For Some, Lasik Brings More Problems Than Solutions An increasing number of patients say they have experienced significant complications after Lasik. Problems like dry eye, glare and double vision have impaired their ability to function and significantly affected their quality of life. The FDA has decided to investigate further and hopes to identify what puts people at risk for complications.
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For Some, Lasik Brings More Problems Than Solutions

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For Some, Lasik Brings More Problems Than Solutions

For Some, Lasik Brings More Problems Than Solutions

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You can't avoid the ads for Lasik surgery.

(Soundbite of advertisement)

Unidentified Man: Yesterday, you depended on glasses. Today, you can choose Lasik.

AMOS: Over the last decade, millions of Americans have opted for the surgery, and for most, their vision is nearly perfect and theyre happy - but not everyone.


A rise in patient complaints about side effects has prompted the Food and Drug Administration to take a closer at Lasik. NPRs Patti Neighmond has more.

PATTI NEIGHMOND: During Lasik eye surgery, doctors use a laser to vaporize portions of the cornea, reshaping it for better vision. Its a relatively quick, simple outpatient procedure. But for some patients, the end result is not what they expected. Dr. Malvina Eydelman is with the FDA.

Dr. MALVINA EYDELMAN (Food and Drug Administration): They were reporting symptoms such as dry eyes, glare, starbursts and double vision, which was significantly affecting their quality of life.

NEIGHMOND: Take Paula Cofer, for example, who had Lasik in 2000.

Ms. PAULA COFER: The first thing I noticed was that my right eye was very blurry. My left eye seemed pretty good in the daylight, but both eyes were very distorted at night. And I developed severe, persistent dry eyes.

NEIGHMOND: Which may not sound like a big problem, says Cofer, but make no mistake, she says. Its huge.

Ms. COFER: For me, its severe, constant burning. My eyes burn all the time.

NEIGHMOND: Theyre painful and require constant attention - eye drops, eye rinses, eyelid scrubs, a mask at night to keep dry air away from her eyes. She's had her tear ducts plugged to keep tears from draining away and finally, there's the moisture-retaining goggles.

Ms. COFER: I look like a fly. They're very unattractive. I hate to wear them because they're so unattractive, but...

NEIGHMOND: They work. So Cofer wears them inside, where fans create lots of dry air -like at the gym. And she wears them outside when air is dry, like on a windy day. Cofer also suffers halos and glare at night.

Ms. COFER: I can't see. If I drive a car at night, my vision is totally impaired. I'm not safe to drive. I can't see pedestrians on the side of the road.

NEIGHMOND: And the coup de grace: Cofer still needs glasses and contacts. Bottom line, she was simply not a good candidate for Lasik. Her large pupils make laser correction difficult, and for some reason she's prone to severe dry eye. But she says no one told her about these potential problems. The FDA's Eydelman says the agency has stepped up its efforts to ensure doctors provide patients with information about risks and precautions before having Lasik. That includes things like large pupils, thin corneas and undiagnosed dry eye.

Eydelman says the agency's also looking into misleading claims.

Dr. EYDELMAN: You can't, for example, promise vision free of glasses. Patients need to make sure that they understand even in the perfect-case scenarios, they dont need glasses for distance vision. There's a very high likelihood that they will need reading glasses. So something like a spectacle-free existence is obviously a misleading claim.

NEIGHMOND: And so is a guarantee of 20/20 vision.

The FDA's also begun a study, which will include thousands of Lasik patients nationwide, to figure out just how many suffer severe complications and why. The hope is to better predict good candidates for Lasik.

Dr. Sanjay Patel is a researcher and specialist in corneal surgery at the Mayo Clinic. He says the study findings will be helpful.

Dr. SANJAY PATEL (Corneal Surgery Specialist, Mayo Clinic): Right now, we do not have good data to actually give patients a percentage to say, there's an X percent chance that you're going to have dry eyes after refractive surgery. There are no good, large data series that give us those numbers.

NEIGHMOND: The FDA hopes to complete its study by 2012. In the meantime, Dr. Marguerite McDonald, who practices in New York and is spokesperson for the American Academy of Ophthalmology, says recent advances should help complications like dry eye.

Dr. MARGUERITE McDONALD (Spokeswoman, American Academy of Ophthalmology): Ten years ago, it was treatable, but we didn't have as many things in our bag of tricks. Now, we have a lot of things that can treat dry eye. They say never say never, but I have personally not encountered someone who couldn't be treated very successfully.

NEIGHMOND: There have been advances in laser technology too, says McDonald, which have decreased the risk of nighttime halos and glare.

Dr. MCDONALD: Wavefront-guided Lasik allows us to measure thousands and thousands of data points that define the optical pathway in each eye. That can now be measured, and small aberrations can be fixed.

NEIGHMOND: The FDA says it's encouraging patients to report any severe problems with Lasik - not only to the doctor who performed the surgery, but to the federal agency as well. Patti Neighmond, NPR News.

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