Five-Year Safety and Performance Results from the Argus II Retinal Prosthesis System Clinical Trial

Abstract

Purpose: The Argus II Retinal Prosthesis System (Second Sight Medical Products, Inc, Sylmar, CA) was developed to restore some vision to patients blind as a result of retinitis pigmentosa (RP) or outer retinal degeneration. A clinical trial was initiated in 2006 to study the long-term safety and efficacy of the Argus II System in patients with bare or no light perception resulting from end-stage RP.

Design: Prospective, multicenter, single-arm clinical trial. Within-patient controls included the nonimplanted fellow eye and patients' native residual vision compared with their vision with the Argus II.

Participants: Thirty participants in 10 centers in the United States and Europe.

Methods: The worse-seeing eye of blind patients was implanted with the Argus II. Patients wore glasses mounted with a small camera and a video processor that converted images into stimulation patterns sent to the electrode array on the retina.

Main outcome measures: The primary outcome measures were safety (the number, seriousness, and relatedness of adverse events) and visual function, as measured by 3 computer-based, objective tests. Secondary measures included functional vision performance on objectively scored real-world tasks.

Results: Twenty-four of 30 patients remained implanted with functioning Argus II Systems at 5 years after implantation. Only 1 additional serious adverse event was experienced after the 3-year time point. Patients performed significantly better with the Argus II on than off on all visual function tests and functional vision tasks.

Conclusions: The 5-year results of the Argus II trial support the long-term safety profile and benefit of the Argus II System for patients blind as a result of RP. The Argus II is the first and only retinal implant to have market approval in the European Economic Area, the United States, and Canada.

Figure 1

Argus II System. A. Photograph of the implanted components of the Argus II System. B. The external (body-worn) components of the System.

Figure 2

Results for A. Square Localization, and B. Direction of Motion, and C. Grating Visual Acuity at yearly time points. A and B: Mean error with the System ON is shown as blue squares; mean error with the System OFF (with residual vision only) is shown as black diamonds. Error bars indicate standard error. C: The percent of patients scoring 2.9 logMAR or better on Grating Visual Acuity with the System ON (in the implanted eye) are shown at each time point. There were no patients who scored 2.9 logMAR or better with the System OFF in the implanted eye.

Figure 3

Mean Percent Success on the Door Task (A) and Line Task (B) with the System ON (blue squares) and System OFF (residual vision only, black triangles). Error bars indicate standard error of the mean.