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. Patie

SUBMITTER: da Cruz L 

PROVIDER: S-EPMC5035591 | biostudies-literature | 2016 Oct

REPOSITORIES: biostudies-literature