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 disqualified from LASIK, such as large pupils or severe nearsightedness. (more…)