This article is more than 5 years old. Information may no longer be current.
Argus II retinal prosthesis system safe, beneficial at 3 years
Click Here to Manage Email Alerts
The Argus II retinal prosthesis system showed favorable results at 3 years in patients with retinitis pigmentosa who experience blindness, according to a study.
The single-arm, prospective, unmasked clinical trial included 30 patients who were implanted with the Argus II (Second Sight Medical Products) in a single eye at 10 centers throughout the United States and Europe. Twenty-nine patients had retinitis pigmentosa, and one patient had choroideremia; 29 patients had bare light perception, and one patient had no light perception.
Researchers performed three visual function tests (square localization, direction of motion and grating visual acuity) and two real-world orientation and mobility tests (door task and line task) on patients, as well as a Functional Low-vision Observer Rated Assessment (FLORA). The FDA requested the development of the FLORA to assess real-world benefits of the Argus II system.
At 3 years after implantation, 29 patients continued to have a functioning Argus II implant. A total of 23 serious adverse events were reported in 11 patients; 14 occurred within the first 6 months after implantation, and five occurred after 1 year.
“Generally, ophthalmic adverse events may be a concern because of the possibility of further vision loss; in these patients, residual vision is negligible, thus reducing the risk posed by these adverse events,” the study authors said.
Regarding visual function results, 89% of patients performed better with the Argus II on than off for square localization, 56% for direction of motion and 33% on the scale on grating visual acuity.
There were no device failures 3 years after implantation. – by Nhu Te
Disclosure: Ho reports he is a consultant and paid researcher for Second Sight Medical Products. Please see the full study for a list of all other authors’ relevant financial disclosures.
Collapse
Ho AC, et al. Ophthalmology. 2015;doi:10.1016/j.ophtha.2015.04.032.
Click Here to Manage Email Alerts