmologist. For more information about the inclusion and exclusion criteria, please refer to the clinicalGov link to the study.