FDA wants transparency on LASIK risk, from vision problems to depression
The FDA wants manufacturers to offer a checklist so people are informed before they choose the eye-correcting surgery
When the Food and Drug Administration asked for comments on its proposed guidance for consumers considering LASIK eye surgery this summer, the responses ranged from “exuberantly happy” to “it destroyed my life.”
The regulatory agency believes that patients need more information about the potential risks and complications of LASIK surgery, which is shorthand for laser-assisted in situ keratomileusis. In LASIK surgery, a laser is used to reshape the cornea to treat nearsightedness, farsightedness or astigmatism and in some cases eliminate the need for glasses.
According to Everyday Health, “To ensure that both doctors and patients have all the information they need to make an informed decision, the FDA is recommending that manufacturers provide physicians and patients with a ‘patient decision checklist’” prior to a LASIK procedure.
The checklist warns people that certain conditions, including diabetes, dry eyes and a weakened immune system, could put people at greater risk of complications. And the complications can be serious, including permanent loss of vision, double vision, retinal detachment, dry eye and pain. The draft guidance also notes that some people will still need glasses following the surgery.
FDA also said some patients have experienced severe depression and even suicidality that could be related to complications following LASIK, though a causal link has not been proven.
The checklist would be recommended, but not required.
According to The New York Times, “If put into effect, the agency’s warnings are likely to come as a surprise to many Americans, who view the procedure as safe and commonplace. Every year, more than half a million adults undergo LASIK surgery to correct poor vision.”
The article quoted ophthalmologists calling LASIK safe and noting that serious, long-lived complications are unusual.
“All we’re asking for is balance,” Dr. Vance Thompson, incoming vice president of the American Society of Cataract and Refractive Surgery, told The New York Times. “This document mainly emphasizes the dangers and complications of LASIK, with no mention of the advantages, and the tone is negative enough that it will scare patients.”
He said that 90% of patients in FDA studies are very happy with the eye-correcting surgery.
Some optometrists — those who prescribe glasses — are among medical providers who say patients are not getting enough information about the risks before they opt for the surgery.
The draft guidance says that “LASIK may cause or worsen visual symptoms, such as glare, halos, starbursts and ghost images/double images, most commonly experienced in dim lighting conditions as well as blurred and fluctuating vision.”
The guidance says that at six months post-surgery, more than a quarter of patients have dry-eye symptoms, and more than 40% have some visual symptoms, though long-term that remains true for only about 17%. Also at six months, about 1 in 25 patients have “very” or “extremely” bothersome symptoms. And 2% of those who had the surgery may find it difficult or impossible to do certain activities without glasses or contact lenses, the report said.
It notes the problems typically go away within three to six months, but can be permanent. And while symptoms are often mild, in some cases they can be “severe enough to cause difficulties in performing daily tasks. A common complaint is difficulty with driving at night,” which remains true for about 1 in 12 people who had the surgery.
The draft guidance notes “very rare reports (estimated rate of less than 0.8%) of severe, constant pain that may prevent normal activities.”