Lab team makes unique contributions to the first bionic eye

The Argus II will help people blinded by the rare hereditary disease retinitis pigmentosa or seniors suffering from severe macular degeneration.

As part of the multi-­institutional Artificial Retina Project, Los Alamos researchers helped develop the first bionic eye. Recently approved by the U.S. Food and Drug Administration, the Argus II will help people blinded by the rare hereditary disease retinitis pigmentosa or seniors suffering from severe macular degeneration—diseases that destroy the light-­sensing cell in the retina. Los Alamos scientists served as the Advanced Concepts team, focusing on fundamental issues and out-­of the box ideas.

Significance of the research

The Argus II operates by using a miniature camera mounted in eyeglasses that captures images and wirelessly sends the information to a microprocessor (worn on a belt) that converts the data to an electronic signal. Pulses from an electrode array against the patient’s retina in the back of the eye stimulate the optic nerve and, ultimately, the brain, which perceives patterns of light corresponding to the electrodes stimulated. Blind individuals can learn to interpret these visual patterns.

Los Alamos research achievements

The Los Alamos team examined how visual information is encoded in the pattern of electrical impulses traveling the optic nerve. The scientists developed better ways to visualize and interpret the resulting neural activity patterns when the retina is stimulated.

Using high-­performance video cameras and near-­infrared illumination, the Los Alamos team imaged tiny changes in the light scattering and birefringence properties of neural tissue that are associated with nerve electrical activity, the retina that were produced by stimulation. The team also advised the consortium on the use of compatible technologies to map the human brain function stimulated by the devices or by normal biological vision.

The Laboratory team developed  theory—supported with experimental data—of how electrical activity of nerve cells produces polarized light signals that were used to image retinal function. They created a computer model of the retina directly predicting the dynamics of retinal neurons firing as function of patterns of stimulation. They also created theoretical models of the response of nerve cells to electrical stimulation, which suggest new strategies to stimulate patterns of neural activity with higher resolution and a greater specificity, useful to a wider range of individuals with visual impairment.

The need to improve the retina and electronics interface was the largest technical recording and stimulating arrays, and developed new techniques for coating electrode arrays that might enable advanced neural interfaces in the future, with many more channels and greater tolerance for the challenging environment of electronics implanted in biological tissue.

About the Artificial Retina Project

The DOE Artificial Retina Project is a multi-­institutional collaborative effort to develop and implant a device containing an array of microelectrodes into the eyes of people blinded by retinal disease. The ultimate goal is to design a device to help restore limited vision that enables reading, unaided mobility and facial recognition.

The 10-­year project involved researchers from DOE national laboratories (Argonne, Lawrence Livermore, Los Alamos, Oak Ridge, and Sandia), universities (Doheny Eye Institute at the University of Southern California, California Institute of Technology, North Carolina State University, University of Utah, and the University of California—Santa Cruz), and private industry (Second Sight Medical Products, Inc.). Members of the Los Alamos artificial retina team include team leader John George and members Garrett Kenyon, Michael Ham, Xin-­cheng Yao, David Rector, Angela Yamauchi, Beth Perry, Benjamin Barrows, Bryan Travis, Andrew Dattelbaum, Jurgen Schmidt, James Maxwell and Karlene Maskaly.

The DOE Office of Science funded the Los Alamos portion of the Artificial Retina Project. Laboratory Directed Research and Development (LDRD), the National Institutes of Health and the National Science Foundation have sponsored different aspects of basic R&D on neuroimaging, computational modeling and analysis of neural function, and materials and fabrication techniques that enabled the Los Alamos role in this project. The work supports the Lab’s Global Security mission area and the Science of Signatures and Information, Science, and Technology science pillars.

Bionic eye prototype unveiled by Victorian scientists and designers

A team of Australian industrial designers and scientists have unveiled their prototype for the world’s first bionic eye.

It is hoped the device, which involves a microchip implanted in the skull and a digital camera attached to a pair of glasses, will allow recipients to see the outlines of their surroundings.

If successful, the bionic eye has the potential to help over 85 per cent of those people classified as legally blind. With trials beginning next year, Monash University’s Professor Mark Armstrong says the bionic eye should give recipients a degree of extra mobility.

"There’s a camera at the front and the camera is actually very similar to an iPhone camera, so it takes live action for colour," he told PM. "And then that imagery is then distilled via a very sophisticated processor down to, let’s say, a distilled signal.

"That signal is then transmitted wirelessly from what’s called a coil, which is mounted at the back of the head and inside the brain there is an implant which consists of a series of little ceramic tiles and in each tile are microscopic electrodes which actually are embedded in the visual cortex of the brain."

Professor Armstrong says is it is hoped the technology will help those who completely blind, enabling them to navigate their way around.

"What we believe the recipient will see is a sort of a low resolution dot image, but enough… [to] see, for example, the edge of a table or the silhouette of a loved one or a step into the gutter or something like that," he said.

"So the wonderful thing, if our interpretation of this is correct - because we don’t know until the first human trial - [is] it’ll of course enable people that are blind to be reconnected with their world in a way.

"There’s a number of different settings … so you could set it to floor mapping for example and it creates a silhouette around objects on the floor so that you can see where you’re going."

A challenge the designers have had to overcome is ensuring the product was lightweight, adjustable and enabled users to feel good about themselves.

"We want to make it comfortable and light weight and adjustable so that different sized heads and shapes will still manage it well and have those sort of nice aspects," Professor Armstrong said.

"We don’t want a Heath Robinson wire springs affair on somebody’s head.

"It needs to look sophisticated and appropriate, probably less like a prosthetic and more like a cool Bluetooth device."

The first implant is scheduled to go ahead next year which is expected to be followed by clinical trials, research and user feedback to the team.

The development of a bionic eye was one of the key aspirations out of the 2020 summit that was held in 2008.

Professor Armstrong says it is “amazing” that a prototype for the technology has already been achieved.

"To be honest when I heard about that 2020 conference and all of the people there, I thought it was a little bit of a hot air fest if you know what I mean," he said.

"But I’ve been proven completely wrong.

"Some of the initiatives from that, this is a major one for sure, have been brought to fruition and it’s wonderful for Australia and equally wonderful for Monash University."

What It’s Like to See Again with an Artificial Retina

Elias Konstantopoulos gets spotty glimpses of the world each day for about four hours, or for however long he leaves his Argus II retina prosthesis turned on. The 74-year-old Maryland resident lost his sight from a progressive retinal disease over 30 years ago, but is able to perceive some things when he turns on the bionic vision system.

“I can see if you are in front of me, and if you try to go away,” he says. “Or, if I look at a big tree with the system on I can maybe see some darkness and if it’s bright outside and I move my head to the left or right I can see different shadows that tell me there is something there. There’s no way to tell what it is,” says Konstantopoulos.

A spectacle-mounted camera captures image data for Konstantopoulos; that data is then processed by a mini-computer carried on a strap and sent to a 60-pixel neuron-stimulating chip that was implanted in one of his retinas in 2009.

Nearly 70 people around the world have undergone the three-hour surgery for the retinal implant, which was developed by California’s Second Sight and approved for use in Europe in 2011 and in the U.S. earlier this year (see “Bionic Eye Implant Approved for U.S. Patients”). It is the first vision-restoring implant sold to patients.

Currently, the system is only approved for patients with retinitis pigmentosa, a degenerative eye condition that strikes around one in 5,000 people worldwide, but it’s possible the Argus II and other artificial retinas in development could work for those with age-related macular degeneration, which affects one in 2,000 people in developed countries. In these conditions, the photoreceptor cells of the eye (commonly called rods and cones) are lost, but the rest of the neuronal pathway that communicates visual information to the brain is often still viable. Artificial retinas depend on this remaining circuitry, so cannot work for all forms of blindness.

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Bionic eye maker has vision of the future

Robert Greenberg got tired of hearing from senior engineers that it wasn’t possible to build his product idea: a bionic eye that gives sight to the blind.

"A lot of the folks straight out of school didn’t know any better, so I hired them instead," quipped Greenberg, chief executive of Second Sight Medical Products Inc., a Sylmar biotech company. "They didn’t know how hard it was going to be, that it was impossible. And so they tried."

Greenberg can laugh now that he once thought developing the device would take a year and $1 million. Some 20 years and $200 million later, the first bionic eye has helped more than 20 European patients regain some of their sight.

Called the Argus II Retinal Prosthesis System, the device recently was approved by the Food and Drug Administration. Second Sight, which has 100 employees, is allowed to sell the bionic eye system to patients in the U.S. with advanced retinitis pigmentosa, a degenerative eye disease that can cause blindness.

"We are a far cry from restoring 20/20 vision," said Brian V. Mech, Second Sight’s vice president of business development, who holds a doctorate in materials science and an MBA from the UCLA Anderson School of Management.

"We are taking blind people back up to low vision, and that is pretty significant."

Mech likes to show videos of once-sightless patients who, after receiving the retinal prosthesis, are able to follow a person walking down the street and discern a street curb without using their canes.

"Until our product, these patients had no other option to obtain the ability to see," Mech said of the $100,000 device, part of which rests on a pair of Oakley Inc. sunglass frames. The cost to European patients has been paid by insurance companies in most cases.

Palo Alto attorney Dean Lloyd, who lost his vision 17 years ago, got the bionic eye system as part of the U.S. testing process. It allows him to see “boundaries and borders, not images” but has had a profound effect on his life.

Lloyd cites an incident before he received the eye system that still rankles. In the middle of a courtroom trial, an opposing attorney said Lloyd didn’t stand a chance with his case because he couldn’t even keep his socks straight: Lloyd had mixed up his black, courtroom socks with his white athletic ones.

"What did I do after the surgical procedure that I hadn’t been able to do?" Lloyd said. "I went home and sorted all of my socks."

The story of how the bionic eye came to be made in Sylmar underscores the state’s long record of medical device advances and involves top university researchers who were brought to Southern California to work on the project.

Greenberg likened the degree of difficulty to “shrinking a television set to the size of a pea, then throwing it into the ocean and expecting it to work.”

For Greenberg, it began in the early 1990s when he was a doctoral candidate in the Department of Biomedical Engineering at Johns Hopkins University in Baltimore.

Some of the first work was being done there, testing patients who had lost their vision because of retinitis pigmentosa, to see if electrically stimulating their retinas would produce results. It did.

"Using one electrode, the patient saw one spot of light," Greenberg said. "Second electrode, and the patient was seeing two spots of light. During that experiment, I was hooked."

Greenberg said he thought: “This is just engineering. Put more spots and you could make more pixels, like lights on a scoreboard or pixels on your computer monitor. You could see images.”

There was a breakthrough of another sort a few years later, in Washington. There, Greenberg was working as a medical officer and a lead reviewer for the FDA’s Office of Device Evaluation when he met entrepreneur Alfred E. Mann.

Mann had already established himself as a medical device developer through Mannkind Corp. and several other Southern California companies. During the 1980s, the self-made billionaire founded Pacesetter Systems, which made cardiac pacemakers. From there, he moved on to insulin pumps and related equipment.

Another Mann-funded company, Advanced Bionics Corp., took on cochlear implants, which could restore hearing to the deaf. It was the electrode-based cochlear implant that formed the rough basis of Second Sight’s first bionic eye.

In 1998, Second Sight opened with the financial backing of Mann and Sam Williams, another successful entrepreneur whose company, Williams International, designed and built small, efficient turbofan jet engines.

"Sam Williams was blind from retinitis pigmentosa, the disease that we are treating," Mech said. "He had invested along with Al in Advanced Bionics, which restores hearing for deaf people, and they were already on the market in the ’90s. Sam said to Al, ‘Why can’t we do the same for blind people?’"

Retinal implant wins FDA approval

The U.S. Food and Drug Administration (FDA) approved the Argus II retinal prosthesis system for use in the United States.

Mark Humayun, who holds joint appointments at the Keck School of Medicine of USC and the USC Viterbi School of Engineering, was a key member of the team that developed the device, which will be available to qualified patients at the Keck Medical Center of USC.

The Argus II, which received a unanimous recommendation for approval by the FDA’s Ophthalmic Devices Advisory Panel in September, restores some visual capabilities for patients whose blindness is caused by Retinitis Pigmentosa (RP), an inherited retinal degenerative disease that affects about 100,000 people nationwide.

“It is incredibly exciting to have FDA approval to begin implanting the Argus II and provide some restoration of vision to patients blinded from RP,” said Humayun, Cornelius Pings Professor of Biomedical Sciences and professor of ophthalmology, biomedical engineering, cell and neurobiology at USC. “In the patients that have been implanted to date, the improvement in the quality of life has been invaluable.

“The fact that many patients can use the Argus implant in their activities of daily living, such as recognizing large letters, locating the position of objects and more, has been beyond our wildest dreams,” Humayun added, “yet the promise to the patients is real, and we expect it only to improve over time.”

The Argus II, which is manufactured by Sylmar, Calif.-based Second Sight, was approved for use in Europe in 2011 and has been implanted in 30 patients in a clinical trial that began in 2007. Humayun performed many of the surgeries to implant the device.

The FDA approval paves the way for Second Sight to build a surgical network in the United States to implant the device, as well as to recruit hospitals to offer it, according to Robert Greensburg, president and CEO of the company.

The Argus II system uses a camera mounted on special glasses that sends a signal to an electronic receiver with 60 electrodes implanted inside the eye.

The receiver sends signals to the retina that travel through the optic nerve to the brain, where they can be interpreted as a visual picture. The researchers hope that one day the device can be improved to also help individuals with age-related macular degeneration, a similar but far more common disease.

Public inquiries regarding the Argus II can be directed to the Second Sight public information line at (855) 756-3703.

As the Argus II retinal implant is refined, it will be housed in the USC Institute of Biomedical Therapeutics. The new $60 million endowed interdisciplinary institute will bring together scientists, engineers and clinicians from around the world to study neural networks to develop bioelectronic solutions for the millions of people impacted by traumatic brain injury, stroke and debilitating eye diseases.

A bionic eye has given an Australian woman partial sight and researchers say it is an important step towards eventually helping visually impaired people get around independently.

Dianne Ashworth, who has severe vision loss due to the inherited condition retinitis pigmentosa, was fitted with a prototype bionic eye in May at the Royal Victorian Eye and Ear Hospital.

"It was really funny when it switched on I was waiting, waiting … I had these goggles on and I didn’t know what to expect, and I don’t know if anyone did know what I was going to see … Then all of a sudden I went ‘yep’ I could see a little flash and it was like a little, I suppose, a splinter … There were different shapes and dark black, lines of dark black and white lines together … Then that turned into splotches of black with white around them and cloud-like images … I can remember when the first bigger image came I just went ‘Wow,’ because I just didn’t expect it at all but it was amazing," she said.

The bionic eye, designed, built and tested by the Bionic Vision Australia, a consortium of researchers partially funded by the Australian government, is equipped with 24 electrodes with a small wire that extends from the back of the eye to a receptor attached behind the ear.