What FDA Receipt Means for Risks and Benefits of LASIK

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January 17, 2023 – Two years ago, Benjamin Wilbur had LASIK surgery to correct his vision. “I have three younger children and I felt like I was getting slapped in the face and my glasses were banging on,” he says. He also didn’t like wearing “fogged” glasses when wearing a mask during the pandemic.

After a 10-minute consultation with an ophthalmologist, Wilbur, 37, a New Jersey-based pharmacy researcher, was deemed a good candidate. After the procedure, he had dry eyes for a few weeks, 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 have returned to regular checkups and had my last 3 months ago – my eyesight was 20/15.”

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

LASIK stands for Laser Assisted In Situ Keratomileusis and was designed to permanently change the shape of the cornea (the clear covering of the front of the eye) using a specific type of laser technology. LASIK is extremely popular, with more than 500,000 US adults undergoing the procedure. But the FDA has recently begun to shed light on its risks.

And while most LASIK patients have had experiences like Wilbur’s, last year the FDA did Draft guidelines published for recommendations that doctors warn patients about the risks. The agency solicited input from patients and physicians and has yet to issue a final report. The proposed guidelines urge warnings about double vision, dry eyes, persistent pain and other problems. It is even said that people may still need glasses after surgery.

Lorrie Shank Tevebaugh, a Texas-based 53-year-old working in human resources is a former LASIK patient who is among those who have had poor LASIK experiences. Tevebaugh chose the surgery because she “is an avid hiker and runner and spends a lot of time on a boat” and wanted to be able to do these activities without glasses.

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

But the next day her vision remained blurry and she began to get eye pain. At her 24 hour post-operative visit, she was reassured that her eyes would continue to improve over the next 3 days. Instead, her eyesight continued to deteriorate.

For the following week she could see nothing but shapes and colors. One of her eyes was swollen shut and she was in pain. She was diagnosed with Central toxic keratopathya rare complication.

Almost a year after the surgery, Tevebaugh is still dealing with the damage. Your cornea is flattened. She wears special contact lenses that require a special liquid solution and bifocal glasses. She regrets the surgery. “If I had heard about it beforehand, I wouldn’t have done it.”

The impact of the FDA

According to Peter Hersh, MD, director of the Cornea and Laser Eye Institute – Hersh Vision Group, in Teaneck, NJ, most people have no lasting side effects and do very well with the surgery.

“There has been a tremendous advancement in technology since the early days of LASIK,” he says. “That worries me [the FDA’s guidance] possibly based on old data with very little recent peer-reviewed literature to support this and that it shows a lack of balance.”

For example, something the FDA doesn’t mention is the more sophisticated technologies that have replaced the simple programs used in the past, says Hersh, who was one of the lead authors of the clinical study This led to the first ever FDA approval of laser therapy to treat myopia 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 with a device called a microkeratome and then use a laser to reshape the cornea, which is like the see-through dome of a watch. After that, the valve is replaced and the patient takes antibiotics and anti-inflammatory drugs,” says Hersh.

Another procedure, called PRK (photorefractive keratectomy), removes the surface layer of the cornea (epithelium), like removing tiles from the floor, Hersh explains. It is performed directly on the corneal surface. And after that, “a therapeutic contact lens (a type of bandage) is placed over the cornea to help surface healing of the epithelial cells and provide greater comfort.”

Occasionally, the SMILE (Small Incision Lenticule Extraction) technique can be used. The cornea is reshaped by removing a lenticle (small lens) from the middle layer of the cornea.

“Today, about 75% of procedures are LASIK and about 25% are PRK, depending on what’s best for the patient,” says Hersh, MD clinical professor of ophthalmology and director of the department of corneal and refractive surgery at Rutgers Medical School.

Data from the patient’s exam is programmed into the laser, making the procedure highly personalized – a major advance over the programs used to guide the procedure decades ago.

Who is a good candidate?

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

  • People with healthy eyes who want to be less dependent on glasses and contacts (perhaps due to an active or sport-oriented lifestyle)
  • People who cannot tolerate glasses or contact lenses
  • People with prescription glasses who still don’t see at their best

“Some of the things we look for are making sure the cornea is smooth, doesn’t have any pathology, scarring or infection, and making sure the person doesn’t have severe dry eye,” he says. He also looks at the patient’s family history to see if there are other health problems that could arise.

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

Your eye doctor 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 decreased vision, Laroche says. “The vast majority of people — around 95% — are fine, but around 1% to 5% have complications,” mostly short-term but sometimes long-term.

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

Laroche, also director of glaucoma services and president of Advanced Eyecare in New York, no longer performs LASIK and focuses primarily on glaucoma treatment, including surgery. He warned that LASIK can “provide artificially low pressure readings” in eye exams.

Because high intraocular pressure is an important warning sign of glaucoma (an eye condition that can lead to vision loss or blindness), it’s important to let eye doctors know you’ve had LASIK. “I’ve had patients who went blind from glaucoma because the diagnosis was missed,” he says.

Hersh notes that a small percentage of people’s vision doesn’t improve as much as they would like after surgery, so they may need further treatment, typically 3 to 6 months later, to “sort of optimize it.” to get it from the 6 yard line to the 3 yard line.”

Dry eye and irritation get better over time in most patients, although a handful lead to longer-term dry eye, notes Hersh. Typically, visual effects such as glare, halo, and night driving problems subside shortly after the procedure; In fact, many patients have better night-time vision than they can with their glasses or contact lenses. And LASIK will not eliminate the need for reading glasses.

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

Hersh and Laroche emphasize that your best chance for a successful LASIK is to see an eye care professional who specializes in this type of procedure, conducts thorough and appropriate testing, and goes through a proper consent process so that you understand the risks and benefits of the procedure know and know what to expect.


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What FDA Receipt Means for Risks and Benefits of LASIK
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