Those who are about to pass refractive surgery With Lasik Method to restore it vision them out myopia, farsightedness in astigmatismthey should be aware that they are at risk for serious complications such as diplopia, dry eyes, difficulty driving at night and, less commonly, persistent eye pain. This recommendation is expected to be published by the US Food and Drug Administration (FDA) soon.

The formalization of the recommendations will certainly surprise Americans, who consider these procedures to be “routine.” With the help of the Lasik method, the ophthalmologist changes its shape. cornea, a transparent dome that covers the eye and helps focus light on the retina at the back of the eye. The surgeon cuts a small strip in the cornea, folds it, and uses a laser to model the retina. Then he returns the small strip to its place.

The operation lasts 15 minutes on each eye and costs many thousands of dollars. The surgeons who perform it, citing studies, report that 90% of those operated on are satisfied, while promoting the operation with big discounts and free visits to the doctor.

Organizations representing ophthalmic surgeons launched an attack on the FDA, claiming that its recommendations simply scare patients, and the information contained in them speaks only one side. Many experts emphasize that the Lasik method is the safest for the eyes, and serious side effects are very rare.

What the FDA says

Commenting on the draft guidelines, Dr. Vance Thompson, new Vice President of the American Society for Cataract and Refractive Surgery, said: “All we ask for is balance. The FDA document highlights the risks and complications of Lasik, nowhere mentions the benefits of the procedure, and it is so risky that it scares patients.”

According to a US regulatory document, some patients who have surgery become severely depressed, even suicidal, due to complications from the surgery. In addition, pre-existing health problems such as diabetes or certain medications contribute to an unsatisfactory outcome of the operation.

The agency recommends that the patient be informed of all the risks of surgery before consenting to surgery, such as that retinal nerves may never heal after incisions, causing chronic eye pain or dry eyes. In their FDA comments, people who have undergone refractive surgery have reported that they have suffered life-changing complications, loss of vision, while others have been delighted with the procedure.

Critics of the invasive method point out that the FDA should issue a recommendation mainly because the method is used for healthy eyes, and not for the treatment of any disease.

Paula Cofer, a Florida woman who testified before the FDA in 2008 and 2018, says: “I waited 14 years for a warning. Lasik ruined my life by causing chronic pain in my left eye.” The American Optometric Association, professionals who test visual acuity and prescribe glasses and contact lenses, welcomed the draft FDA advisory/warning, adding that additional precautions need to be taken for pregnant women seeking refractive surgery. as for people with irregular astigmatism.

Finally, it’s worth noting that the alert the FDA wants to issue is based on a 2017 study of the results of Lasik procedures, which was conducted by the agency in collaboration with the National Eye Institute and the Department of Defense. According to her, even five years after the operation, 17% of those operated on still needed eye drops, 2% had visual impairment, and 8% had difficulty driving a car at night.