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LASIK Dangers Require Caution

May 5, 2008 | Parker Waichman LLP LASIK—laser-assisted in situ keratomileusis—surgery involves using a laser to cut a small flap in the eye's cornea to allow for reshaping of the corneal tissue with another laser to correct nearsightedness, farsightedness and, sometimes, astigmatism.  LASIK was approved a decade ago and an estimated six million Americans have undergone LASIK surgery with hundreds of thousands of Americans undergoing LASIK yearly.  The surgery permanently reshapes the cornea, there are no guarantees of 20/20 vision, and the long-term safety of LASIK remains unknown.

Recent testimony before an advisory panel to the US Food and Drug Administration (FDA) is revealing that in as many as five percent of all cases, LASIK can be not only be ineffective, LASIK can lead to side effects that include severe dry eye, eye pain, blurred vision, and an inability to drive at night.  To date, the FDA has received 140 letters of complaints and "The FDA has called this a quality-of-life issue, because patients are complaining that their vision isn't sharp, they have poor night vision, some have glare or halos, some complain that their eyes are dry," said Dr. Robert Cykiert, associate professor of ophthalmology at New York University Langone Medical Center.  FDA advisers recommended the agency clarify warnings regarding LASIK, including:  Photographs to clearly show what people with side effects see, such as glares and light bursts; information indicating how often patients suffer side effects, such as dry eye; and clear information outlining the conditions under which someone should be dis
qualified from LASIK, such as large pupils or severe nearsightedness.

Those considering LASIK should be fully evaluated in advance for conditions such as dry eye, which affects an estimated 10 million Americans and is a painful condition in which there is a reduction in either the quality or quantity of tears, necessary to maintain ocular lubrication.  Contact lens, birth control pills, antihypertensive medications, and antihistamine use can lead to dry eye.  Those with moderate-to-severe dry eye should be advised prior to LASIK surgery since the eye will certainly be drier afterward, said Dr. Ernest Kornmehl, a LASIK surgeon in Wellesley and a spokesman for the American Academy of Ophthalmology.  Kornmehl warns that some surgeons don't see their patients until the day of surgery, which means that initial exams and conversations were left to someone else increasing the likelihood that pre-existing conditions—such as dry eye—are missed.

Patients should speak to their surgeons directly and ask how many LASIK procedures the surgeon has conducted and when.  Look for a physician who is fellowship-trained in corneal diseases and, "You have to choose your physician carefully," said Darlene Dartt, director of scientific affairs at Schepens Eye Research Institute.  "And go to a reputable place where you are carefully screened, to make sure your eye is properly evaluated."

Dr. Norman Saffra, director of ophthalmology at Maimonides Medical Center in New York City, says that LASIK is not for everyone, especially those with a misshapen or excessively thin cornea, early cataract formation or big pupils, dry eyes, or underlying conditions such as lupus or rheumatoid arthritis.   In addition to glare and halos side effects, some patients have had corneal transplants, Starr said.

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