VisionCare's eye telescope wins approval

By Steve Johnson

sjohnson@mercurynews.com

Posted: 07/06/2010 09:16:55 PM PDT
Updated: 07/07/2010 08:32:51 AM PDT

In a decision cheered by advocates for the visually impaired, federal regulators Tuesday approved a Saratoga company's first-of-a-kind implantable eye telescope for elderly people with an advanced form of age-related macular degeneration.

The device made by VisionCare Ophthalmic Technologies is aimed at about 750,000 people in the United States who have the most severe and untreatable form of the disease, which causes a blind spot in the center of their vision.

"This innovation has the potential to provide many people with an improved quality of life," said Dr. Jeffrey Shuren, director of the Center for Devices and Radiological Health at the U.S. Food and Drug Administration, which approved VisionCare's device.

Getting the FDA's approval is a big moment for privately held VisionCare, which has been developing the telescope for more than a decade. In 2006, an FDA advisory panel recommended the telescope not be approved because of concerns about its usefulness and safety. But after VisionCare did more studies, the panel unanimously gave the device its blessing.

Although VisionCare has raised $59 million since it was founded in 1997, it has no other products on the market and has consistently lost money. Now the company is planning to roughly double its work force of 23, and "we hope to turn a profit after we launch the product," said Chet Kumar, VisionCare's

vice president for business and market development.

Even though most of the approximately 8 million people suffering from the disease in this country won't qualify to be treated with the device, advocates for patients suffering from the ailment hailed the FDA's approval.

"It's very exciting," said Dan Roberts, founding director of Macular Degeneration Support, a group he founded after he was diagnosed with the illness. "The product needs to be given a chance — anything that is going to give the patients better sight until we have a cure, anything that's going to give hope."

Dziem Nguyen, a supervisor at the Santa Clara Valley Blind Center, also was enthusiastic.

Noting that most of the center's patients suffer from age-related macular degeneration, she called the FDA's action "really good news to our folks here."

The ailment, which primarily afflicts the elderly, damages the center of the retina — or macula — which is the light-sensitive tissue at the back of the eye. The result is deteriorated sight in the center of the visual field, causing blurriness and eventually an inability to recognize faces, read or watch television.

The FDA limited VisionCare's telescope to people 75 or older, whose disease has progressed to a severe state. The device — which is about the size of a pea — is implanted in an outpatient procedure behind the colored portion of the eye known as the iris after the patient's own lens is removed.

By magnifying vision by 2.2 times to 2.7 times, depending on which model is used, the device projects visual images away from the damaged macula and onto the surrounding healthy retinal tissue. It is placed in only one eye, since the patient's other eye is needed for peripheral vision.

In a study involving more than 200 patients implanted with the device, the FDA said, 75 percent "improved their level of vision from severe or profound impairment to moderate impairment."

Although the device is approved for people with advanced wet or dry age-related macular degeneration, patients need to consult with a specialist and be tested to determine whether they are good candidates for the surgery.

In some cases, the implantation can distort the cornea's clarity, the FDA said. As a result, the federal agency is requiring VisionCare to conduct follow-up studies on patents outfitted with the telescope.

Kumar said the company has not set a price for the device because that will depend on how much Medicare will agree to cover. When those details are worked out over the next couple of months, patients can start getting implanted with the telescope, he said, noting that details about when the device will be available will be posted on www.centrasight.com.

What Big Eyes You Have, Dear, but Are Those Contacts Risky?

From the New York Times.
By CATHERINE SAINT LOUIS
Published: July 3, 2010

Of all the strange outfits and accessories Lady Gaga wore in her “Bad Romance” video, who would have guessed that the look that would catch fire would be the huge anime-style eyes she flashed in the bathtub?

Lady Gaga’s wider-than-life eyes were most likely generated by a computer, but teenagers and young women nationwide have been copying them with special contact lenses imported from Asia. Known as circle lenses, these are colored contacts — sometimes in weird shades like violet and pink — that make the eyes appear larger because they cover not just the iris, as normal lenses do, but also part of the whites.

“I’ve noticed a lot of girls in my town have started to wear them a lot,” said Melody Vue, a 16-year-old in Morganton, N.C., who owns 22 pairs and wears them regularly. She said her friends tended to wear circle lenses for their Facebook photos.

These lenses might be just another beauty fad if not for the facts that they are contraband and that eye doctors express grave concern over them. It is illegal in the United States to sell any contact lenses — corrective or cosmetic — without a prescription, and no major maker of contact lenses in the United States currently sells circle lenses.
Yet the lenses are widely available online, typically for $20 to $30 a pair, both in prescription strengths and purely decorative. On message boards and in YouTube videos, young women and teenage girls have been spreading the word about where to buy them.

The lenses give wearers a childlike, doe-eyed appearance. The look is characteristic of Japanese anime and is also popular in Korea. Fame-seekers there called “ulzzang girls” post cute but sexy head shots of themselves online, nearly always wearing circle lenses to accentuate their eyes. (“Ulzzang” means “best face” in Korean, but it is also shorthand for “pretty.”)

Now that circle lenses have gone mainstream in Japan, Singapore and South Korea, they are turning up in American high schools and on college campuses. “In the past year, there’s been a sharp increase in interest here in the U.S.,” said Joyce Kim, a founder of Soompi.com, an Asian pop fan site with a forum devoted to circle lenses. “Once early adopters have adequately posted about it, discussed it and reviewed them, it’s now available to everyone.”

Ms. Kim, who lives in San Francisco and is 31, said that some friends her age wear circle lenses almost every day. “It’s like wearing mascara or eyeliner,” she said.

Sites that sell contact lenses approved by the Food and Drug Administration are supposed to verify customers’ prescriptions with their eye doctors. By contrast, circle lens Web sites allow customers to choose the strength of their lenses as freely as their color.

Kristin Rowland, a college senior from Shirley, N.Y., has several pairs of circle lenses, including purple ones that are prescription strength and lime green ones that she wears behind her glasses. Without them, she said, her eyes look “really tiny”; the lenses “make them look like they exist.”

Ms. Rowland has a part-time job at a Waldbaum’s supermarket, where customers sometimes tell her, “Your eyes look huge today,” she said. Even her manager expressed curiosity, asking, “Where did you get those things?” she said.
Karen Riley, a spokeswoman for the F.D.A., was a bit surprised, too. When first contacted last month, she did not know what circle lenses were or the extent to which they had caught on. Soon after, she wrote in an e-mail message, “Consumers risk significant eye injuries — even blindness” when they buy contact lenses without a valid prescription or help from an eye professional.

Dr. S. Barry Eiden, an optometrist in Deerfield, Ill., who is chairman of the contact lens and cornea section of the American Optometric Association, said that people selling circle lenses online “are encouraging the avoidance of professional care.” He warned that ill-fitting contact lenses could deprive the eye of oxygen and cause serious vision problems.

Nina Nguyen, a 19-year-old Rutgers student from Bridgewater, N.J., said she was wary at first. “Our eyes are precious,” she said. “I wasn’t going to put any type of thing in my eyes.”

But after she saw how many students at Rutgers had circle lenses — and the groundswell of users online — she relented. Now she describes herself as “a circle lens addict.”

“What made me comfortable is so many girls out there wearing them,” Ms. Nguyen said.

A makeup artist named Michelle Phan introduced many Americans to circle lenses through a video tutorial on YouTube, where she demonstrates how to get “crazy, googly Lady Gaga eyes.” Ms. Phan’s video, called “Lady Gaga Bad Romance Look,” has been viewed more than 9.4 million times.
“In Asia, it’s all about the eyes in makeup,” said Ms. Phan, a Vietnamese-American blogger who is now Lancôme’s first video makeup artist. “They like the whole innocent doll-like look, almost like anime.”

These days girls of many races are embracing the look. “Circle lenses are not just for Asian people,” said Crystal Ezeoke, 17, a second-generation Nigerian from Lewisville, Tex. In videos she posts to YouTube, Ms. Ezeoke’s gray lenses make her eyes look an otherworldly blue.

At Lenscircle.com, which is based in Toronto, most of the customers are Americans, ages 15 to 25, who heard about circle lenses through YouTube reviewers, said Alfred Wong, 25, the site’s founder. “A lot of people like the dolly-eyed look, because it’s cute,” he said. “It’s still an emerging trend” in America, he added, but “it’s getting more and more popular.”

Jason Aw, an owner of PinkyParadise.com, a site based in Malaysia, is well aware that his shipments to the United States are illegal. But he is convinced that his circle lenses are “safe; that is why a lot of customers will recommend” them to others.

His “job,” he wrote in an e-mail message, is “to provide a platform” for people who want to buy the lenses but cannot do so locally.

Girls like Ms. Vue, the 16-year-old in North Carolina, help steer customers to sites where circle lenses are sold. She has posted 13 reviews of circle lenses on YouTube, enough to merit her a coupon code at tokioshine.com, which gives her viewers 10 percent off. “I have been getting tons of messages asking where to get circle lenses, so this is finally a legitimate answer for you,” she said in a recent video.

Ms. Vue was 14 when she begged her parents to get her first pair, she said. These days, however, she is having second thoughts about them — but not for health or safety reasons.

Circle lenses have just grown too popular, Ms. Vue said. “It kind of makes me not want to wear them anymore, because everyone is wearing them,” she said.

Study: The secret to long life is having the right genes

By Elizabeth Weise, USA TODAY

People who live to 100 and beyond have a unique set of genetic variations that seems to help them live 20 years longer than the rest of the population, researchers have found.
The gene clusters seem to trump disease-causing genes that would otherwise cause common problems of aging. Winning this genetic lottery, though, is no free pass: Exercise and healthy living still play a big role, scientists say.

The paper, in Thursday's online version of the journal Science, describes how scientists scanned the genomes of more than 1,000 centenarians, all Caucasians, from the New England Centenarian Study and found a cluster of 150 genetic markers that are highly predictive of extreme long life.

The older a subject got, the "stronger and stronger the correlation," says Thomas Perls, a professor of medicine at the Boston University School of Medicine and senior author on the paper.

Scientists have always known that long life runs in families, but this is the first time they have had proof that it's a genetic trait. Looking at his or her genes, "we can predict with about 77% accuracy" the probability of a person living to 100, Perls says.

There isn't a publicly available genetic test for this cluster of genes, though Perls says someone probably will start selling one soon. A good surrogate is to look at how long people in your family live.

Genes clearly don't tell the whole story: 23% of those who lived to be 100 or older didn't have the particular set of variants, the researcher found.

What they also don't yet know is what the genes actually are doing to make people live longer.

The study found that centenarians can be divided into 19 different groups of "genetic signatures" that correlate with different patterns of exceptional longevity. "Some signatures correlate with longer survival, others with the most delayed onset of age-related disease such as dementia ... or hypertension," says Paola Sebastiani, a biostatistician at Boston University and lead author on the paper.

The good news, Perls says, is that most humans have genetic variations "to allow us to get to 88, which is eight years longer than average." The catch: To achieve that age, he says, you still have to live a healthy life — exercise, avoid obesity, don't smoke, don't drink too much.

Study: The secret to long life is having the right genes

By Elizabeth Weise, USA TODAY

People who live to 100 and beyond have a unique set of genetic variations that seems to help them live 20 years longer than the rest of the population, researchers have found.
The gene clusters seem to trump disease-causing genes that would otherwise cause common problems of aging. Winning this genetic lottery, though, is no free pass: Exercise and healthy living still play a big role, scientists say.

The paper, in Thursday's online version of the journal Science, describes how scientists scanned the genomes of more than 1,000 centenarians, all Caucasians, from the New England Centenarian Study and found a cluster of 150 genetic markers that are highly predictive of extreme long life.

The older a subject got, the "stronger and stronger the correlation," says Thomas Perls, a professor of medicine at the Boston University School of Medicine and senior author on the paper.

Scientists have always known that long life runs in families, but this is the first time they have had proof that it's a genetic trait. Looking at his or her genes, "we can predict with about 77% accuracy" the probability of a person living to 100, Perls says.

There isn't a publicly available genetic test for this cluster of genes, though Perls says someone probably will start selling one soon. A good surrogate is to look at how long people in your family live.

Genes clearly don't tell the whole story: 23% of those who lived to be 100 or older didn't have the particular set of variants, the researcher found.

What they also don't yet know is what the genes actually are doing to make people live longer.

The study found that centenarians can be divided into 19 different groups of "genetic signatures" that correlate with different patterns of exceptional longevity. "Some signatures correlate with longer survival, others with the most delayed onset of age-related disease such as dementia ... or hypertension," says Paola Sebastiani, a biostatistician at Boston University and lead author on the paper.

The good news, Perls says, is that most humans have genetic variations "to allow us to get to 88, which is eight years longer than average." The catch: To achieve that age, he says, you still have to live a healthy life — exercise, avoid obesity, don't smoke, don't drink too much.