"The groundwork of all happiness is health." - Leigh Hunt

What the FDA's submission means for the risks and advantages of LASIK

January 17, 2023 – Two years ago, Benjamin Wilbur underwent LASIK surgery to correct his vision. “I have three relatively young children and I felt like I was constantly being hit in the face and my glasses were being knocked askew,” he says. He also didn't just like the indisputable fact that his glasses “fogged up” when he wore a mask throughout the pandemic.

After a 10-minute consultation with an ophthalmologist, Wilbur, 37, a pharmaceutical researcher based in New Jersey, was deemed an acceptable candidate. After the procedure, he suffered from dry eyes for a couple of weeks, which he treated with artificial tears. Within 6 weeks, he now not needed them.

“I was able to drive again within 24 hours and my vision was fine,” he says. “I went for regular check-ups and had the last one three months ago – my vision was 20/15.”

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

LASIK stands for laser-assisted in situ keratomileusis and is a procedure that uses laser technology to permanently change the form of the cornea (the clear covering on the front of the attention). LASIK is incredibly popular, with over 500,000 adults within the United States undergoing the procedure. But the FDA has recently begun to make clear the risks of the procedure.

And while most LASIK patients have experiences like Wilbur, last yr the FDA Draft guidelines published for recommendations that doctors warn patients concerning the risks. The agency has asked patients and doctors for his or her opinions and has not yet issued a final report. The proposed guidelines call for warnings about double vision, dry eyes, persistent pain and other problems. It even says that patients should still need glasses after surgery.

Lorrie Shank Tevebaugh, a TexanThe 53-year-old, who works in human resources, is a former LASIK patient and is amongst those that have had bad experiences with LASIK. Tevebaugh decided to have the surgery because she is “an avid hiker and runner and spends a lot of time on the boat” and desired to do those activities without glasses.

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

But the subsequent day, her vision was still blurry and he or she was experiencing eye pain. At her visit 24 hours after surgery, she was assured that her eyes would proceed to enhance over the subsequent three days. Instead, her vision continued to deteriorate.

The following week she could now not see anything except shapes and colours. One of her eyes was swollen shut and he or she was in pain. She was diagnosed with central nervous system. toxic keratopathya rare complication.

Almost a yr after the operation, Tevebaugh continues to be battling the damage. Her cornea is flattened. She wears special contact lenses that require a special liquid solution, in addition to bifocals. She regrets the procedure. “If I had heard about it beforehand, I wouldn't have done it.”

The influence of the FDA

According to Dr. Peter Hersh, director of the Cornea and Laser Eye Institute – Hersh Vision Group in Teaneck, New Jersey, most patients experience no lasting negative effects and the procedure could be very well tolerated.

“There have been tremendous technological advances since the early days of LASIK,” he says. “I am concerned that [the FDA’s guidance] may be based on old data supported by very little recent peer-reviewed literature and lacks balance.”

For example, the FDA didn't mention that the straightforward programs previously used have been replaced by more sophisticated technologies, says Hersh, considered one of the lead authors of the the clinical study This led to the first-ever FDA approval of laser therapy for the treatment of myopia within the United States in 1995.

How does LASIK work?

There are several types of laser treatments.

“With LASIK, the first step was to create a flap using a mechanical device called a microkeratome and then use a laser to reshape the cornea. You can think of it as removing a 'tissue contact lens.' After that, the flap is put back in and the patient takes antibiotics and anti-inflammatory medications,” says Hersh.

But today's procedures are more advanced and safer, notes Hersh. A microkeratome isn't used anymore. One of the innovations within the procedure is using a laser as a substitute of a microkeratome to organize the LASIK flap. This makes the flap rather more uniform in size and thickness and much less vulnerable to surgical complications.

Another procedure, PRK (photorefractive keratectomy), involves removing the surface layer of the cornea (epithelium), like removing tiles from a floor, Hersh explains. This is finished directly on the surface of the cornea. And afterward, “a therapeutic contact lens (a type of bandage) is placed over the cornea to help the surface healing of the epithelial cells and provide more comfort.”

Occasionally, the SMILE (Small Incision Lenticule Extraction) technique could also be used. This involves reshaping the cornea by removing a lenticule (small lens) from the central layer of the cornea.

“Today, about 75% of procedures are LASIK and about 25% are PRK, depending on what is best for the patient,” says Hersh, a Clinical Professor of Ophthalmology and Director of the Division of Corneal and Refractive Surgery at Rutgers Medical School.

Because data from the patient's examination is programmed into the laser, the procedure is incredibly personalized, a serious advance over the programs that controlled the procedure many years ago.

Who is candidate?

According to Hersh, the next people profit most from LASIK:

  • People with healthy eyes who wish to be less depending on glasses and call lenses (for instance resulting from an lively or sporty lifestyle)
  • People with an intolerance to glasses or contact lenses
  • People who wear glasses but still cannot see optimally

“Among other things, we check to make sure the cornea is smooth and free of pathologies, scars or infections, and that the person does not suffer from severe dry eyes,” he says. He also examines the patient's family history to find out if there could also be other health problems.

Daniel Laroche, MD, Assistant Professor of Ophthalmology at Mount Sinai School of Medicine in New York Citysays that individuals with certain immune disorders, diabetes, eye diseases (akin to glaucoma or cataracts), or other health conditions will not be good candidates for LASIK.

Your eye doctor should get a comprehensive picture of your general health, he advises.

Risks and negative effects

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

Longer-term complications include the chance that the flap created during LASIK won't heal properly and the possible lack of corneal strength, Laroche says. And LASIK treatment could make cataract surgery tougher if you happen to need it in the longer term.

Laroche, who can be chief of the glaucoma division and president of Advanced Eyecare of New York, now not performs LASIK surgery and focuses totally on glaucoma treatment, including surgery. He warned that LASIK “can result in artificially low pressure readings” during eye exams.

Because increased eye pressure is a serious warning sign of glaucoma (an eye fixed disease that may result in vision loss or blindness), it's essential to inform your eye doctor about LASIK surgery. “I've had patients who went blind from glaucoma because it wasn't diagnosed,” he says.

Hersh points out that a small percentage of patients don't see their vision improve as much as they would really like after surgery, in order that they may have further treatment, normally after three to 6 months, to “tweak it, so to speak, and get it from the 6-yard line to the 3-yard line.”

Dry eyes and irritation improve over time for many patients, although some patients experience dry eyes for longer, Hersh notes. Typically, visual effects akin to glare, halos and difficulty driving at night improve soon after the procedure; in actual fact, many patients have higher nighttime vision than with glasses or contact lenses. And LASIK doesn't eliminate the necessity for reading glasses.

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

Hersh and Laroche emphasize that your best likelihood of success with LASIK treatment is with an eye fixed doctor who makes a speciality of any such procedure, performs thorough and appropriate testing, and follows a correct consent process in order that you recognize the risks and advantages of the procedure and what to anticipate.