בשל "הגנת זכויות יוצרים", מובא להלן קישור למאמר בלבד. לקריאתו בטקסט מלא, אנא פנה לספרייה הרפואית הזמינה לך.
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.
collect postapproval safety and visual function data for the Argus II.
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 implantation.
The primary end point of this study was the nature and rate of adverse events. Secondary end points included 3 visual function tests: square localization (SL), direction of motion, and grating visual acuity (GVA).