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

Area of Science:

• Ophthalmology
• Biomedical Engineering
• Medical Devices

Background:

• The Argus II Retinal Prosthesis System offers a treatment option for severe to profound outer retinal degeneration, addressing a critical unmet need.
• This study focuses on collecting postapproval safety and visual function data to further understand the device's real-world performance.

Purpose of the Study:

• To evaluate the safety and visual function outcomes of the Argus II Retinal Prosthesis System in a postapproval clinical setting.
• To collect data on adverse events and assess visual performance in patients with outer retinal degeneration.

Main Methods:

• A multicenter, postapproval clinical trial involving 47 patients aged 25 years or older with severe to profound outer retinal degeneration.
• Data collected from December 2011 to September 2017, with follow-up of 12 months or longer.
• Primary endpoint: incidence and nature of adverse events. Secondary endpoints: square localization, direction of motion, and grating visual acuity.

Main Results:

• 49% of patients experienced nonserious adverse events, and 26% experienced serious adverse events (SAEs) within 12 months.
• The most common SAE was conjunctival erosion (4 patients).
• Patients demonstrated improved performance on square localization and grating visual acuity tests when the Argus II was active compared to when it was off.

Conclusions:

• Safety and visual function results align with previous findings, suggesting consistent performance in a clinical practice setting.
• Longer follow-up and additional patient data are necessary to comprehensively define the risk-benefit profile of the Argus II.
• The Argus II shows potential for addressing blindness caused by severe-to-profound outer retinal degeneration.