Clinical Follow-up

Clinical follow-up visits are planned at 1 day postimplantation, at weeks 1 and 2, and then at 1, 3, 6, and 12 months after the implantation (these visits will be modified in line with local routine practice, Table 1). In the event that COVID-19 precautions are in place, some clinical follow-ups may be carried out remotely where the treating clinician deems it is appropriate. Most of the visual function tests and measures will be conducted in both the implanted and fellow eye to provide data on the natural course of the participants’ vision loss and as a control for measurements of visual function. Testing will also compare visual function in the study eye with the device ON versus that in the study eye with the device OFF. The number of follow-up visits will be recorded. Unscheduled visits such as those required to address potential adverse events will also be recorded.