Evaluation Criteria

The principal evaluation criterion of the trial is the analysis of the incidence, severity and duration of all adverse effects after 1 day, 1 week, 1.5, 3, 6, 12, 18, 24 and 36 months.

The secondary evaluation criteria involve measuring visual perception to show the potential benefits of PRIMA. They are assessed by comparing the patients' capacity to carry out a visual task with and without the device (meaning the device is either on or off) 1.5, 3, 6, 12, 18, 24 and 36 months after implantation.

Performance before implantation is also determined.