Patients who are considering correcting myopia, hyperopia, or astigmatism with keratosculpture with laser (LASIK), they should be properly informed about the benefits and potential risks of the operation.

They also need to know that the decision on whether they are suitable candidates for surgery is made based on specific objective criteria and not on a whim.

An American reports Food and Drug Administration (FDA), who held months-long public consultations about the warnings that will henceforth accompany LASIK surgery. The consultation was completed at the end of November and the final text with its conclusions is currently awaited.

The FDA’s warnings may come as a surprise to patients, as LASIK has been the most popular refractive surgery performed for three decades, while it’s usually marketed as a safe routine procedure. Hundreds of thousands of laser keratoplasty surgeries are performed worldwide every year. in the US they are over 500,000 and in the UK they are over 100,000.

The success of these operations reaches 99% according to the American Council for Refractive Surgery (ARSC). However, 90% of patients achieve perfect vision (20/20): the rest need to continue to wear corrective glasses and/or contact lenses. In addition, some (up to 2%) require a second operation to achieve the desired result.

But the most important thing is that nothing in medicine is absolutely safe. Although LASIK one of the safest operations in some cases has complications of varying severity. According to the FDA, its potential complications include diplopia (the patient sees a double image), dry eyes, difficulty driving at night, and, in very rare cases, persistent eye pain. There is also a chance of seeing an infection or swelling in the eye (probability is about 1 in 5,000).

In addition, the FDA notes that certain chronic conditions, such as diabetes and certain medications, may put patients at risk for poor outcomes. It also states that corneal nerves “may not fully recover” after surgery, “resulting in dry eyes and/or chronic pain.” However, even after healing, the cornea may not be as strong as before, he adds.

But what prompted the FDA to hold a public consultation on a procedure that has been in place since 1989? “In the US, LASIK is heavily advertised, but without informing the general public that it is an eye surgery with very low risk but some rare complications,” he replies. Dr. Anastasios I. Kanellopoulos, MD, ophthalmic surgeon, founder and scientific director of the LaserVision Institute of Ophthalmology, professor of ophthalmology at New York University. “Furthermore, it is not specified that the technology used also matters. This has changed drastically over time, and with the latest generation of lasers and state-of-the-art technology, side effects such as some of the night vision or quality of vision problems we experienced with older technologies have been nearly eliminated. .”

The FDA study is also likely due to the fact that LASIK is done all the time. more accessible and applies to all more people. And this despite the fact that for most of them this is an optional operation, and not a treatment that is carried out in connection with an acute medical need.

Despite this, “when someone objectively evaluates surgery, in addition to the benefits and possible complications, he must also take into account existing alternative solutions,” emphasizes Mr. Kanellopoulos. “An alternative to LASIK is that the patient continues to wear contact lenses or glasses. However, continued contact lens use carries a significant risk of corneal infections, which may even require a corneal transplant to correct.”

In fact, “1 in 1,000 daily contact lens wearers develop long-term severe keratitis, which is far more damaging to vision than laser refractive surgery like LASIK,” he adds.

Moreover, many people cannot continue to wear corrective glasses or contact lenses for professional, personal reasons (eg sports, hobbies) or simply because these media do not take into account their quality of vision.

The LASIK operation is performed without a scalpel, with using two different lasers. One is called a femtosecond laser and is used to separate the top layer of the cornea from the surface of the eye.

The second is an excimer laser, with which the doctor models the underlying layer of the cornea. When modeling is complete, it replaces the top layer, leaving the surface of the eye almost untouched.

Corneal sculpting improves light focusing on the retina at the back of the eye. Thus, vision is restored to a large extent. The entire procedure usually takes less than 20 minutes for each eye.

Most people are suitable candidates for surgery suffering from myopia, farsightedness or astigmatism, But not all. The selection of each patient is made individually based on certain criteria, which, according to Mr. Kanellopoulos, include:

• Age (patient must be over 18)
• Stabilization of vision (must have stable vision and refraction for at least 1 year)
• General eye health (other eye problems should not co-exist)
• Certain characteristics of the cornea (for example, the relative limitation of LASIK if the cornea is very thin).

“Our research team in Athens has worked for many years to continuously improve the LASIK technique. He has been a pioneer in the use of the femtosecond laser since 2006, has introduced personalized sculpture with topography and recently with ray tracing worldwide, and conducts educational sessions for ophthalmologists in Europe and the US in the context of three major international conferences in ophthalmology. (European and American Academy of Ophthalmology, as well as the American Society of Refractive Surgeons),” says Mr. Kanellopoulos. “Properly informing patients about the benefits of such an intervention and the possible risks it entails is an important part of our methodology. Moreover, most risks can be avoided with careful preoperative evaluation of each individual case.”