Argus II Retinal Prosthesis System Post-Approval US Cohort 1 Year Outcomes

Abstract

Purpose : The Argus II Retinal Prosthesis System is the only approved treatment in the United States for patients with advanced retinitis pigmentosa and bare light perception vision. This prospective post-marketing surveillance study is the first report to evaluate the real world clinical outcomes of Argus II patients in the US.

Methods : We analyzed the patient demographic, intraoperative and postoperative serious adverse events (SEAs), and visual function performance including square localization, direction of motion, and grating visual acuity.

Results : Twenty-six patients (8 females and 18 males) in the Argus II post-approval study with at least one year of follow up as of October 31, 2016 were included for analysis. Average age at the time of surgery was 64 years old (range: 44-88). There were zero implant failures and zero explants. Five serious adverse events were device- or procedure-related as of October 31, 2016. There was a statistically significant improvement in Square Localization mean error was statistically significantly less with the System ON than when patients used only their residual vision (system OFF) in 45% (3 months), 47% (6 months), and 56% (12 months) of patients. Similarly, Direction of Motion was better with the System ON than with system OFF in 43% (3 months), 39% (6 months), and 29% (12 months) of patients. In the implanted eye, 14%-23% of patients had logMAR vision better than 2.9 with the device ON versus 0% with the device OFF at 3, 6, and 12 months.

Conclusions : In a post-approval setting, the Argus II appears to be safe and results in improved visual function in patients with advanced retinitis pigmentosa.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.