5-year clinical trial data published.
Data from the long-term clinical study of the Argus II retinal prosthesis, which was implanted in Italy a few years ago at the Careggi hospital in Florence, at the Azienda ULSS 15 Alto Padovana in Camposampiero (PD) and at the San Paolo hospital in Milan, have demonstrated its safety and effectiveness.
The Argus II (Second Sight) system uses electrical stimulation to bypass dead cells and stimulate the remaining viable retinal cells by inducing visual perception in people with severe or profound outer retinal degeneration. The Argus II works by converting images captured by a miniature camera mounted on the patient's glasses into a series of small electrical impulses, which are transmitted wirelessly to an electrode array implanted on the surface of the retina. These impulses are intended to stimulate the remaining cells of the retina, resulting in the perception of light patterns in the brain. The patient then learns to interpret these visual patterns, thus regaining partial visual function. The system is software-controlled and upgradeable, which can lead to improved performance as new algorithms are developed and tested.
The article published in Ophthalmology in July "Five years safety and performance results from the Argus II Retinal Prosthesis System Clinical Trial". follows the evaluation of 30 subjects in the clinical trial (NCT00407602) implanted with Argus II at 10 centres in the US and Europe. All patients were blind (i.e., lacking light perception or worse) due to Retinitis Pigmentosa (RP) or similar disease. During the five-year clinical trial, results showed that visual function improved after implantation with Argus II and these improvements were maintained for five years. Patients reported that the use of Argus II had a positive impact on their well-being and renewed relationship with their loved ones and the world around them. The results also showed that Argus II had an acceptable safety profile.
In the study, three types of visual function tests were performed by means of computerised exercises: square localisation (object vision), direction of movement (motion detection) and oriented grating distinction (visual acuity). Two types of real-world orientation and mobility (O&M) tests were also performed: one test required patients to locate and touch a door while the second required patients to follow a white line on the floor. The abilities to find a door and follow a line have real-world significance in relation to mobility, walking and safety.
The positive results of this long-term clinical study follow the long-term cost-effectiveness study on Argus II published in 2014. In that case, researchers assessed the costs of using Argus II over a 25-year period starting at age 46 (estimated average age of RP patients diagnosed legally blind) and found that the incremental cost for Argus II was approximately $16,000/quality-weighted life-years, well below the cost threshold for fee-for-service and usual care costs.
For more details see:
- Article Ophthalmology
- Article BMC Ophthalmology
Dr. Carmelo Chines
Direttore responsabile
English 
Italian