Survey Finds Many Experience New Problems After LASIK

By Andrew M. Seaman

November 28, 2016

(Reuters Health) - Many people who undergo laser in situ keratomileusis (LASIK) surgery to correct their vision experience new eye problems months after the procedure, according to a new study from the U.S. government.

The new problems were generally minor and didn't harm people's ability to function normally, the researchers found. And in most cases, patients' initial vision problems had been addressed by the procedure.

"More research is needed to understand which patients are likely to experience difficulty performing their usual activities following LASIK surgery," the U.S. Food and Drug Administration said in a statement to Reuters Health.

LASIK uses a laser to reshape the cornea of the eye. The procedure allows light to properly enter the eye and ultimately correct vision problems like nearsightedness, farsightedness and astigmatism.

Dr. Malvina Eydelman of the FDA and colleagues write in JAMA Ophthalmology November 23rd that patients sometimes report problems after LASIK, including dry eye, glare, halos, starbursts and general dissatisfaction with the surgery.

Studies looking at these symptoms haven't focused on how they affect people's lives, they add. Also, studies have been limited by the type of surveys researchers used.

The new research used data from two studies meant to evaluate a new survey designed for people undergoing LASIK.

The Patient-Reported Outcomes With LASIK (PROWL) studies included 240 active military personnel and 271 civilians, all of whom took the survey before the surgery and three months later.

Before the surgery, not surprisingly, people had vision problems and were unhappy with their eyesight. Those complaints decreased after the surgery.

However, 43 percent of participants in one PROWL study and 46 percent in the other study reported new vision problems three months after the surgery. Those included glares, halos, double images and starbursts.

Patients were more likely to report those symptoms on the survey than to inform their doctors.

The FDA points out that less than 1 percent of the participants experienced "a lot of difficulty" with usual activities after LASIK surgery due to visual symptoms.

Additionally, the statement said the vast majority of participants were happy with their vision after their surgeries.

The new survey used in this study will help assess people's symptoms before surgery and monitor them for new problems and satisfaction after the procedure, the agency wrote.

"By continuing to listen to the patient's perspective during the development, evaluation and use of medical devices, the FDA and manufacturers can work together to better assure that LASIK devices marketed in the United States address patients' needs," according to the statement.


JAMA Ophthalmol 2016.