It’s taken three years, but the recent results of an extended clinical trial have shown that a bionic eye developed by American researchers isn’t only safe, but it can actually restore vision in those with degenerative eye diseases like retinitis pigmentosa(1).
The results, published in the journal Opthamology, found that almost 90% of the trial subjects could see better after using the device.
Known as Argus II, the bionic eye significantly improved the quality of life of 80% of trial participants(2).
The discovery is being hailed as a step forward in assistive technology, similar to the cochlear implant – a device which has restored hearing to hundreds of thousands of deaf and hard-of-hearing individuals(3).
How It Works
The Argus II system was designed to restore some functional vision to individuals living with retinitis pigmentosa, which affects about one in 4,000 Americans. The disease causes vision loss which eventually leads to total blindness.
Through the device, patients are able to see patterns of light, which the brain is then able to interpret as images. A miniature video camera stored in the patients glasses sends visual information to a small video processing unit, which is small enough to be stored in a pocket.
The video processing unit them turns the image to electronic signals, which are transmitted wirelessly to an electronic device implanted in the patient’s retina.
Ensuring Patient Safety
In 2013, the Argus II was given approval by the US Food and Drug Administration for use as a Humanitarian Use Device, or HUD.
But researchers needed to make sure that the device was totally safe to use, with no long-term health consequences for patients.
So a small clinical trial of 30 patients, between the ages of 28 and 77, was conducted over the past 3 years in the United States and Europe.
While 89 percent of the trial participants found that their vision improved significantly with the device, a Functional Low-vision Observer Rated Assessment (or FLORA) found that 80 percent of trial participants not only received a benefit of better vision, but better overall quality of life as well – and none of the trial subjects reported any adverse effects that were not successfully treated.
A Viable Treatment Option
In a recent press release, Allen C. Ho, the lead author of the study and director of the clinical retina research unit at Wills Eye Hospital, expressed hope that the Argus II could be considered a potential treatment option for future patients.
“This study shows that the Argus II system is a viable treatment option for people profoundly blind due to retinitis pigmentosa – one that can make a meaningful difference in their lives and provides a benefit that can last over time,” he said.
“I look forward to future studies with this technology which may make possible expansion of the intended use of the device, including treatment for other diseases and eye injuries.”(4)