- The FDA is considering a new policy requiring health providers to warn patients about the potential side effects of getting LASIK.
- These warnings would include information on the risks of double vision, dry eyes, ongoing pain, and other issues from the surgery.
- LASIK works by changing the shape of the cornea to improve vision by correcting nearsightedness, farsightedness, or astigmatism.
LASIK is the most commonly performed laser refractive surgery in the United States, used to correct common vision problems.
These warnings would include information on the risks of double vision, dry eyes, ongoing pain, and other issues from the surgery. Patients would also be advised that they may still need glasses even after the surgery.
“The FDA is currently interested in physicians providing patients with a written warning prior to LASIK surgery,” said Dr. Mark Fromer, an ophthalmologist from Lenox Hill Hospital in New York. “LASIK surgery has been available to patients for vision correction for 28 years in the United States. It remains one of the safest ocular procedures performed.”
If you’re considering having a LASIK procedure, here is everything you need to know about LASIK and the new FDA warning.
Approximately 64% of Americans wear prescription eyeglasses, according to The Vision Council.
LASIK is a laser refractive surgery that was designed to correct impaired vision. It works by changing the shape of the cornea to improve vision by correcting nearsightedness, farsightedness, or astigmatism. About 10 million people have gotten LASIK in the United States since it was approved by the FDA in 1999.
It has a high success rate and improves vision to 20/20 in more than 90% of people.
While the success rate of LASIK is high, the FDA’s draft warning covers the potential negative side effects of the surgery.
It covers the potential for a variety of negative outcomes from the surgery, like double vision, dry eyes, poor vision at night, and even pain. The document goes so far as to say that there have been reports that patients who have had LASIK experience depression or become suicidal following complications from the procedure.
More than 600 experts and expert groups have been consulted for the document, which has not been finalized yet. The warning calls for a checklist of information for the patient to review prior to surgery.
The prospective checklist is being designed by the FDA to recognize proper patient selection to ensure the best outcomes for LASIK. It is emphasizing that there are patients who may not be the optimal candidates for the procedure. The proposed checklist, which is not finalized, lists certain medical conditions, which patients are meant to read through to determine if they are good candidates for the procedure.
For each characteristic or condition, the FDA provides a warning that details if a patient should or should not get the procedure based on that condition. For example, if a patient checks “Severe Dry Eyes,” they are warned that LASIK should not be considered. If they have moderate or mild dry eyes, they are warned to consider not having LASIK.
If the document is approved, some of the characteristics that the FDA might deem unsafe for LASIK include:
- Cornea not thick enough
- Eye inflammation
- Active autoimmune or connective tissue disease
- Uncontrolled glaucoma
- Uncontrolled diabetes
Many ophthalmologists say that LASIK is one of the safest procedures on the market and that complications are rare. Experts say that the FDA document may be one-sided, listing only the negative outcomes without mentioning enough about the positive outcomes.
“All we’re asking for is balance,” Dr. Vance Thompson, incoming vice president of the American Society of Cataract and Refractive Surgery told The New York Times. “This document mainly emphasizes the dangers and complications of LASIK, with no mention of the advantages, and the tone is negative enough that it will scare patients.”
Other experts believe the document is designed to ensure that they understand the risks of elective surgery. It’s an expensive surgery, as well, costing typically thousands of dollars and is not covered by insurance. Ensuring patients have all the information is the goal.
“The risks have not changed dramatically over the decades that laser vision has been performed by physicians,” said Fromer. “Patients understanding the risks, benefits, and alternatives of surgery must be clear to all patients prior to undergoing surgery. It is the belief of the FDA that in the last 15 years, further information regarding risks has been gathered that should be reported to potential patients.”
Fromer adds that the FDA is concerned that patients are not receiving information that is understandable in layman terms to help them make an informed decision.
“[The checklist] is ultimately an important tool to help standardize the information patients receive and to ensure that both the patient and physician have a shared understanding of the ultimate goals and potential risks of this elective procedure,” said Fromer.