DURHAM, N.C. (Ivanhoe Newswire) – Larry and Jerry Hester’s love story spans more than four decades. But just after their ten year anniversary, a genetic disorder known as retinitis pigmentosa robbed Larry of his sight.
“If my sight was ever completely restored, the very first thing I would want to do would be to see my wife,” Hester told Ivanhoe.
Hester’s now closer to that reality: he’s a candidate for a new bionic eye at Duke University Hospital.
“We can for the first time restore vision that was once considered to be permanently lost,” Paul Hahn, MD, PhD, Retinal Ophthalmologist at Duke Eye Center, told Ivanhoe.
A miniature video camera picks up images that are sent to a micro-processor and wirelessly transmitted to a computer chip in the eye.
“It stimulates a part of the retina that’s still healthy, and provides flashes of light which the patient can interpret as an image,” Dr. Hahn said. “So they’re not going to see the way you or I see.”
Patients have to learn to see in a new way. Hester will see high contrast items of light and dark and identify movement. And maybe will even be able to see his grandchildren for the first time.
“Words really can’t express how exciting it is and how thrilling it is,” Hester said.
The bionic eye known as the Argus II is now being offered in 13 sites around the country and is currently only approved for those with retinitis pigmentosa. But in the future, it could help restore other forms of blindness.
The gift of sight comes with a price tag of about 145,000 dollars. But nationally, Medicare has approved reimbursement.
BACKGROUND: Retinitis pigmentosa (RP) is an eye disease in which there is damage to the retina. The retina is the layer of tissue at the back of the inner eye. It converts light images to nerve signals, and then sends those signals back to the brain. This can cause decreased vision at night or in low light, loss of peripheral vision, and loss of central vision. Retinitis pigmentosa affects one in 4,000 people in the United States. Retinitis pigmentosa can run in families. The cells controlling night vision are most likely to be affected. However, in some cases, retinal cone cells are damaged the most. The main sign of the disease is the presence of dark deposits in the retina. (Source: http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0002024/)
SYMPTOMS: Symptoms usually start during young adulthood, although RP may be seen at any age and include night blindness and loss of peripheral vision. Symptoms may not necessarily mean you have the disease, but if you experience one or more, you should contact your eye doctor for a complete eye exam. (Source: http://www.kellogg.umich.edu/patientcare/conditions/pigmentosa.html)
TREATMENT: There are currently very few treatments available for RP. Sometimes, the degeneration can be slowed to preserve vision for a longer time. Genetic studies of RP are a significant factor in finding a cure or prevention for this disease. (Source: http://www.kellogg.umich.edu/patientcare/conditions/pigmentosa.html)
NEW TECHNOLOGY: The bionic eye, also known as the Argus II system, can restore vision that was once considered permanently lost. The retinal implant restores visual impulses. The FDA approved the device in 2013 for use in adults 25 years or older. It does not restore normal 20-20 vision, but a patient with the device may be able to follow the lines of a crosswalk or sort laundry. After the implant surgery the patient wears glasses with an attached camera and a portable video processor. The video camera inside the patient's glasses captures a scene. The video is then sent to the computer, where it is processed and transformed into instructions that are sent back to the glasses. The instructions are transmitted wirelessly to an electrode array implanted on the retinal surface. Small pulses of electricity are emitted. These pulses bypass the damaged photo receptors and stimulate the retina's remaining healthy cells. The visual information is transmitted along the optic nerve to the brain. This creates the perception of light. Patients can learn to interpret these visual patterns with their retinal implant. The chip has 60 pixels; so when stimulated the patient can see flashes of light of high contrast items, certain colors, large letters and they can sort objects. The bionic eye is intended for patients with severe to profound RP. (Source: Duke University)
Paul Hahn, M.D., Ph.D., Assistant Professor of Ophthalmology in the Division of Vitreoretinal Surgery and Diseases at the Duke Eye Center, talks about a new bionic eye.
Can you tell us a little bit about the bionic eye’s background?
Dr. Hahn: We’re talking about the Argus-2 Retinal Prosthesis, otherwise known as the bionic eye. So Dr. Mark Humayun, who is currently at the University of Southern California, 20 years ago did his residency at the Duke Eye Center and started thinking of this device. And 20 years later it’s finally come to fruition. We’re very excited that this is something that we can finally implant into humans.
Is this only for folks with retinitis pigmentosa then or can this be used by other people that are blind for other reasons?
Dr. Hahn: Currently, it’s only FDA approved for patients with retinitis pigmentosa and for patients with profound vision loss to the level of what we call light perception from retinitis pigmentosa. However, it is a device which is designed to target other diseases and certainly as we get more experience with the device, as we see how it does in retinitis pigmentosa, then we’ll look for other applications.
Can you tell us a little bit about retinitis pigmentosa?
Dr. Hahn: Retinitis pigmentosa is a relatively rare disease. It affects about 1 in 3,000 Americans which means that about 100,000 Americans in the country. Of the patients with retinitis pigmentosa, about 10,000 of those Americans are believed to be eligible for this device. Retinitis pigmentosa is a genetic disease and it causes slow but progressive degeneration of the retina which is like the film of the eye. So because of that damage to the retina, the eye is no longer able to see and this generally occurs over an extended period of time, perhaps about 20 years, leading from normal vision to near total blindness.
Can you just talk a little bit more about how the system exactly works?
Dr. Hahn: The patient wears these glasses and in the middle of the glasses there is a small camera. The camera will pick up whatever it is that the patient is looking at. That signal is then sent to this little computer that is worn either on the patient’s belt or around their shoulder or in their pocketbook or wherever they choose to place it. That signal is then sent by this coil here wirelessly to an implant that is placed around the eye; that wirelessly sends that signal which then stimulates the retina and provides flashes of light which the patient can interpret as an image.
So are they seeing the same thing that we would see or are they seeing things in a different manner?
Dr. Hahn: One of the most important things for patients to understand is that this device does not restore normal vision. What this device does is it provides series of flashes that the patient can interpret as an image. So after implantation of this device, patients should not expect to be able to read, to be able to drive, or not even to recognize faces, but what they can expect to do is identify high contrast items. For example, the opening of a doorway, or straight lines in a crosswalk that allows them to function more independently than they previously did.
It’s not even like someone who has really poor vision though, it’s completely different?
Dr. Hahn: Totally different. So this is very similar in technology to the cochlear implant which restores hearing to patients who are deaf. And patients who receive that cochlear implant report having to essentially learn a new language. And when patients receive this type of bionic eye, they really have to relearn how to see. So they’re not going to see the way you or I see. And I think for people with normal or near normal vision, it’s very difficult to understand what the level of vision is that these profoundly blind patients have. Patients with that level of vision are unable to function independently. They often have associated mental conditions, like depression, or loss of independence. And for them to get even a little bit of visual stimulus back, actually improves their level of functioning quite a bit.
Is it covered by insurance? Or what’s the cost of this?
Dr. Hahn: So the device itself is quite expensive. It’s estimated to run about $145,000. Currently Medicare has approved at the national level reimbursement for this device which is great news. We are currently working out these final insurance hurdles so we can start to implant this device. Implantation will require identification of patients who are eligible. These patients are typically patients who have not been regularly seen by an eye doctor perhaps because up until now, there has been literally no treatment for them. Once we identify these patients, we will surgically implant this device, which will approximately take anywhere from 3 to 4 hours. Following that, there is about a month where the patient learns to use the device, and the device is programmed. Those stimuli are programmed to correspond to something that the patient can understand and for the next 5 or 6 months after that, the patient undergoes rehabilitation and occupational therapy to learn how to function in their daily activities with this device.
This was FDA approved at the beginning of last year, but it’s now really just starting to take off?
Dr. Hahn: This device was FDA approved in February of 2013, but the device itself wasn’t quite available. So over the past year the device has become available and we’re finally working out insurance hurdles and I expect the first device to be implanted in the very near future.
How big of a breakthrough would you say this is for the medical community?
Dr. Hahn: I think for the ophthalmology community and really the medical community at large, this is a revolutionary device. This marks the first time, I believe, where rather than stabilizing vision loss, or trying to prevent patients from further losing vision, we can restore vision that was once considered to permanently lost. So in my mind, this is truly remarkable and revolutionary.
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