Evaluation Criteria

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

The secondary evaluation criteria involve measuring visual perception to show the potential benefits of IRIS®. 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) 3, 6, 12 and 18 months after implantation.

Initial performance (before implantation) is also determined.