Dec. 20, 2019 -- LASIK has been FDA-approved to correct vision since 1999. Today, doctors perform about 600,000 LASIK procedures in the United States each year. Most people who have this surgery end up with 20/20 vision, and the vast majority -- more than 95% -- say they're happy with the results.
Yet side effects like glare and halos are common after LASIK. And rarely, people have even lost vision or had long-term pain or other problems.
Morris Waxler, PhD, the former FDA official who was part of the original team that approved the procedure, has in recent years claimed the FDA has downplayed the risks. He's asked the agency to pull LASIK from the market. The FDA responded that the evidence doesn't justify a recall, but it has promised to keep monitoring LASIK safety.
Is LASIK safe? Yes, says Edward Manche, MD, a professor of ophthalmology and division chief of Cornea and Refractive Surgery at Stanford University School of Medicine. "The FDA has approved it and reaffirmed its safety," he says. "There are certainly patients who've had some problems, but the vast majority of people do extremely well."
LASIK, which stands for laser-assisted in situ keratomileusis, is a type of refractive surgery. The surgeon first cuts a thin flap of tissue from the front of the eye. Then, a laser burns away tissue to reshape the cornea so that light focuses better on the retina in the back of the eye. LASIK can correct vision problems like nearsightedness, farsightedness, and astigmatism.
In the 20 years since LASIK has been around, doctors in the U.S. have performed more than 19 million of these procedures. There haven't been many high-quality, long-term studies done on the outcomes, but the research that does exist finds the procedure to be safe and effective.
"LASIK is a really good procedure," says Jennifer Ling, MD, a clinical assistant professor in the Cornea and External Eye Disease Clinic at University of Iowa Hospitals & Clinics. "It’s been able to change the lives of a lot of people, giving them excellent vision and letting them be free of their glasses or contact lenses."
More than 90% of people who have LASIK achieve 20/20 vision, meaning they can see from 20 feet away what a person with normal vision should be able to see at that distance, without glasses or contact lenses. More than 99% of people end up with 20/40 or better vision, which is clear enough to pass a driver's license exam.
Daniel Sklar, a 56-year-old strategic consultant from Smyrna, GA, had the procedure done in 1999 to correct severe nearsightedness and astigmatism. Afterward, he went from needing thick glasses to having better than 20/20 vision. "It has been a tremendous quality of life improvement," he says. "Just to be able to wake up and take a shower and see, and go swimming or snorkeling without any prescription goggles."
Improvements in the procedure over the years have made LASIK even more effective. "The results have gotten steadily better and better over time as we've gotten more advanced technology," says Joshua Frenkel, MD, an associate surgeon at Wang Vision Institute in Nashville. The femtosecond laser, introduced in 2001, uses pulses of light to cut a flap in the cornea. Femtosecond lasers have revolutionized the procedure, offering greater safety and precision than a blade.
Other advances in technology allow the creation of a customized map of the cornea, which allows for more precise vision correction and better outcomes. "The idea is to reduce higher-order aberrations, which can cause glare, halos at night, and things like that," Frenkel says.
The main side effects with LASIK are mild -- including dry eye, burning, and itching, which affect 20% to 40% of people who have the procedure. These symptoms usually peak around 3 months after the surgery and disappear within 6 to 12 months -- but not always.
Holly Strawbridge, a 68-year-old freelance writer in Fort Lauderdale, FL, has had dry, red eyes since her LASIK procedure about 17 years ago. "It's been a problem," she says. "I look like I've been pulling all-nighters a lot." Had she known about the dryness ahead of time, she says she still would have gone ahead with the surgery. "Frankly, when you compare it to not being able to see, dry eye takes a back seat."
Also common are glare and halos around lights at night, and difficulty with contrast. These problems affect about 20% of people who have LASIK. They also can improve over 6 to 12 months, but in a small number of people, they continue long-term, Manche says. If you have one of these issues, you can go back to wearing glasses or contacts, or have revision surgery.
There's also a small chance LASIK may not completely correct your vision, especially if you were very nearsighted or farsighted to start. If this happens, you'll need glasses or contacts to see clearly. "If you're not fully corrected … you can return after 3 to 6 months and have an additional surgery," Manche says. "In those cases, the vast majority of patients do achieve 20/20 vision."
Very rarely, it's possible to lose lines of vision on a vision chart. "Even with glasses or contact lenses, vision can't be corrected back to what it was before LASIK," Ling says. "The risk of that is very low. This is often due to an infection, scarring, or poor healing."
Even if your vision is 20/20 right after LASIK, it may not stay that way. It is possible for vision to regress. And as you get older and the shape of your eye naturally changes, you'll probably need to start reaching for reading glasses. "As I've gotten older I've lost the effect of LASIK," Strawbridge says. "But I got at least 10 years of perfect vision."
Most LASIK-related problems are temporary and only a mild nuisance, but in certain people, they're severe enough to be life-changing. Christian Athanasoulas had the procedure in May 2015, when he was 44. He went to a reputable hospital and had tests to make sure he was a good candidate. But afterward, he developed dry eye. Treatments like tear plugs and prescription eyedrops didn't help, and the dryness continued to get worse.
"By 12 to 15 months after the procedure, the dry eye sensation seemed to morph into throbbing pain," Athanasoulas says. "I felt like someone was sticking knives through my eye, all the way through my head." The pain eased only when he was asleep.
Two years after his procedure, Athanasoulas saw a specialist, who diagnosed him with corneal neuralgia -- pain caused by damaged nerves in the cornea. It's a rare but debilitating side effect that's been linked to LASIK surgery in a small number of cases.
Now he's on a battery of treatments -- eye drops made from his own blood, steroid drops, and pills to calm the nerve pain. "My pain went from 9 out of 10 on a daily basis to anywhere from 1 to 2 on a good day, to 6 to 7 on a bad day."
Despite having clear vision, when asked if he'd do it again, he says, "Never."
"My perspective on the risk-reward has certainly changed."
Hearing stories like Athanasoulas's from people who've been hurt by the surgery inspired Waxler to push for clearer warnings about the risks of LASIK, which he's been doing for more than 12 years. One of the most public of these cases was Jessica Starr, a Detroit meteorologist who died by suicide in December 2018, at age 35, after sharing her struggle with LASIK complications with her viewers. (It's not clear whether the suicide was directly related to her surgery.)
Another issue with LASIK is its cost -- $2,200 per eye, on average. "With rare exception, it's not covered by insurance," Manche says. You can use your flexible spending account (FSA) or health savings account (HSA) to pay for the surgery.
Getting the Best Outcome
LASIK isn't a good fit for everyone. "The most important thing is to make sure you are a good candidate," says Manche. "Some people may develop complications, not because of the surgery, but because they aren't good candidates."
"Every person needs to have a very thorough one-on-one evaluation and consultation with their doctor to make sure LASIK is right for them," Ling says. The doctor who does your surgery should do a thorough eye exam beforehand, checking the shape of your cornea and looking for problems like dryness or other undiagnosed eye conditions.
LASIK isn't a good fit for certain people. You may need to avoid this surgery if:
- Your cornea is too thin or uneven
- You have cataracts or glaucoma
- You have uncontrolled diabetes or an autoimmune disease such as Sjögren's syndrome or rheumatoid arthritis
- You're pregnant
- You're under 18
One key to a successful outcome is finding an experienced doctor. You can ask friends and family who've had LASIK for a recommendation, or check with the American Academy of Ophthalmology. Manche suggests getting a second opinion. "That way, you'll feel more confident if two doctors say the same thing."
The doctor should take their time and explain the procedure very clearly, being upfront about the possible risks. "You don't want the doctor who says, 'This is absolutely guaranteed to work. You're going to love it,'" Ling says. "That's a big red flag." Going to a university medical center may be a safer bet than a private practice, she says.
You also need to have realistic expectations going into LASIK. About 90% of people will achieve 20/20 uncorrected vision or better, but 10% of people won't, and up to 40% will have side effects. "Generally, the higher your prescription was, the higher your risk of side effects," Ling says.
"I think a lot of people believe that LASIK is 100% guaranteed. For the vast majority of people, it is a highly successful surgery. But nothing in medicine is a 100% guarantee," she says. "If somebody goes into LASIK thinking they are guaranteed 20/20 vision without any risks, they have been improperly counseled, and they may be disappointed."