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MEDICINE / THE MD

Life with Lasik: a closer look

Millions have undergone the vision-correcting surgery. Now the FDA is studying its effect on daily living.

June 16, 2008|Valerie Ulene | Special to The Times

Throughout my life, I've been blessed with 20/20 vision -- until recently. In just the last several months, I've had to hold menus at arm's length to read them. I fall asleep after reading only three or four pages of a novel. I find myself squinting in an attempt to bring the world into focus. And I have to use a larger font on the computer -- and rely on my children to read fine print.

But I haven't been able to bring myself to get a pair of glasses.

Maybe it's the inconvenience or simply vanity that's been stopping me. But I've wanted to explore the possibility of a more permanent -- and less obtrusive -- solution, namely Lasik. A few minutes of discomfort seem a whole lot better than a lifetime with glasses or contact lens.

That may be true for many people, but the Food and Drug Administration would rather that I -- and others like me -- not rush into Lasik ill-informed. It's launched a study to examine what patients' lives are like after the surgery.

At first glance, almost everything written about Lasik makes the procedure seem like nothing short of a miracle. When the cornea's shape isn't just right, images appear distorted and blurry. Small adjustments make a big difference, and the procedure successfully treats nearsightedness, farsightedness and astigmatism-related blurriness with remarkable accuracy.

Lasik, or laser-assisted in situ keratomileusis, uses a laser to permanently change the shape of the cornea, the clear covering of the front of the eye. During the procedure, the physician first cuts a flap in the outermost layer of the cornea. The flap is folded back, revealing the cornea's deeper layers. A computer-controlled laser vaporizes a portion of these underlying tissues. Then the flap is closed.

Laser eye centers promise clear, sharp vision in minutes, and patients often rave about their results. But Lasik isn't right for everyone and, like any type of surgical procedure, has its share of problems.

Since the procedure was approved by the Food and Drug Administration in 1998, millions of Lasik surgeries have been performed in the United States. It now ranks as the most popular elective surgical procedure in the country, with more than 700,000 surgeries performed annually.

More than 95% of patients who undergo Lasik are pleased with the results, according to a recent analysis by the American Society of Cataract and Refractive Surgery. "For the vast majority of people, Lasik is not only safe and effective, but patients are happy afterward," says Dr. Jayne Weiss, director of refractive surgery at the Kresge Eye Institute, Wayne State University School of Medicine.

Most patients, that is. Between 1998 and 2006, the FDA received 140 complaints from dissatisfied Lasik patients. In April, the agency's ophthalmic devices panel heard testimony from a number of them.

Some had had side effects, others had experienced true complications. Side effects such as dry eyes and night vision problems (halos and glare) are a direct result of the surgery itself and are relatively common after Lasik. Changes in the shape of the cornea alter the way light enters the eye and are responsible for the visual disturbances; dry eyes, on the other hand, are a result of nerves to the cornea being cut during the procedure. Though rarely debilitating, these side effects can be difficult to prevent.

Sight-threatening complications, on the other hand, are rare -- but largely preventable if patients seeking Lasik are properly screened. "Twenty [percent] to 30% of people who walk in to get Lasik get sent away without it," says Weiss, who chaired the ophthalmic devices panel. "In my practice, it's closer to 50%."

Physicians can, to a degree, predict the likelihood of serious complications and identify patients who should avoid having the procedure. "There are two major contraindications," says Michael Colvard, associate professor of ophthalmology at the Doheny Eye Institute, USC Keck School of Medicine. "Some people have corneas that are too thin; others have irregularities in the contour of the cornea that make the procedure more risky."

Prospective patients with unreasonable expectations might also be better off not having the surgery. For most people, Lasik won't provide a lifetime of great vision without glasses. In some cases, results simply diminish over time; in others, age-related changes develop that can damage vision. Although these problems can sometimes be fixed with a second Lasik procedure, glasses or contacts are often the only solution.

In its study, the FDA, along with the National Eye Institute, American Academy of Ophthalmology and the American Society of Cataract and Refractive Surgery, will look not only at patient satisfaction after Lasik but also at patients' ability to perform daily activities such as driving and exercising. Despite the fact that most people make the decision to have Lasik based largely on quality-of-life issues, these postoperative outcomes have never been closely studied.

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