[Nfbf-l] U.S. Approves First Method to Give the Blind Limited Vision (New York Times)
Alan Dicey
adicey at bellsouth.net
Sat Feb 16 16:18:59 UTC 2013
Dear Friends,
This has been all over the Net, Television, and in lots of newspapers, but I
am sending this along as each article is a bit different, and such fantastic
news is of course worth reading over and over!
I am like you thrilled and must tell you, ever since I heard Ray Kurzweil's
lecture entitled: "The 64 squares on a Chess Board", many years ago, I knew
a "Tecnical Solution" would win the "Race" to find a Cure for Blindness!
With Best Regards,
Alan
Miami, Florida
- - -
U.S. Approves First Method to Give the Blind Limited Vision
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.”
Enlarge This Image
Béatrice de Géa for The New York Times
Dr. Lucian Del Priore, an ophthalmology surgeon at New York-Presbyterian
Hospital/Columbia University Medical Center, examines Barbara Campbell's eye
in 2009, after her retinal implant.
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.
Enlarge This Image
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.”
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