Lasik patients should be warned of complications, US FDA draft says

More than half a million Americans undergo Lasik surgery each year, hoping to remedy poor eyesight. PHOTO: NYTIMES

WASHINGTON – Patients considering Lasik surgery should be warned that they may be left with double vision, dry eyes, difficulty driving at night and, in rare cases, persistent eye pain, according to draft guidance by the Food and Drug Administration (FDA).

After surgery, patients might still need eyeglasses, the document warns.

If put into effect, the agency’s warnings are likely to come as a surprise to many Americans, who view the procedure as safe and commonplace. Every year, more than half a million adults undergo Lasik surgery to correct poor vision.

The operation involves reshaping the cornea, the clear round dome that covers the front of the eye and focuses light on the retina at the back of the eye. The surgeon cuts a thin flap in the cornea and folds it back, and then uses the laser to sculpt the cornea. Afterward, the surgeon replaces the flap.

The operation normally takes less than 15 minutes per eye, and patients usually must pay thousands of dollars out of pocket, since the procedure is not covered by insurance and is considered cosmetic. Lasik surgeons, who point to surveys showing that 90 per cent to 95 per cent of customers are satisfied, often promote the procedure by offering free consultations and steep discounts.

The FDA document is not final. More than 600 individuals and professional groups have weighed in with comments since the draft of the guidance was made public in July, and the agency is now reviewing the input while preparing the final documents, officials said.

‘All we’re asking is balance’

Organisations representing surgeons and medical device manufacturers have gone on the offensive, accusing the FDA of meddling in the practice of medicine and saying the information is one-sided and will needlessly frighten patients.

Many ophthalmologists say Lasik is the safest procedure done on the eye and that serious, long-lasting complications are rare.

“All we’re asking for is balance,” said Dr Vance Thompson, incoming vice-president of the American Society of Cataract and Refractive Surgery. “This document mainly emphasises the dangers and complications of Lasik, with no mention of the advantages, and the tone is negative enough that it will scare patients.”

He noted that over 90 per cent of patients in the FDA’s own studies expressed satisfaction with the results because they “are achieving good vision without spectacles, which is the goal of most patients”.

But according to the FDA’s draft guidance, a few Lasik patients have become severely depressed, even considering suicide, after experiencing complications from the surgery. Certain chronic conditions, like diabetes, and some medications may put patients at risk for poor outcomes, the document says.

The FDA guidance has been in the making for over a decade. The document states briefly that the surgery is done to reduce dependency on eyeglasses, but most of the 29-page draft guidance is about the risks.

While surgeons and device manufacturers are calling for the draft to be withdrawn in its entirety, critics of the procedure say the focus on risks is appropriate, since the procedure is performed on healthy eyes, not to treat an illness.

“I’ve been waiting 14 years for this to happen,” said Ms Paula Cofer, a Florida woman who testified before the FDA in 2008 and in 2018 that Lasik surgery ruined her eyesight and left her with chronic pain.

The new warnings would provide critical information for consumers, she added: “Right now, even if patients do research on the Internet and see warnings, they think it’s just one or two unhappy people. Now, they see it’s the FDA saying this.”

A ‘decision checklist’

The FDA is proposing a patient “decision checklist” that describes Lasik surgery, noting that corneal tissue is “vaporised” and that corneal nerves “may not fully recover” from the incisions, “resulting in dry eyes and/or chronic pain”.

Even after healing, the draft says, the cornea will never be as strong as it was before the surgery.

In comments to the agency, some patients said they had life-altering complications and vision loss, while others raved about their results.

The professional organisation representing optometrists, who perform vision tests and prescribe eyeglasses and contact lenses, praised the draft and recommended adding even more precautions about Lasik surgery for pregnant patients and those with irregular astigmatism.

The agency’s draft draws on the 2017 findings of a study on patients’ outcomes with Lasik, a collaboration between the FDA and the National Eye Institute and the Department of Defence. It assessed visual symptoms before and after Lasik. The FDA also performed its own meta-analysis of peer-reviewed studies published between 2013 and 2018.

The first study found that three months after Lasik surgery, nearly half of patients who had no visual symptoms before the procedure had developed a new visual aberration for the first time, most commonly halos, which are starburst shapes around lights. Close to one-third reported dry eyes at three months.

The study’s authors wrote that “patients undergoing Lasik surgery should be adequately counselled about the possibility of developing new visual symptoms after surgery before undergoing this elective procedure”.

Still, more than 90 per cent of patients said they were satisfied with the outcome.

The agency has conducted its own analysis, finding that six months after surgery, 27 per cent of patients experienced dry eyes and 2 per cent had difficulties that prevented them from engaging in their usual daily activities.

Five years after surgery, according to the FDA, 17 per cent of patients still relied on eye drops, 2 per cent continued to experience visual disturbances and 8 per cent still had difficulty driving at night. NYTIMES

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