Yesterday, the Food and Drug Administration approved the nation's first treatment to open a new window in health and restore partial sight to the blind.
The new "bionic eye" is a microelectronic implanted visual prosthesis. It is designed to restore useful vision in partly or totally blind individuals, and it works best in people who lost sight sometime after birth, when the optic nerve has fully developed. Ophthalmology surgeons have successfully implanted the bionic eye in patients years or decades after the onset of their blindness.
Drs. Mark Humayun and Eugene DeJuan at USC's Doheny Eye Institute, Dr. Robert Greenberg of Second Sight Medical Products, and Bioelectronics engineer Wentai Liu at University of California, Santa Cruz, invented the active epi-retinal prosthesis. They first used it in acutely impaired patients at the Johns Hopkins University in the early 1990s.
The FDA has licensed Second Sight's Argus II device for treatment of severe retinitis pigmentosa, a disease in which a person's photoreceptor (light-perceiving) cells deteriorate. This type of blindness affects about 100,000 Americans. The retinal implant system is expected to have significant benefits also for two million people who have either inherited retinal degenerative disease or age-related macular degeneration.
The prosthesis works through the body's neural network much the same as the cochlear implant, which has reduced deafness since the mid-1980s. The eye implants provide sight using a tiny video camera mounted on a special pair of glasses. A flexible sheet of electrodes implanted at the back of the eye picks up the images and sends their signal to undamaged retinal nerve cells. They then pass it on to the wearer's optic nerve and brain. The implants do not produce full vision, but they allow users to see whether lights are on or off, follow an object’s motion, count individual items, and locate objects within their environment.
Bionic eyes will be available first at seven hospitals in New York, California, Texas, Maryland, and Pennsylvania. The implants will cost about $150,000, exclusive of surgery and training expenses.
Future applications
Researchers hope to move up to a significantly larger array of electrodes over the next few years. Perhaps within a decade, they may progress to a thousand-electrode implant that will allow its users to recognize faces, see image details, and read ordinary type.
Because the bionic eye enables machines to communicate with a body's neural cells, many other biomedical devices may be enabled in future by the new technology. Similar electrodes may one day be used to correct bladder control problems and even treat spinal paralysis.
The same mechanisms used in the artificial retina may also prove adaptable to other cell types, such as those of plants and bacteria. Investigations are ongoing. These applications could be game-changing: remote sensors that could monitor for environmental contamination, assist with environmental remediation, or counter bioterrorism.
Development through collaborative, multi-institutional effort
The Artificial Retina Project began developing final technology on October 14, 2004 from the work of the four inventors. Three major government agencies (the Department of Energy, the National Eye Institute, and the National Science Foundation) funded clinical testing of the bionic eye. The research team included six DOE national laboratories, four universities, and private industry. The device was approved for commercial use in Europe in the spring of 2011 and passed by the U.S. FDA on Valentine's Day, 2013.
Other bionic eyes are under development by different organizations but not yet U.S. government-approved.
Based in Chicago, Sandy Dechert has been covering health stories for Examiner.com since the online zine's official startup. She has reported on limb prosthetics, the 2012-2013 influenza epidemic, top women's health news of 2012 (including prevention), athletic injury, and the fungal meningitis outbreak.
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