A draft guidance by the US Food and Drug Administration (FDA) said that patients considering Lasik to correct their vision should be warned that they may be left with double vision, dry eyes, difficulty driving at night, and in rare cases, persistent eye pain. The document warns that patients may still need eyeglasses after Lasik or laser eye surgery.
More than 600 individuals and professional groups have added their comments since the draft of the guidance was made public in July. The agency is now reviewing the input while preparing the final documents for wider implementation.
The correction of poor vision via Lasik or laser eye surgery is widely perceived as safe and commonplace. According to data compiled by London-headquartered Focus Clinics, 30 million people in the world are successfully treated with laser eye surgery.
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 an overwhelming majority (about 90 per cent) showed satisfaction with 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.
Why the U.S. FDA wants to warn patients before Lasik surgery?
The draft document draws its authority from the 2017 findings of a study on patients’ outcomes with Lasik. The study was conducted together by the US FDA and the National Eye Institute and the Department of Defense. 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 draft document says.
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 counseled about the possibility of developing new visual symptoms after surgery before undergoing this elective procedure.”
However, more than 90 per cent of patients said they were satisfied with the outcome.
The agency in its own analysis found 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.
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