One-Year Safety and Performance Assessment of the Argus II Retinal Prosthesis: A Postapproval Study.

ABSTRACT:

Importance

The Argus II Retinal Prosthesis System is indicated for patients with vision loss due to severe to profound outer retinal degeneration, a group with few treatment options.

Objectives

To collect postapproval safety and visual function data for the Argus II.

Design, setting, and participants

Multicenter, postapproval clinical trial conducted at 9 sites in Germany and Italy. Data were collected from December 2, 2011, to September 30, 2017, and patients were followed-up for 12 months or longer. Patients were 25 years or older with severe to profound outer retinal degeneration, some residual light perception or the ability of the retina to respond to electrical stimulation, and a history of useful form vision and were already planning to undergo Argus II implant

SUBMITTER: Schaffrath K 

PROVIDER: S-EPMC6547244 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature