The purpose of this study is to test the Argus II Retinal Prosthesis System in patients with severe age-related macular degeneration (AMD). The Argus II System has already been studied in completely blind patients with retinitis pigmentosa (RP). In RP patients, some cells of the retina are irrevocably damaged and the Argus II System has been found to restore some basic visual function. On these grounds, the device has received authorization for use on the European market (the CE certification) in 2011.
In this study, 5 subjects with severe dry AMD who are legally blind will be implanted with the Argus II System. The study will evaluate the safety of the device and surgery, as well as functioning of the system and the extent of any restored vision. Each subject will be followed for 3 years, with their eye health and visual function tested at multiple time points.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
To evaluate the safety and effectiveness of the Argus II Retinal Prosthesis in subjects with AMD.
Manchester Royal Eye Hospital
Manchester, United Kingdom
Adverse Events
The number of adverse events in implanted subjects.
Time frame: Up to 1 year
Visual function
The primary effectiveness endpoint of the study is the effect of the Argus II System on monocular (implanted eye) and binocular visual function, as measured by a suite of visual function tests.
Time frame: 1 Year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.