Argus II – Invention of the World’s First FDA-Approved Artificial Retinal Prosthesis

USC Department of Ophthalmology Pasadena EyeAs a medical student, Dr. Mark Humayun knew his grandmother was slowly losing her vision due to complications from diabetes. Dr. Humayun’s approach was in essence from the bedside of his grandmother to the bench and back, devoting his life to finding solutions for devastating conditions that cause blindness. Dr. Humayun, both an ophthalmologist and bioengineer, along with his colleague Dr. James Weiland, assembled a team of world experts to create a revolutionary device known as Argus II. As co-inventors, they converged the concepts of both bioengineering and medicine to develop the Argus II retinal prosthesis system, which is a medical breakthrough for those suffering from an inherited form of retinitis pigmentosa (RP). There are more than 1.5 million people who have been diagnosed with different forms of RP worldwide. RP is a group of inherited retinal degenerative diseases that can lead to blindness, characterized by loss of the light sensing cells known as photoreceptors (rods and cones) and progressive scarring of the retina (back of the eye responsible for capturing images). Argus II is the world’s first FDA-approved artificial retina system that offers an unprecedented degree of sight to those with complete retinal blindness.

Argus II – The Technology

Patients who suffer from RP are unable to detect light due to the absence of photoreceptors. The Argus II restores the sense of sight with advanced bioelectronic technology. Commonly referred to as the “bionic eye,” the ophthalmic device is a retinal implant system (Images A & C) that consists of an eyeglass mounted camera and an implanted 60 electrode retinal stimulator. The stimulator, implanted

Dr. Mark Humayun
Dr. Mark Humayun

on the eye and interfacing directly to the retina, relays signals from the external camera to the retina via small electrical impulses, which triggers signals in the retina that are passed to the brain via the optic nerve. The brain is then able to process the signals into a visual picture (Image F).

Argus II – Real Life Impact

Lisa Kulik, was the first person to be implanted with the FDA approved, Argus II at USC Keck School of Medicine by Dr. Humayun and his team in June 2014. Lisa was blinded by an inherited form of RP and is now able to see after 30 years of complete darkness (Image D) following implantation.  Examination by Mark Humayun, PhD, MD, reported that Kulik was ahead of expectations as she was able to see spots of light on the first day of activation. Lisa Kulik celebrated this truly marvelous biomedical engineering feat by watching the Fourth of July fireworks (Image E). The image shown in (F) is what Argus II was able to capture for Lisa that day! During months of follow-up testing, Kulik will train her brain to see in a new way, interpreting the signals sent by Argus II.  Recently, USC Roski Eye Institute patient, Terry Byland, became the first person in the world to have two retinal implants; one in each eye.

headshot-Hossein-Ameri
Hossein Ameri, MD, PhD, Director

“I’m confident there will be a cure for blindness down the road and it starts here.” -Lisa Kulik

More than 30 research participants were included in the Argus II trial launched in 2007 at sites in the U.S. and Europe. It was approved by the U.S. Food and Drug Administration (FDA) in February 2013. The implant is available at more than 25 medical centers worldwide. The project was funded by National Institutes of Health (NIH)/National Eye Institute, Office of Science at U.S. Department of Energy, National Science Foundation, W.M. Keck Foundation, Research to Prevent Blindness. Currently, Second Sight Medical Products, Inc has commercially launched Argus II worldwide. As of the first quarter of 2015, 19 Argus II systems have been successfully implanted.             Dr. Hossein Ameri, assistant professor of clinical ophthalmology, is the principal investigator for the Argus II study which is presently enrolling.
See our video: https://www.youtube.com/watch?v=CF7YOBUthLY&index=5&list=PLLmPanrJp7igb6l4JZ3P77GhFtq-A_bxh

LA USC Roski Eye Institute Doctors
Dr. James Weiland

The Next Generation of Bionic Eye

Although the Argus II has achieved significant success, the amount of vision restored is limited. Better technology is needed to provide a richer sense of vision. To this end, research is being conducted on more sophisticated interfaces that can precisely target individual cells of the retina. New materials and compounds are under study to enable these devices. The external camera system, which currently performs only limited processing of the video data, is being transformed into a “smart camera” that can detect the important and relevant parts of the scene and alert the patient to these, while filtering out unimportant information. Using the Argus II development as an example, the current team of ophthalmologists, scientists and engineers are working together towards this next generation device.

 

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