Evaluation and inclusion Criteria

Evaluation criteria

The principal evaluation criteria of the trial relies on safety evaluation, and is the analysis of the incidence, severity and duration of all adverse effects after 3, 6, 12 and 18 months following the IRIS® II implantation, and up to 36 months in the study extension, subject to patient consent.

The secondary evaluation criteria relies on effectiveness and involves measuring visual perception to show the potential benefits of IRIS® II. They are assessed by comparing the patients' capacity to carry out a visual task with and without the device at 3, 6, 12 and 18 months after implantation.

Initial performance (before implantation) is also determined.

Inclusion criteria

• Subject is at least 25 years old at the date of enrolment;

• Has a confirmed diagnosis of Retinitis Pigmentosa (RP), Choroideremia or Cone-Rod Dystrophy;

• Has a visual acuity of logMAR 2.3 or worse in both eyes as determined by a Square Grating scale;

• Has functional ganglion cells and active optic nerve activity;

• Understands and accepts the obligation to attend all scheduled follow-up visits.

Other, more detailed, criteria apply and were checked by the responsible ophthalmologist.

For more information about the study, please refer to the clinicalGov link to the study.