Less invasive eye surgery approved
Radiofrequency waves OK'd for use
WASHINGTON -- The government has approved a new surgical device to treat farsightedness that uses radiofrequency waves, instead of a laser, to zap the cornea into shape.
The new "conductive keratoplasty," or CK, is a little less invasive than today's laser surgery.
Farsightedness is the inability to see clearly at close distances, such as while reading. To correct it, doctors plump up a flattened cornea, using the popular LASIK surgery or a similar method that uses a laser to heat the edge of the cornea.
Refractec Inc. says its CK system causes fewer side effects. Heat-causing radiofrequency waves pass through a tiny probe as thin as a human hair that doctors guide in a circle around the edge of the cornea.
The Food and Drug Administration approved the CK equipment last week, the Irvine, Calif., company announced last week.
In one study, 56 percent of treated eyes had 20/20 vision or better without glasses a year after surgery.
But the FDA cautioned that CK offers temporary vision correction, because vision can deteriorate for at least a year after surgery.
Some visual regression is expected after any farsightedness correction, but LASIK patients' vision typically stabilizes between three and six months post-treatment, said FDA ophthalmic device chief Dr. Everette Beers. CK patients' vision doesn't stabilize then -- and between six and 12 months post-surgery, they lose, on average, another 11 percent of vision, he said.
"It gives patients another option," Beers said. But "there is regression with this. ... Some people may have a little bit, others may have more."
There is no data showing whether retreatment is safe or works, he added.
The surgery will cost patients $1,500 to $2,000 per eye, about the same as LASIK, Refractec said. Doctors can buy the CK system for $48,500.