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Cheryl McConnell finally got so fed up with reading glasses last January that she had a brand-new procedure to correct her aging eyes. Now the 59-year-old from New Orleans brags that she can read just about anything.
''Newspaper print is easy,'' she says. She adds that her friends are jealous of her ability to read labels, the fine print and maps -- all without granny glasses.
Many more Americans probably will follow suit if studies on the procedure, conductive keratoplasty, or CK, continue to go well. CK already is approved for a condition called hyperopia, or farsightedness, in people over 40. Refractec Inc., which developed the procedure, announced today that it has asked the Food and Drug Administration to approve the procedure for people with presbyopia, or aging eyes.
Refractec expects to get the nod from the FDA in 2004. If so, the company could start marketing the procedure. Right now, most people with aging eyes wear reading glasses to read the newspaper, menus, price tags or even a golf scorecard.
An estimated 90 million Americans have presbyopia, a condition that strikes after age 40 and afflicts everyone to some degree by age 51. Presbyopia occurs when the cornea gets stiff. That flatter cornea leads to difficulty focusing on nearby objects.
The procedure developed by Refractec uses radio waves -- as opposed to a laser in the more common LASIK procedure -- to reshape the cornea. LASIK isn't approved for presbyopia.
The procedure costs $1,500 to $2,000. Insurance companies probably will not pay for CK because granny glasses work just fine to correct the problem.
In April 2002, the FDA approved CK for people who have hyperopia, which is caused by an eyeball that is too short or a cornea that is too flat.
That approval means eye doctors can offer CK to patients with aging eyes in what is called an off-label use. To get the FDA's approval for the treatment of aging eyes, the company will have to show that CK can safely treat presbyopia, says Daniel Durrie, a Kansas City eye surgeon who has conducted studies on CK.
In one study submitted to the FDA, for example, Durrie and other investigators studied 130 people with presbyopia who had received the CK procedure. The team found that although just 7% could read newspaper or magazine print without reading glasses beforehand, 69% could do so one year later.
The procedure is safe, says Marguerite McDonald, an eye surgeon at Tulane University in New Orleans who was involved in the study. The investigators found no instances of infection, scarring or other problems that could lead to vision problems. In some cases, people still needed glasses to read very small print.
But researchers simply don't know the complications that might crop up later, says ophthalmologist Peter Whitted of Midwest Eye Care in Omaha.
''This is a surgical operation, and like any surgery, it involves some risk,'' he says.
It appears that CK is safe, but there could be rare problems with the procedure that could surface as time goes on, says Whitted, who is a spokesman for Prevent Blindness America.
For example, any surgical procedure can introduce an infection, which if not controlled can lead to scarring, he says. He urges patients to talk to their eye doctor about such risks before they sign up for a procedure like CK.
And no one knows how long CK will last. If the cornea starts to flatten out again, people like McConnell might have to pay for a second operation two, five or 10 years after the first one -- and worry about the side effects all over again.
That doesn't mean patients shouldn't sign up for CK, he says. It just means that baby boomers and others who are looking for youthful eyesight ought to consider carefully the benefits as well as the risks.
The long-term risk, if any, didn't put off McConnell, who says she is thrilled with the results.
''I look back at pictures of myself and I just hate it,'' she says. ''Granny glasses make you look 10 years older.''
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