Study: LASIK patients see some side effects




Millions of Americans each year undergo LASIK surgery to correct vision. Given how common the procedure has become and how ubiquitous the ads are on radio and TV, you might be tempted to treat the decision to get the treatment casually or think of it as a financial decision. A team of researchers from the Food and Drug Administration, the National Eye Institute and the Department of Defense would like to make sure patients weigh potential risks more seriously.

In 2009, as LASIK was becoming a household word, government scientists launched a major study to investigate reports of adverse impacts from the procedure.

The results, published in October 2014, showed some patients developed problems that adversely affected their day-to-day lives, such as difficulty driving at night or in sunshine. But it was such a small number — less than 1 percent — of the patients in the study that it was difficult to draw any strong conclusions.

The group released a follow-up report in JAMA Ophthalmology that provides more sobering information. The study suggests that the percentage of people who undergo LASIK and wind up with new visual symptoms — such as double images, glare, halos or starbursts — may be much higher. The data was based on a questionnaire that looked at patient satisfaction with their vision and at visual and dry-eye symptoms following surgery.

More than 95 percent of participants said they were satisfied with the improvements to their vision. But a “substantial” percentage of study participants said they had new symptoms following the procedure.

The study analyzed outcomes for two groups of LASIK patients. In the first group, which included 262 Navy personnel, 43 percent reported symptoms. In the second, with 312 civilians at five practice and academic centers, it was 46 percent. In addition, about 28 percent of patients who had never had dry-eye symptoms before developed mild, moderate or severe symptoms three months after the procedure.

“To our knowledge, our study is one of the few that have reported the development of new visual symptoms,” Malvina Eydelman of the U.S. Food and Drug Administration and colleagues wrote. “While the overall prevalence of visual symptoms decreased, a large percentage of participants with no symptoms preoperatively reported new visual symptoms postoperatively.”

The survey showed the percentage of people with symptoms may be much higher than what has been previously reported in studies involving direct interviews with health care professionals. The authors of the new study note the reluctance of patients to tell their doctors about “negative” events has been documented.