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Published - Tuesday, May 13, 2008

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LASIK: FDA hears warnings of risks, but local doctors say they aren't seeing major complications


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Testimony before the Food and Drug Administration last month reinforced warnings that LASIK surgery to correct vision comes with risks: lost vision, painful dry eye, glare and other night-vision problems.

Serious complications appear rare, affecting 1 percent or fewer cases, and the FDA estimates only 5 percent of patients aren’t satisfied with the outcome.
La Crosse eye surgeons say they are not seeing major complications from LASIK surgery because they say they carefully select patients and use the latest lasers and technology.

“With the modern technology and newer lasers today, there are few side effects, and the ones we had with the old technology such as glare and halos have gone away,” said Dr. Christopher Born, a Gundersen Lutheran ophthalmologist.

“The safety is far superior than 10 years ago, and I just don’t see the complications,” he said. “I’ve done LASIK on two of my three kids, and the other one is waiting.”

With LASIK, doctors peel back a flap in the cornea’s surface and zap the underlying layer to reshape the cornea and ease either nearsightedness or farsightedness. The newest version, considered safer, makes ultra-thin flaps using a second laser instead of a disposable blade.

Dr. Robert Freedland, a Franciscan Skemp ophthalmologist, said he just completed his 2,000th LASIK surgery and he hasn’t see major complications.

“We do see a lot of common problems such as dry eyes, but I see no one being debilitated by these problems,” Freedland said.

He said the accuracy and quality of treatment are better with the new lasers.

“We’re moving toward individualized treatment,” Freedland said. “Ten years ago the laser couldn’t see the patient — it was blind. Now the laser recognizes the individual patient. It reduces problems.”

Dr. Matt Runde, a Gundersen Lutheran ophthalmologist, said Gundersen Lutheran has invested in the Intralase laser for making flaps. The laser is safer, more accurate and has superior outcomes compared with previous lasers.

Runde said more than 90 percent of the refractive surgery at Gundersen Lutheran is LASIK — about 7,000 procedures in 10 years.

“The proven track record speaks for itself,” Runde said. “The rapid visual recovery and favorably safety profile, combined with the broadest range of FDA-approved treatments, make it the dominant procedure across the country.”

Born said about one-fourth of patients are turned down for LASIK because they are too nearsighted, their corneas are too thin or they have an unusually-shaped corneas.

But nationally it’s not clear just how many patients get screened appropriately, and some forge ahead anyway.

“Some patients are just not a cornea laser eye surgery patient,’’ stressed Dr. Kerry Solomon of the Medical University of South Carolina, a spokesman for the American Society for Cataract and Refractive Surgery. “There are still other options for them. ... And some are, quite frankly, better suited to staying with their glasses and contacts.”

Aggressive marketing makes patients falsely believe clear sight is guaranteed, said Dr. Jayne Weiss of Detroit’s Kresge Eye Institute, who chaired the FDA advisory panel.

Freedland said LASIK has become too commercialized and some patients shop around for the best price because insurance doesn’t pay for the procedure.

“We forget these operations have risks and benefits and are not commodities,” Freedland said. “We can’t think of LASIK like we’re purchasing a DVD player.

“I am concerned about patients traveling quite a distance to get a budget treatment,” he said. “They need to be close to their provider for care after surgery.”

Born said some doctors who only perform LASIK at a refractive eye surgery center may feel the pressure to increase the volume of patients. But he said LASIK makes up only 5 percent of the eye department business at Gundersen Lutheran.

“LASIK is not a major part of our business,” Born said. Mainly, we take care of eye diseases.”

Freedland said LASIK is safer than it ever has been, with 1 percent or less risk of complications.

“It’s a good operation with known risks, but we have a lot of happy people who function better,” Freedland said.

He said patients also need to have realistic expectations.

“The goal is to reduce a patient’s need for glasses, but there is no guarantee you can throw those glasses away in the garbage,” Freedland said. “We try to find the best treatment that fits the patient and do what’s right for the patient.”

The Associated Press contributed to this story.
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