It's been dubbed the “bionic eye,” a device that can restore some vision for people who are blind and suffer from a rare genetic eye disorder.
The Argus II Retinal Prosthesis System is one of the first times that a device that can restore vision for people who are blind has been approved in the U.S.
And now that the technology's been approved, it might be the first of many developments of its kind.
“It's the most complex device that's ever been put inside an eye for any type of eye disease,” said Dr. Sam Dahr, a retina surgeon at Integris Baptist Medical Center. “Not only does the device offer hope for retinal degeneration, but many of the engineering principles and breakthroughs that came with the development of this device may hopefully be extended to other retinal diseases in the future as well.”
Dahr served on the U.S. Food and Drug Administration's team that reviewed the Argus II for FDA approval. The Argus II was approved by the FDA in February for treating patients with a disease known as advanced retinitis pigmentosa.
Retinitis pigmentosa is an eye disease in which the retina, the layer of tissue at the back of the eye, is damaged, according to the National Institutes of Health. It is an uncommon condition affecting about 1 in 4,000 people in the United States, according to the NIH.
Symptoms appear in childhood but, generally, severe vision problems don't develop until early adulthood, according to the NIH. People with retinitis pigmentosa can develop decreased vision at night or in low light; loss of peripheral vision, which causes tunnel vision; and the loss of central vision, according to the NIH.
Meaning: some can go blind.
Treatment options have been limited. There's no guarantee that the Argus II will be quickly available in Oklahoma. So far, no hospital or other medical facility has it, Dahr said.
It will be up to the company to determine which hospitals and centers receive the Argus II for patients, Dahr said.
Rather than calling it a “bionic eye,” the Argus II is more accurately described as a prosthetic for the eye, Dahr said.
The Argus II has not yet proved to completely restore a person's vision. Rather, it allows patients who were blind or almost blind to see shapes and patterns. For example, a person with the Argus II might be able to distinguish where a door is or where a couch in their house is. But they likely couldn't read a book with small print.
The way the Argus II works is through a small video camera, a transmitter mounted on a pair of eyeglasses, a video processing unit and an implanted retinal prosthesis, or artificial retina, according to the FDA.
This device replaces the function of degenerated cells in the retina and might improve a patient's ability to perceive images and movement, according to the FDA. The video processing unit transforms images from the video camera into electronic data that is wirelessly transmitted to the retinal prosthesis, which is inside the eye, according to the FDA.
There are potential risks associated with the Argus II. A person must undergo extensive surgery to have the device implanted. There's a risk that the eye could become infected. If this happened, the device might have to be removed and implanted again once the infection is gone.
There's a risk that the layer of the skin that covers the device could erode, he said. This can be treated by resuturing the skin layer of the eye, he said.
Also, there's a risk of retinal detachment, in which the retina separates from the layers that support it, according to the NIH.
Dr. Robert E. Anderson, director of research at Dean McGee Eye Institute, said the Argus II is an exciting first step that offers promise but added developments like these take time.
“It offers the promise of some useful vision for people who are now completely blind or who have, at best, light perception,” Anderson said. “The device, by its very nature, is not sophisticated enough, and these probably never will be in the near future, to allow people to read a newspaper or watch television.”
However, for someone who, at best, can tell whether lights are on or off, having the ability to see a form, perceive motion, see a curb or find a door is a huge advantage, he said.
“Especially if they're blind to the point where they use a cane, and having just that amount of vision will be of great benefit to them,” he said.
Anderson said Second Sight isn't the only company that has worked to develop a device like the Argus II. Companies across the world are researching how to develop a device like the Argus II that's independent of the camera, he said.
Scientists have been working to develop this type of technology for the past 20 years, he said.
“There are other ways of perhaps replacing the cells that are dead or, before people go blind, finding ways to slow down the progression of the disease, but this is a new treatment that we now have and can offer a limited number of people,” he said. “Hopefully, as time progresses, it will become generally available to those who qualify.”