LASIK Patients Should Be Warned of Complications, F.D.A. Draft Says
Draft recommendations by the agency describe dry eyes, visual disturbances, and other side effects of the procedure. Surgeons say the benefits are being ignored.”
LASIK, or Laser-Assisted In Situ Keratomileusis, is a refractive surgery that reshapes the cornea (front clear dome of the eye) with the intent to reduce or eliminate the dependence on glasses or contact lenses.
The FDA’s draft recommendations emphasize careful patient selection to reduce the risk of a bad outcome. Only when patients are fully informed can they make a valid choice and consent to the potential risks. Too many surgeons dismiss these risks, as poor outcomes are uncommon. The VCDC only refers to surgeons who thoroughly counsel patients as to the risks and benefits of refractive surgery, and who will refuse to perform surgery on patients who have elevated risk.
LASIK can provide a positive life-changing experience for the mom who used to wear -10 glasses or contact lenses, and now can easily get up in the night to care for her child. It can provide amazing opportunities for the active outdoorsman. It can be the safest option for a person who abuses their contact lenses. And it can be a devastating event for the patient left with pain and double vision, who can no longer work in their chosen field, or any other field requiring sharp, comfortable vision.
Ninety percent or more of LASIK patients are happy with their visual outcome, even if they have some mild adverse effects. Dry eyes and visual aberrations such as halos are common early on but diminish greatly by year 5. By that point, though, nearly 1 out of 5 patients still require eye drops, and up to 8 percent have some sort of visual impairment. As more than 20 million total LASIK surgeries have been performed in the USA, that leaves well over a million people with some sort of lingering problem, and over a quarter of a million people with significant visual problems. Problems caused by an elective surgery performed on healthy eyes.
The unhappy LASIK patients are not just disappointed, they’re often miserable.
Potential negative outcomes include chronic eye pain, glare and halos, reduced depth perception, difficulty driving at night, double vision, eyestrain, and headaches. A few patients have even become suicidal following a poor LASIK outcome.
At the VCDC, we treat many of the unhappy LASIK patients, the ones left with double vision or other binocular vision problems. We have also treated many patients who were struggling with reading or driving due to intractable dry eye after LASIK. In a previous practice, I fit specialty custom hard contact lenses on patients who had such irregular corneas they couldn’t get usable vision any other way, which is certainly not what they expected as the outcome from LASIK surgery.
Whenever my patients ask about LASIK, I admit I’m biased by the poor outcomes I have seen and point to my own glasses as evidence of my perspective.