Health

What FDA Input Means for Risks and Benefits of LASIK


Jan. 17, 2023 – Two years ago, Benjamin Wilbur had LASIK surgery to correct his vision. “I have three youngish kids, and I felt I was constantly being hit in the face and my glasses were being knocked askew,” he says. He also didn’t like having “foggy” glasses when wearing a mask during the pandemic.

After a 10-minute consultation with an ophthalmologist, Wilbur, 37, a New Jersey-based pharmacy investigator, was deemed to be a good candidate. He had dryness in his eyes for a few weeks after the procedure, which he treated with artificial tears. Within 6 weeks, he no longer needed them.

“I was able to drive within 24 hours, and my eyesight was fine,” he says. “I’ve gone back for regular checkups and had my last one 3 months ago – I had 20/15 vision.”

Wilbur is pleased with the results. “I wish I had done it sooner,” he says.

LASIK, which stands for laser-assisted in situ keratomileusis, is designed to permanently alter the shape of the cornea (the clear covering of the front of the eye) using a particular type of laser technology. LASIK is extremely popular, with upward of 500,000 U.S. adults having the procedure. But the FDA has recently begun to shine a light on its risks.

And while most LASIK patients have experiences like Wilbur’s, the FDA last year released draft guidance for recommendations that doctors warn patients of the risks. The agency invited input from patients and doctors and has yet to issue a final report. The proposed guidance pushes for warnings about double vision, dry eyes, ongoing pain, and other issues. It even says people might still need eyeglasses after the surgery.

Lorrie Shank Tevebaugh, a Texas-based 53-year-old who works in HR, is a former LASIK patient who is among those who had a bad LASIK experience. Tevebaugh decided to have the surgery because she is an “avid hiker and runner and spends a lot of time on a boat” and wanted to do these activities without glasses.

She went to a reputable ophthalmologist and was told she was a good candidate for LASIK. “The procedure itself went smoothly,” she says.

But her vision remained blurred the next day, and she started to have eye pain. At her 24-hour postsurgical visit, she was assured that her eyes would continue to improve during the next 3 days. Instead, her vision continued to worsen.

By the following week, she couldn’t see anything other than shapes and colors. One of her eyes was swollen shut, and she was in pain. She was diagnosed with central toxic keratopathy, a rare complication.

Almost a year after the surgery, Tevebaugh still struggles with the damage. Her cornea has flattened. She wears special contact lenses that require a specialized liquid solution plus bifocal glasses. She regrets doing the procedure. “Had I heard of this ahead of time, I wouldn’t have done it.”

The FDA Impact

According to Peter Hersh, MD, director of the Cornea and Laser Eye Institute – Hersh Vision Group, in Teaneck, NJ, most people don’t have lasting side effects and do very well with the surgery.

“There has been an enormous amount of progress in technology since the first days of LASIK,” he says. “I’m concerned that [the FDA’s guidance] might have been based on old data with very little current peer-reviewed literature supporting it and that it shows lack of balance.”

For example, something not mentioned by the FDA is the more sophisticated technologies that have replaced the simple programs that were used in the past, says Hersh, who was a lead author of the clinical study that led to the very first FDA approval of laser therapy in the treatment of nearsightedness in the United States in 1995. 

How Does LASIK Work?

There are different types of laser procedures.

“In LASIK, the first step is to create a flap using a device called a microkeratome and then a laser to reshape the cornea, which is like the clear dome of a watch. After that, the flap is replaced and the patient takes antibiotics and anti-inflammatory medications,” says Hersh.

In another procedure, PRK (photorefractive keratectomy), the surface layer of the cornea (epithelium) is removed, like removing tiles from the floor, Hersh explains. It’s done directly on the surface of the cornea. And after that, “a therapeutic contact lens (a kind of bandage) is placed over the cornea to support the surface healing of epithelial cells and give greater comfort.”

Occasionally, the SMILE (small incision lenticule extraction) technique might be used. This involves reshaping the cornea by removing a lenticule (small lens) from the central corneal layer. 

“Nowadays, about 75% of procedures are LASIK and about 25% are PRK, depending on what’s best for the patient,” says Hersh, a clinical professor of ophthalmology and director of the Cornea and Refractive Surgery Division at Rutgers Medical School.

Data from the patient’s exam is programmed into the laser, so the procedure is highly personalized – representing a great advance over the programs that were used to guide the procedure decades ago.

Who’s a Good Candidate?

According to Hersh, people who might benefit the most from LASIK are:

  • People with healthy eyes who want to depend on glasses and contact lenses less (perhaps because of an active or sport-oriented lifestyle)
  • People who are intolerant of glasses or contact lenses
  • People with prescription eyeglasses who still don’t get their best vision 

“Some of the things we look for are making sure the cornea is smooth, with no pathology, scarring or infection, and making sure the person does not have severe dry eye,” he says. He also looks at the patient’s family history to see if there are other health problems that might come up. 

Daniel Laroche, MD, an assistant professor of ophthalmology at Mount Sinai School of Medicine in New York City, says people with certain immune diseases, diabetes, eye conditions (like glaucoma or cataracts), or other health conditions may not be good candidates for LASIK.

Your ophthalmologist should have a complete picture of your overall health, he advises.

Risks and Side Effects

Side effects of LASIK include red eyes, blurred vision, dry eyes, and sometimes even reduced vision, says Laroche. “The vast majority of people – around 95% – do well, but about 1% to 5% have complications,” mostly short-term but sometimes long-term. 

Longer-term complications include the chance that the flap created during LASIK might not heal properly, and the possible loss of corneal strength, Laroche says. And having had LASIK might complicate cataract surgery if you need it in the future.

Laroche, also director of glaucoma services and president of Advanced Eyecare of New York, no longer performs LASIK, concentrating mostly on glaucoma treatment, including surgery. He warned that having LASIK can “give artificially low pressure readings” during eye exams. 

Since high pressure in the eye is an important warning sign for glaucoma (an eye condition that can cause vision loss or blindness), it’s critical to let ophthalmologists know that you’ve had LASIK. “I’ve had patients go blind from glaucoma because the diagnosis was missed,” he says.

Hersh notes that in a small percentage of people, vision doesn’t improve as much as they would like after the surgery, so they may need to have another treatment, typically 3 to 6 months later to “tune it up, so to speak, to bring it from the 6-yard line to the 3-yard line.” 

Dry eye and irritation tend to get better over time in most patients, although a handful go on to longer-term dry eye, Hersh notes. Typically, visual effects like glare, halo, and trouble with night driving ease soon after the procedure; indeed, many patients have better vision at night than they did with their glasses or contact lenses. And LASIK won’t prevent the need for reading glasses.

“It’s important to have realistic expectations,” he says. 

Hersh and Laroche emphasize that your best chance for successful LASIK is in going to an ophthalmologist who specializes in these kinds of procedures, does thorough and appropriate testing, and goes through a proper informed consent process so you know the risks and benefits of the procedure and what to expect.

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