Fw: FDA approves implantable lenses

----- Original Message ----- 
From: "Leon Gilbert" <lwg@xxxxxxxxxxxxxxxx>
To: "Blind News Mailing List" <BlindNews@xxxxxxxxxxxxxxxxxxxx>
Sent: Monday, September 13, 2004 5:43 PM
Subject: FDA approves implantable lenses


> Sept. 13, 2004, 3:36PM
> FDA approves implantable lenses
> Associated Press
>
> WASHINGTON - There's a new option for people who suffer from extreme
nearsightedness, whose world loses its crisp edge just a
> few inches from their noses. The first implantable lens for
nearsightedness was approved today by the Food and Drug
> Administration.
>
> A surgeon slips the lens through a small incision and implants it in front
of the natural lens. Like a photographer swiveling
> a camera lens into focus, the tiny hard plastic lens works behind the
scenes to help the eye create in-focus images.
>
> An estimated 53 percent of Americans use contact lenses or eyeglasses to
correct their vision.
>
> The lens implant is designed to provide an alternative to glasses, contact
lenses or Lasik surgery for people who have
> trouble seeing distant objects. Already in use in Europe, the lens is
manufactured by Ophtec USA Inc., of Boca Raton, Fla.,
> under the trade name Artisan, which will be distributed by American
Medical Optics under the Verisyse brand name.
>
> The implanted lens "provides superior quality of vision, especially for
individuals with high myopia," said Rick McCarley,
> president and chief executive officer of Ophtec USA.
>
> The lens implant, which will cost $3,000 to $4,000 per eye, currently is
targeted at patients who, for various reasons, can't
> get Lasik, which costs an average of $1,785 per eye.
>
> McCarley said the lens implant typically is not covered by health
insurance because it is an elective procedure. "However,"
> he said, "we have had some cases ... where the patients' visual acuity, or
their level of myopia, was so bad that some
> insurance companies did work with them because it allowed a person who
previously could not work, it allowed them to work."
>
> "I think it's huge," said Robert K. Maloney, an ophthalmology associate
professor at the University of California-Los Angeles
> who has corrected the vision of such stars as Cindy Crawford and Kenny G
with Lasik. "It is huge in the same way Lasik was
> huge a decade ago."
>
> Maloney, who has performed experimental implant procedures on nearly 100
patients since 1997, said the implantable lens is 50
> percent more accurate than Lasik. "And it gives better quality of vision:
The vision is crisper, brighter and clearer," he
> said.
>
> After three years, 92 percent of 662 patients had 20/40 or better vision,
considered standard vision necessary to obtain a
> driver's license, and 44 percent had 20/20 or better, the FDA said, citing
Ophtec research. The implant was tested in people
> whose nearsightedness was moderate to severe.
>
> However, the FDA said the lens implant may not eliminate the need for
glasses for night driving or other activities performed
> in low light.
>
> Eric Donnenfeld, assistant clinical professor of ophthalmology at Cornell
University Medical College, said the most visually
> impaired patients would be eligible for the new procedure.
>
> "If you held your hand in front of their face, they could not count your
fingers," said Donnenfeld, who has performed 50
> procedures as part of the FDA clinical trial. "They are the most grateful
patients we see in our practice."
>
> Count Rosalia de Firmian of Santa Barbara, among the grateful. This
summer, Dr. Kerry Assil implanted a lens into her left
> eye. Within a few weeks, de Firmian will return to treat the right eye.
>
> Her vision began deteriorating when she was 6 years old. She's worn
corrective contact lenses for 40 years, losing her
> ability to see each night when she removes them.
>
> Now, when she wakes, the world she sees from one eye, at least, is clear.
>
> "This is new. This is something you cannot explain," she said. "I'm, like,
free. Free. I say, 'Wow, I can't believe it.' I'm
> still discovering, every day, marvelous things. ... I can see my shoes, my
slippers. Everything. I see the wall, the clock."
>
> For all of de Firmian's giddiness, however, others warn of the risk of
patients developing cataracts or eye-destroying
> infections.
>
> "Even though that is a very small risk ... that is significant," said
Balamurali Ambati, an ophthalmologist and corneal
> specialist at the Medical College of Georgia. "Anytime the eye is opened,
bacteria can get in."
>
> Nicholas Tarantino, vice president of global clinical research and
development for Advanced Medical Optics, said no patients
> in the U.S. clinical trials developed cataracts.
>
> The FDA is requiring the company to do a follow-up, five-year study of
users of the lens to determine any side effects.
>
> One possible concern, FDA said, is the loss of endothelial cells in the
corneas of patients who received the implants. These
> cells form a layer on the undersurface of the cornea and are essential to
keeping the cornea clear.
>
> In the tests, there was a steady loss of endothelial cells of 1.8 percent
a year. Officials said it is not known whether this
> loss will continue at the same rate, or what the long-term effect of this
device on the cornea's health might be. The FDA is
> requiring the lens label to specify it be used only in patients with a
dense enough layer of these cells to stand some loss
> over time.
>
>  Copyright HoustonChronicle.com 2004.
>
> http://www.chron.com/cs/CDA/ssistory.mpl/health/2793091
>
>
>
>
>
> --
> BlindNews mailing list
>
> Archived at: http://GeoffAndWen.com/blind/
> Address message to list by sending mail to: BlindNews@xxxxxxxxxxxxxxxxxxxx
>
> Access your subscription info at:
http://blindprogramming.com/mailman/listinfo/blindnews_blindprogramming.com



  ------------------------------------------------
- To post messages on SMCC mailing list, simply send email to
smcc@xxxxxxxxxxxxxx

- You can subscribe to SMCC mailing list by sending email to
smcc-request@xxxxxxxxxxxxx
with 'subscribe' in the Subject field with your subscriber list.

- You can unsubscribe from SMCC mailing list by sending email to
smcc-request@xxxxxxxxxxxxx
with 'unsubscribe' in the Subject field

This list is managed by Dang Hoai Phuc
Please click this link
http://dhp.p9.org.uk
to visit his own website!

Other related posts: