FDA Releases New Guidance Regarding LASIK Risks and Benefits for Patients
To ensure eye surgery patients are properly warned about the benefits and risks of LASIK procedures, federal regulators are proposing new guidance for healthcare providers, and calling for more detailed patient guides and warning statements.
The Food and Drug Administration (FDA) issued new recommendations for Laser-assisted in situ keratomileusis (LASIK) labeling and warnings this week, and indicates the draft guidance may become final after comments are submitted over the next three months.
LASIK is an outpatient surgical procedure that permanently reshapes the cornea to change the way the eye focuses light rays onto the retina at the back of the eye. The popular laser eye surgery is intended to correct common vision problems, such as nearsightedness, farsightedness, and astigmatism, and to reduce a person’s dependency on eyeglasses and contact lenses.
The draft guidance is intended to provide comprehensive labeling which clearly describes the risks involved with LASIK surgery. Risks to the patient can include dry eye, pain and discomfort, and visual symptoms following treatment.
A study published in 2014 indicated nearly half of all LASIK patients suffer visual side effects following the procedure. To that end, the FDA launched the Patient-reported Outcomes with LASIK Symptoms and Satisfaction (PROWL-SS) tool to help assess patient symptoms and satisfaction following the procedure and to track side effects more closely.
The draft guidance details recommendations for the content and format of patient labeling for LASIK devices. The guidance includes information about the surgical procedure itself and what it entails, as well as indications for use and benefits. It also includes procedure alternatives, contraindications, warnings and precautions, risks, and what to expect before, during and after surgery, as well as clinical study information and manufacturer contact information.
The FDA also proposed inclusion of a patient decision checklist as part of the patient labeling information doctors should provide before the procedure. The checklist details who are good candidates for LASIK, what to expect after surgery, and a summary of long-term risks of the procedure.
The draft guidance also calls for the patient and doctor to sign the checklist to acknowledge it was read and discussed with the patient prior to the procedure.
LASIK providers have been cited for misleading advertising after the FDA determined the ads did not adequately convey the side effects patients may experience after the procedure. This is part of the concern that led the FDA to issue the new guidance.
“These proposed labeling recommendations, based on extensive consultation with stakeholders and patients, are intended to present information about LASIK in language that is easy to read and understand and include images that convey visual symptoms that could occur following LASIK,” Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health said in a July 27 press release. “The draft guidance is designed to support discussions that patients should have with their eye care providers about the benefits and risks of LASIK to help them make informed decisions before proceeding with the surgery.”
The FDA plans to continue to monitor the latest scientific data related to the LASIK procedure to ensure necessary information is provided to patients prior to surgery.
The agency encourages public comment and feedback on the draft guidance from patients, doctors and industry professionals before the guidance becomes final. Comments are being accepted until October 26, 2022.
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