Evaluation and inclusion Criteria


Evaluation Criteria


European (France) feasibility study ClinicalTrials.Gov NCT 03333954

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 after implantation. 

USA (Pittsburgh) feasibility study ClinicalTrials.Gov NCT 03392324

The principal evaluation criterion of the trial rely on performance evaluation which is the Elicitation of visual perception by electrical stimulation of the PRIMA implant and complication rates, at 12 months after implantation. Secondary endpoints include visual perception at 3,6,9,18, 24 and 36 months,visual acuity measured by ETDRS, near visual acuity measured by FrACT at 3,6,9,12,18,24 and 36 months, and reading acuity measured at 12, 18, 24 and 36 months after implantation.

Main Inclusion Criteria



Europe (France) ClinicalTrials.Gov NCT 03333954


  • · 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 20/400 (logMAR 1.3) 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);

USA (Pittsburgh) ClinicalTrials.Gov NCT 03392324

  • · 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 logMAR 1.3 (20/400) or worse in both eyes measured by ETDRS;
  • . Has a central scotoma in the study eye with no perception at 0 dB on MP-1 micro-perimetry scale;
  • . Has a refraction of study eye between -3 and + 4 (limits included) for patients with IOL (there is no refraction criteria for phakic patients);

These are abstracts of the main inclusion criteria for both studies. For more information about the inclusion and exclusion criteria, please refer to the ClinicalTrials.Gov link to the study.

All subjects agreeing to participate in the study will be followed for up to 36 months after implantation. Other, more detailed, criteria apply and will be checked by the responsible ophthalmologist.