[Nfbf-l] Another Article: U.S. approves first method to give the blind limited vision. inspired by cochlear implants

[Alan Dicey]

U.S. approves first method to give the blind limited vision.
By PAM BELLUCK. Published: February 14, 2013.
The Food and Drug Administration on Thursday approved the first treatment to 
give limited vision to people who are blind, involving a technology called 
the "artificial retina."
With it, people with certain types of blindness can detect crosswalks on the 
street, burners on a stove, the presence of people or cars, and sometimes 
even oversized numbers or letters.

The artificial retina is a sheet of electrodes surgically implanted in the 
eye.
The patient is also outfitted with a pair of glasses with an attached camera 
and a portable video processor. These elements together allow visual signals 
to bypass the damaged portion of the retina and be transmitted to the brain.
The F.D.A. approval covers this integrated system, which the manufacturer 
calls Argus II.

The approval marks the first milestone in a new frontier in vision research, 
a field in which scientists are making strides with gene therapy, 
optogenetics, stem cells and other strategies.

"This is just the beginning," said Grace Shen, director of the retinal 
diseases program at the National Eye Institute, which helped finance the 
artificial retina research and is supporting many other blindness therapy 
projects. "We have a lot of exciting things sitting in the wings, multiple 
approaches being developed now to address this."

With the artificial retina or retinal prosthesis, a blind person cannot see 
in the conventional sense, but can identify outlines and boundaries of 
objects, especially when there is contrast between light and dark - 
fireworks against a night sky or black socks mixed with white ones in the 
laundry.

"Without the system, I wouldn't be able to see anything at all, and if you 
were in front of me and you moved left and right, I'm not going to realize 
any of this," said Elias Konstantopolous, 74, a retired electrician in 
Baltimore, one of about 50 Americans and Europeans who have been using the 
device in clinical trials for several years. He said it helps him 
differentiate curbs from asphalt roads, and detect contours, but not 
details, of cars, trees and people.
"When you don't have nothing, this is something. It's a lot."

The F.D.A. approved Argus II, made by Second Sight Medical Products, to 
treat people with severe retinitis pigmentosa, a group of inherited diseases 
in which photoreceptor cells, which take in light, deteriorate.

The first version of the implant had a sheet of 16 electrodes, but the 
current version has 60. A tiny camera mounted on eyeglasses captures images, 
and the video processor, worn on a belt, translates those images into 
pixelized patterns of light and dark. The processor transmits those signals 
to the electrodes, which send them along the optic nerve to the brain.

About 100,000 Americans have retinitis pigmentosa, but initially between 
10,000
and 15,000 will likely qualify for the Argus II, according to the company.
The F.D.A. says that up to 4,000 people a year can be treated with the 
device.
That number represents people who are older than 25, who once had useful 
vision, have evidence of an intact inner retinal layer, have at best very 
limited light perception in the retina, and are so visually impaired that 
the device would prove an improvement. Second Sight will begin making Argus 
II available later this year.

But experts said the technology holds promise for other people who are 
blind, especially those with advanced age-related macular degeneration, the 
major  cause of vision loss in older people, affecting about two million 
Americans. About 50,000 of them are currently severely impaired enough that 
the artificial  retina would be helpful, said Dr. Robert Greenberg, Second 
Sight's president and chief executive.

In Europe, Argus II received approval in 2011 to treat a broader group of 
people, those with severe blindness caused by any type of outer retinal 
degeneration, not just retinitis pigmentosa, although it is currently only 
marketed in Europe for that condition. In the U.S., additional clinical 
trials need to be completed before the company can seek broader FDA 
approval.

Eventually, Dr. Greenberg said, the plan is to implant electrodes not in the 
eye, but directly into the brain's visual cortex. "That would allow us to 
address blindness from all causes," he said.

Initially, the artificial retina will be available at seven hospitals in 
five states: New York, California, Texas, Maryland and Pennsylvania. It will 
cost about $150,000, not including the surgery and training sessions to use 
the device. Second Sight said it was optimistic that insurance would cover 
it.

Developed over 20 years by Dr. Mark S. Humayun, an ophthalmologist and 
biomedical engineer at the University of Southern California's Doheny 
Retinal Institute, the artificial retina was inspired by cochlear implants 
for the deaf.
Some financing came from a cochlear implant maker and other private sources, 
but about $100 million was provided by the National Eye Institute, the 
National Science Foundation and the Department of Energy, all federal 
agencies.

Dr. Humayun said he envisioned applying the technology to other conditions 
than blindness, implanting electrodes in other parts of the body to address 
bladder control problems, perhaps, or spinal paralysis.

"We don't think of the human body as an electrical grid, but it runs off 
electrical impulses," he said.

The Argus II has had relatively few safety problems, mostly post-surgical 
infections and occasional erosions of a thin layer in the eye that covered 
the implant. Those problems have been addressed, Dr. Greenberg said, and 
only two people needed to have the implant removed. An F.D.A. advisory panel 
voted unanimously last September to recommend approval, finding that 
benefits outweighed the risks.

Some patients experience more improvement than others, for reasons the 
company has not been able to determine. Kathy Blake of Fountain Valley, 
Calif., said she has had success with a Second Sight exercise to see if 
patients can identify large numbers or letters on a computer screen.

Dean Lloyd, a lawyer in Palo Alto, Calif., said he initially wondered, "Is 
it really worth all the time and expense? I, at first, did not think so." 
Early on, only nine electrodes were working, but over time his implant was 
adjusted so more electrodes responded, and now 52 of them work. He can see 
flashes of color, something not every patient can, and he wears the glasses 
and video processor constantly.

"If I don't wear it, it's like I don't have my pants on," he said. "I've 
even fallen asleep with the blooming thing."

Stephen Rose, the chief research officer for the Foundation Fighting 
Blindness, which supported Dr. Humayun's very early work but has not 
financed it since, said the artificial retina would eventually be only one 
of the options to help blind people.

"I think there are tremendous possibilities," he said. "I'm not downplaying 
the retinal prosthesis, don't get me wrong. It's huge for some individuals, 
and it's here now."

Barbara Campbell, 59, relishes how the device helps her navigate Manhattan 
streets, locate her Upper East Side bus stop, and spot her apartment 
building's foyer light while riding in a taxi.
Most exciting, though, is how it enhances her experience of museums, theater 
and concerts.
At a performance by Rod Stewart, "I could definitely see his hair," she 
said, which was white-blond under the lights. At a concert by Diana Ross, 
even though Ms. Campbell sat far away from the stage, she said Ms. Ross "was 
wearing a sparkly outfit, and I could see her."

No such luck at a performance by James Taylor, though. His low-key clothing 
created no contrast for the artificial retina to register. Alas, Ms. 
Campbell said, "He wasn't so sparkly."

Source URL:
http://www.nytimes.com/2013/02/15/health/fda-approves-technology-to-give-limited-vision-to-blind-people.html?pagewanted=all

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