Results from a clinical trial of Argus II, the only retinal prosthesis in the world to achieve approval for implant in Europe, have demonstrated the implant’s ability to improve vision.
A total of 30 patients were implanted with the prosthesis and followed up for a minimum of six months and up to 2.7 years.
Subjects performed statistically better with the Argus II system on, versus off, in the visual tasks:
• 96 per cent of subjects improved in object localisation
The results…showed that the previously blind subjects performed better at visual tasks with the Argus II system
• 57 per cent of subjects improved in motion discrimination
• 23 per cent of subjects improved in the discrimination of oriented gratings.
In addition, significant improvements in the orientation and mobility tasks were noted and the safety profile of Argus II was found to be comparable to other ophthalmic devices and procedures. Although there are several research efforts in retinal prostheses worldwide, none has demonstrated the reliability and efficacy of such a device in a multicentered, long-term, controlled clinical trial involving 30 subjects, as was demonstrated by the Argus II in this study.
“The Argus II can, quite simply, help the blind see,” said Dr. Stanislao Rizzo, Director of the U.O. Chirurgia Oftalmica, Azienda Ospedaliero Universitaria Pisana of Pisa, and the first surgeon to implant Argus II following European market approval. “Having an approved device backed by significant clinical data is cause for great hope among those patients suffering from RP. There is finally a real solution that means that their vision can be partially restored, safely.”
“The results from the trial demonstrated long-term reliability and showed that the previously blind subjects performed better at visual tasks with the Argus II system such as object localisation and motion discrimination. The best visual acuity achieved by a subject in this study was 1.8 logMAR (Snellen equivalent, 20/1262), a substantial visual improvement over blindness,” said Mark Humayun, MD, PhD, Professor of Ophthalmology, Biomedical Engineering at Doheny Eye Institute, at University of Southern California, lead author of the study published this month by Ophthalmology.
The Argus II was approved for implant in Europe in February 2011.