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What FDA Entry Means for the Risks and Benefits of LASIK

January. Jan. 17, 2023 — Two years ago, Benjamin Wilbur had LASIK surgery to correct his vision. “I have three young children and I feel like I’ve been punched in the face a lot and my glasses have been knocked askew,” he said. He also doesn’t like the “fogging” of wearing a mask and glasses during the epidemic.

After a 10-minute consultation with an ophthalmologist, Wilbur, a 37-year-old New Jersey pharmacy investigator, Considered a good candidate. For weeks after surgery, his eyes remained dry, which he treated with artificial tears. Within 6 weeks, he no longer needed them.

“I can drive within 24 hours and I have good eyesight,” he said. “I went back for regular checkups, last was 3 months ago – my vision is 20/15.”

Wilbur is pleased with the results. “I wish I had done it sooner,” he said Permanently changes the shape of the cornea (the transparent covering at the front of the eye) using a specific type of laser technology. LASIK is so popular that more than 500,000 American adults have had the procedure. But the U.S. Food and Drug Administration recently began clarifying its risks.

While most LASIK patients have experiences like Wilbur’s, FDA issued guidelines last year Draft for advice from physicians to warn patients of risks. The agency has solicited input from patients and doctors but has not released a final report. The proposed guidelines push for warnings about double vision, dry eyes, persistent pain and other problems. It even says people may still need glasses after surgery. 53 years old, working in HR, former LASIK patient, had a bad experience with LASIK surgery. Tevebaugh decided to have the surgery because she’s an “avid hiker and runner and spends a lot of time on boats” and wanted to do those activities without glasses.

She went to a reputable ophthalmologist and was told she was an ideal candidate for LASIK. “The surgery itself went very well,” she said.

But the next day her vision was still blurred and she started to have eye pain. At her 24-hour post-op visit, she was assured her eyes would continue to improve over the next 3 days. Instead, her vision continued to deteriorate.

By the next week she couldn’t see anything but shapes and colours. One of her eyes was swollen shut and she was in pain. She was diagnosed with central toxic keratopathy , a rare complication disease.

Nearly a year after surgery, Tevebaugh is still battling the injury. Her cornea flattened. She wears special contact lenses that require a special liquid solution and bifocal lenses. She regrets having the surgery. “If I had heard of this in advance, I wouldn’t have done it.”

FDA Impact

According to Peter Hersh, MD, Director of the Corneal and Laser Eye Institute – Hersh Vision Group in Teaneck, NJ, most people have no lasting side effects and very little surgical progression smoothly.

LASIK,” he said. There is currently little peer-reviewed literature supporting it, and it shows a lack of balance. “

For example, what the FDA does not mention is that more complex technology has replaced the simpler procedures used in the past, said Hersh, who is Clinical studies led to the FDA’s first approval of laser therapy for myopia in the United States in 1995.

How does LASIK work?

There are different types of laser programs.

“In LASIK, the first step is usually to create a flap of the cornea using a mechanical device called a microkeratome, and then a laser is used to reshape the cornea, which can be Considered the removal of “tissue contact lenses”. The flap was then replaced and the patient was given antibiotics and anti-inflammatory medication,” Hersh said.

    But Hersh points out that today’s procedures are more advanced and safer. Microkeratome is rarely used. Instead, One of the procedure’s innovations is the use of a laser instead of a microkeratome to prepare the LASIK flap. This results in a more consistent flap size and thickness and is less prone to surgical complications.

    exist In another procedure, PRK (photorefractive keratectomy) removes the top layer of the cornea (the epithelium), like removing a tile from a floor, Hersh explained. It’s done directly on the surface of the cornea. Afterwards, “the treatment A contact lens (a type of bandage) is placed over the cornea to support the epithelial surface in healing and provide greater comfort. “

    Sometimes, the SMILE (Small Incision Microlens Extraction) technique may be used. This involves Reshape the cornea by removing a lenticule (lenslet) from the central corneal layer.

    ” Today, about 75 percent of procedures are LASIK and about 25 percent are PRK, depending on what’s best for the patient,” said Hersh, author of Rutgers Medicine Clinical Professor of Ophthalmology and Director of the Division of Corneal and Refractive Surgery at the Academy.

    Data from patient exams are programmed into the laser, so the procedure is highly individualized – representing a substantial improvement over previous procedures used to guide procedures decades ago.

    Who is the right candidate?

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

      People with healthy eyes wish to reduce Dependence on glasses and contact lenses (possibly due to active or exercise-oriented lifestyle)

    • People who cannot wear glasses or contact lenses
        People who wear prescription glasses still don’t get their best vision

        “Some of the things we look for are making sure the cornea is smooth, there’s no pathology, scarring or infection, and making sure the person doesn’t have severe dry eye,” he said. He also looks at the patient’s family History to see if there are other possible health problems.

        Daniel Laroche, MD, NYC Assistant Professor of Ophthalmology, Mount Sinai School of Medicine , Individuals with certain immune disorders, diabetes, eye disorders (such as glaucoma or cataracts), or other medical conditions may not be suitable LASIK.

        He advises that your ophthalmologist should have a complete picture of your overall health.


        LASIK side effects include eye redness, blurred vision, dry eyes, and sometimes vision loss, Laroche said. “The vast majority — about 95 percent — are fine, but about 1 percent to 5 percent have complications,” mostly short-term, but sometimes long-term.

        Long-term complications include the possibility that the flap created during LASIK may not heal properly, and possible There is a loss of corneal strength, Laroche said. If you need LASIK in the future, it can complicate cataract surgery. Glaucoma Services Specialist and President of Advanced Eyecare New York, who no longer performs LASIK and focuses primarily on glaucoma treatment, including surgery. He warns that using the LASIK procedure can “artificially provide a low pressure reading” during an eye exam.

        due to high pressure in the eye is a major warning sign of glaucoma (a condition that can lead to vision loss or blindness) , it is important to let your ophthalmologist know that you had LASIK surgery. “I’ve had patients go blind with glaucoma because they missed the diagnosis,” he said.

        Hersh points out , in a small percentage of people, vision doesn’t improve as much as they’d like after surgery, so they may need another treatment, usually 3 to 6 months later “to adjust, so to speak, to take it from the 6 yard line Bring to 3 yard line.”

        Most patients experience dry eye and irritation with Improves over time, although a minority of patients will continue to have chronic dry eye, Hersh noted. Often, vision effects such as glare, halos, and night driving problems resolve shortly after surgery; in fact, many patients see better at night than they do with glasses or contact lenses. And LASIK won’t stop the need for reading glasses.

        ” He said.

        Hersh and Laroche emphasize that the best chance for successful LASIK surgery is to see a professional who specializes in these types of Informed consent process so you understand the risks and benefits of the process and expected outcomes.



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