The U.S. Food and Drug Administration (FDA) approved LASIK eye surgery more than 25 years ago as a safe (albeit expensive) alternative to glasses and contact lenses. Now the agency is recommending new guidance for people considering the procedure that better details LASIK’s risks and potential complications.
“Since the time of the LASIK Advisory Committee meeting in 2008, the FDA has continued to gather new information pertaining to risks associated with LASIK, including dry eye, pain and discomfort, and visual symptoms,” said a spokesperson for the FDA in an email. Both clinical and scientific knowledge about these adverse events and symptoms has increased since that last advisory meeting, they said.
FDA Recommends a Patient Checklist That Explains LASIK Risks
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, said the spokesperson.
The checklist includes a list of several conditions that may put a person at risk for problems related to the surgery, including controlled and uncontrolled diabetes, dry eyes, or a weakened immune system.
The guidance outlines the risk of complications from the surgery, including permanent loss of vision, double vision, retinal detachment, dry eye, and pain. It also warns about “potential risk of psychological harm,” because of reports that some LASIK patients have experienced severe depression or suicidality they believe is related to complications following the procedure. No definitive causal link between the surgery and the reported psychological harms has been established, the report stated.
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More Than Half a Million People Get LASIK Each Year
LASIK — which stands for laser-assisted in situ keratomileusis — is performed with a special type of cutting laser used to change the shape of the cornea to improve vision. The outpatient surgery takes about 30 minutes.
More than half a million people get LASIK each year, at a cost of anywhere from $1,000 to $4,000 per eye, according to a Forbes report. In most cases, the procedure is considered cosmetic and therefore not covered by health or vision insurance.
Many famous athletes and celebrities, including LeBron James, Tiger Woods, and Kim Kardashian have all “gone under the laser” to correct their vision.
Patient Reactions to LASIK Experience Vary, From ‘Exuberantly Happy’ to ‘Destroyed My Life’
The FDA issued the lengthy draft guidance for patients in July 2022. The document was published in the Federal Register, and members of the public had until November 25, 2022, to express their thoughts on the proposal.
Of the 640 submitted comments, a significant number were from people who had LASIK surgery, and those comments ranged from “exuberantly happy with my decision” to “It has destroyed my life.” Another respondent detailed numerous complications they say they experienced because of the surgery, and that, “if I was properly informed that I could have experienced these complications, I would have never had LASIK.”
Now that the comment period has closed, the FDA is reviewing and considering comments for the final guidance. “The timeline for the final guidance issuing is dependent on a number of factors, and we cannot provide a firm timeline at this point,” said the FDA spokesperson.
FDA Guidance on LASIK Took Over 13 Years to Develop
To create the draft, the FDA collaborated with external partners, experts, and patient groups to better understand and describe the risks and ensure the recommendations addressed the concerns uncovered in this collaboration, said the FDA spokesperson. All told, the process has taken more than 13 years.
“For example, the FDA collaborated with the National Eye Institute and the Department of Defense to conduct research as part of the LASIK Quality of Life Collaboration Project to help better understand the potential risk of problems that can occur after LASIK,” said the spokesperson.
That project led to the development of the Patient-Reported Outcomes with LASIK (PROWL) Symptoms and Satisfaction questionnaire study, which included 574 people (split into two groups) who had undergone LASIK.
Investigators found that between 43 and 46 percent of people reported new visual symptoms three months after surgery. But the overall satisfaction rate among the groups ranged from 96 to 99 percent, according to the findings of the PROWL study, published in January 2017 in JAMA Ophthalmology.
Eye Health Professionals Are Divided on FDA’s Proposed Recommendations
The American Optometric Association (AOA), an organization that represents more than 48,000 optometry doctors, students, and professionals, expressed their agreement that “patients receive fully transparent information on the risks and benefits,” of the surgery and said “the AOA believes this guidance to be timely and beneficial.”
Not all eye-health professionals agree with the proposed changes, however. Critics of the draft believe it lacks balance: The potential benefits of the surgery (ideally, improved vision that no longer requires glasses or contact lenses) are mentioned, they say, but the bulk of the 25-page document is dedicated to outlining the potential risks.
The American Society of Cataract and Refractive Surgery called for the FDA to withdraw the draft, calling it “highly biased and misleading to potential patients regarding the extraordinarily high success rate of LASIK surgery.”
A Simpler Patient Guide for LASIK Would Be More Useful, Say Critics
Although a more understandable and accurate picture of LASIK risks and benefits is a good idea, this draft falls short, according to a statement from the National Center for Health Research (NCHR), a nonprofit think tank that analyzes research on medical and other consumer products.
Information provided in the document booklet is too detailed and uses scientific language that the average consumer can’t understand, the group said. The draft recommendations are so long and complicated that “few patients will read all the information about risks, contraindications, and warnings.”
The group strongly urged the FDA to require the labeling (as it stands now, providing the information would be optional) and improve their example of a LASIK Patient Checklist to provide more balanced information about risks. “This is necessary to give patients the information many have told the FDA that they wish they had known before their LASIK procedure,” read the statement.
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