New Enrollment Post-Approval Study of the
Argus II Retinal Prosthesis System
This is a controlled (with Argus II System turned ON and OFF) prospective, multi-center post HUD approval study. The objective is to study the overall safety and utility results for the Argus II System implanted in the general population and are the safety and utility results similar or different to results from observed subjects enrolled in the pre-market study. There will be a total of 53 participants, blind from retinitis pigmentosa and implanted with the HUD Argus II System, that will be asked to enroll. It is anticipated that 85% of subjects will complete 5 years follow-up. This will provide a sample size of 45 subjects with complete 5 year follow-up. A minimum of 5 and a maximum of 20 centers in the US will participate in this study. The participant will have tests and exams including review of medical history, medical exam, eye exam, grating visual acuity, square localization, direction of motion, ultrasound, and flash test. They will have the option to undergo photography, and imaging.They will have the exam at 8 follow up visits: 1month, 3month, 6month, 1yr, 2yr, 3yr, 4yr, 5yr.The study endpoints are Primary: Safety (i.e. adverse event rates), with the main safety analysis performed when all subjects have reached 2 years post-implant. Secondary: Visual function, functional vision, and device reliability. Statistics: Descriptive summaries will be provided for all data including subject demographics, adverse events, visual function, and functional vision.Continuous variables will be summarized with their means, medians, standard deviations, and ranges over time. Categorical variables will be summarized with their proportions and confidence intervals.