First-Ever Bionic Eye Implanted in Two Blind Patients

2014-01-30_15-46-42

Researchers at the University of Michigan’s Kellogg Eye Center have implanted the world’s first retinal prosthesis, or bionic eye, in two patients that had lost all vision to an optic disease called retinitis pigmentosa. The device, called the Argus II, was developed by Mark Humayun, MD, an ophthalmologist and biomedical engineer at the University of Southern California.  Humayun went on to launch Sylmar, Calif.-based Second Sight Medical Products to commercialize his findings.

Argus II became the first FDA approved treatment for blindness in February 2013. Prior to FDA approval, the device was field tested on about 50 people both in the US and in Europe. Users report that images are not perfect, but the device does allow them to see oncoming cars, and recognize approaching people.

During the application process, the FDA worked with Second Sight to develop new ways of measuring the risk vs. benefit of the device. The tasks it included were walking on a sidewalk without stepping off; matching black, gray and white socks; and reading letters on a computer screen. The FDA eventually approved the Argus II for treatment of end-stage reginitis pigmentosa, a condition that is defined as having “bare light” or no light perception in both eyes.

“The questions that this particular device raised for FDA were very new. It’s a big step forward for the whole ophthalmology field.” – Malvina Eydelman, MD, FDA director for the Division of Ophthalmic and Ear, Nose, and Throat Devices.

Retinitis pigmentosa is a degenerative disease that erodes the retina’s ability to detect and transmit the presence of light to the brain. To address this problem, researchers created a system that can capture the presence of light and dark in a patients field of vision, and then amplifying that image and imprint it directly on the damaged retina. By amplifying the signals, the remaining healthy retina is able to recognize image and transmit it to the brain.

For the system to work, users wear a pair of glasses outfitted with a video recorder. Images are captured by the recorder and then sent to a computer worn on the hip, where the images are converted into a series of pixels that can be wirelessly transmitted to an implanted chip in the eye. The chip is actually a sheet of electrodes that presents the images in the form of rudimentary black and white dots in the wearers field of vision, bypassing the damaged retina, and replicating, at a very basic level, the retina’s function.

Thiran Jayasundera, M.D., and David N. Zacks, M.D., Ph.D. performed the surgery. Following the procedure, Dr. Jayasundera said "We are pleased with both patients’ progress at this point, and we are hopeful and optimistic that the artificial retina will enable them to see objects, light and people standing before them. We believe the device will help them navigate a little better at home, be more independent, and have the pleasure of seeing things that the rest of us take for granted.”


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