Lauranell Burch is one patient who is not happy with the results.
While working at Duke University, Burch received a mailing to employees that touted the benefits of the university's laser eye surgery. A senior medical researcher, Burch did her homework before undergoing the LASIK procedure, which stands for Laser-Assisted In Situ Keratomileusis, in March 2004. She read the clinical trials with interest and combed the Internet for details. Still, she says, she didn't get the whole story.
"No one has received full informed consent for LASIK," Burch said. "If anyone knew what this procedure really does to their eyes, they wouldn't have it."
Still, 28.3 million people worldwide have decided to undergo the surgery since the mid-'90s to improve their sight. LASIK doctors say complications from the eye surgery are rare, and a study published in January's American Journal of Ophthalmology showed the benefits of LASIK can last a decade. LASIK's industry group insists patients are satisfied by the results of the procedure.
"When we look at outcomes of LASIK - 20/20 rates - our outcomes of LASIK today are better than they have ever been," said Dr. Kerry Solomon, professor of ophthalmology at the Medical University of South Carolina. "The technology has advanced to the point that there has never been a better time to undergo LASIK eye surgery. Our outcomes are better and these procedures are safer."
Nonetheless, after receiving reports of double vision, night blindness, dry eye and halos, the Food and Drug Administration is taking another look at LASIK. On April 25, experts will hear from patients and review what's known about the experiences of approximately 700,000 patients who undergo LASIK each year in the United States. The FDA received 140 comments about LASIK dissatisfaction between 1998 and 2006.
The FDA, the National Eye Institute, the American Society of Cataract and Refractive Surgery and the American Academy of Ophthalmology are further assessing patient quality of life after LASIK.
"This is not about safety and effectiveness of LASIK surgery at all," Solomon said. "This is about trying to take a very safe and very successful procedure and trying to learn as much as we can about trying to make it more successful."
But in Roger Davis' experiences, many people are unhappy due to complications from the surgery. Davis, a researcher with a Ph.D. in clinical psychology, said he often hears from patients who are battling depression and thoughts of suicide after surgery. Davis had LASIK surgery in 1998 and now experiences dry eyes, irregular astigmatism and some ghosting in his right eye.
"Anytime that you have a catastrophic physical injury, you're going to have a period of physical distress," Davis said. "I don't think catastrophic LASIK surgery is any different."
"If you look at the research submitted to the FDA, I'd say the quality of life data wasn't that good," Davis added.
According to the FDA, it could take as many as three to six months for vision to stabilize after surgery. During that time, the agency notes that people may experience glare and halos, and have a difficult time driving at night. The FDA also outlines the risks associated with LASIK on its Web site.
But patients like Burch said the problems persisted much longer and said clinical trials failed to inform her that LASIK patients were losing contrast sensitivity, which enables people to distinguish an object from its background.
"I feel like someone threw sand in my eyes everyday," said Burch, who now works for a branch of the National Institutes of Health. "My eyes sting and burn."
