October 4, 2022
FDA Draft Guidance on LASIK Benefits and Risks

FDA Draft Guidance on LASIK Benefits and Risks

The US Food and Drug Administration released a draft advice to assist ensure that patients and health care providers have access to information that properly communicates the advantages and hazards of LASIK devices. “It is critical that patients get thorough labelling that properly exposes the risks associated with LASIK surgery, including potential side effects such as dry eye, pain and discomfort and vision impairments.” said Dr. Jeff Shuren of the FDA’s Center for Devices and Radiological Health. “These proposed labelling suggestions are designed to communicate information about LASIK in easy-to-read and intelligible language, and to add graphics that describe visual symptoms that may occur following LASIK, based on extensive consultation with stakeholders and patients.” The draught advice is intended to promote talks between patients and their eye care providers regarding the advantages and dangers of LASIK in order for them to make educated decisions before undergoing the procedure.

The most well-known and extensively utilised laser refractive surgery to correct vision impairments is LASIK eye surgery. Lasik (laser-assisted in situ keratomileusis) can be used instead of spectacles or contact lenses. LASIK surgery uses a specific type of cutting laser to precisely adjust the shape of the dome-shaped translucent tissue at the front of your eye (cornea) to improve vision. It is an outpatient surgical treatment that permanently changes the way the cornea focuses light rays onto the retina at the rear of the eye. LASIK surgery is designed to treat common vision disorders like near-sightedness, farsightedness, and astigmatism while also reducing a person’s reliance on eyeglasses and contact lenses. In normal vision, the cornea accurately bends (refracts) light onto the retina at the rear of the eye. However, whether a person has near-sightedness (myopia), farsightedness (hyperopia), or astigmatism, the light is bent improperly, resulting in impaired vision. Although glasses or contact lenses can be used to correct eyesight, reshaping the cornea will also offer the proper refraction.

The proposal guidance of Laser-Assisted In-Situ Keratomileusis (LASIK) Laser-Patient Labelling Recommendations are:
  • FDA’s proposed recommendations for the content and format of LASIK device patient labelling, including general information about the surgical procedure.
  • Indications for use; benefits; procedure alternatives; contraindications, warnings, and precautions and risks.
  • What to expect before, during and after surgery.
  • Clinical study information and manufacturer information.
  • Furthermore, the proposed advice suggests including a patient decision checklist in the patient labelling material that physicians present to their patients before the treatment.
  • Ensure that patients understand the patient choice checklist, the recommended checklist covers, among other things, who is a good candidate for LASIK.
  • What to expect following surgery and a synopsis of the procedure’s long-term hazards. It also suggests that the patient and doctor sign the checklist to acknowledge that it has been read and discussed.
  • The FDA cooperated with external experts on research activities that impacted the draught guidance’s recommendations.
  • The agency conducted research as part of the LASIK Quality of Life Partnership Project, in collaboration with the National Eye Institute and the Department of Défense, to assist a better understanding of the possible risk of complications that can emerge following LASIK.
  • This research resulted in the creation of the Patient-Reported Outcomes with LASIK PROWL Symptoms and Satisfaction (PROWL-SS) questionnaire, which was approved by the FDA’s Medical Device Development Tools (MDDT) programme.
  • The FDA is soliciting comments on proposed labelling recommendations from patients, health care professionals and stakeholders by providing draught guidance for public comment.

When it comes to LASIK eye surgery, there are no right or wrong solutions. Consider the factors outlined above carefully, analyse your preferences and risk tolerance, and make sure your expectations are reasonable. Speak with a trusted eye surgeon and have your questions addressed. Finally, if it seems right, go forward, but if it doesn’t, don’t hurry into anything. As new information about LASIK devices becomes available, the FDA will continue to evaluate the latest scientific research and collaborate with professional medical societies and patient advocacy groups to ensure that risk information regarding LASIK devices is shared with patients.

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