Nearsightedness.
Posted on 09/13/2004 2:14:07 PM PDT by happygrl
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 Monday by the Food and Drug Administration (news - web sites).
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 (news - web sites) 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.
Just curious.
What is Myopia?
Do they make 'em for Democrats?
Nearsightedness.
Nearsightedness.
Nearsightedness.
I'm sorry, I cannot read your question. Would you please use a larger font?
FWIW, I can say the implants they use for cataracts open up a whole new world. It's really amazing.
Thanx.
Well, this is probably what I'll want to do in a couple of years. I have EXTREME nearsightedness, got glasses when I was 2 and contacts when I was 9 (in 1977). I'm grateful to God that I'm able to see with corrected vision. I was tempted to do Lasik, except that the people most at risk for Lasik failure are those with the worst vision.
My eye doctor brought this lens-implant thing up to me last year. He and I agreed that, since I'm comfortable with corrected vision, that we would wait and see on this lens implant approach.
I have almost the same thing, one in each eye, to replace my natural lenses after cataract surgery.
I DO NOT use glasses now, where I needed them for astigmatism before.
You can see them at
http://www.crystalens.com
I personally know someone who had this surgery performed on both eyes to correct for yellowing of the lens with age, and years of blurred vision. The procedure is usually performed one eye at a time to note any complications that might arise. After the first eye, she told me she couldn't wait for the other eye. When the second eye was performed she was so happy she went out to her greenhouse to look at her orchids that she'd never before had seen in all their beauty and had tears in her eyes for being given back the gift of vision. She said it was like "having the eyes of a little girl again". That was three years ago and there were no complications whatsoever.
Yes but only in "rose" color...
I had cataracts removed via phacoemulsification earlier this year. Ocular implants replaced both damaged lenses.
I no longer need glasses at all for distance. I was wearing "coke bottle" lenses with corrections of -8.50 left and -10.00 right.
I have reading glasses for close-up work.
A few awkward weeks between surgeries- they did them about a month apart.
100% satisfied!!
This surgery is different from cataracts surgery in that the natural lens is left in place and the artifical one
supplements it. There are different types of lens under study - some go in front of the natural lens, some behind. I'm sure we'll be seeing more lens being approved in the coming years.
I'm keeping an eye on this procedure (haha), as I'm very near-sighted and my corneas too thin for Lasik. Luckily I have decent vision with soft contacts, although I am nealy blind without them. I'm certainly hoping the price comes down - $4K per is a lot of coin.
It's where you can see only what is right in front of your nose. It's kind of the opposite of presbyopia where you cannot see what is right in front of your nose--like Dan Rather.
I'm blurred at all distances with my up close being the worst, my distance the best. Middle only a tad better, my reading distance is now at 400. I hate glasses. Vision just keeps getting worse as I age, they are hot, uncomfortable and always smudged. Had 1 cataract out and the other is only 15%. This surgery sounds promising.
Dunno - I had lasik and it took me from durn near legally blind to 20/15 in both eyes. Changed my life. But I had lots of extra corneal tissue to work with and not everyone does - those folks would probably profit from this. I wish these guys luck.
Ping
I just had my left eye done and the right eye next week (2 weeks between surgeries). It is a miracle! Had a check-up today and the left eye is 20/20. Dr. said the right eye should be the same. No more glasses, except for reading and they can be simple magnifying type. Been very myopic since birth and this is truly miraculous!
Being able to see is very empowering.
Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.