Lasik’s Risks Are Coming Into Sharper Focus

Roni Caryn Rabin, New York Times: June 11, 2018


Ever since he had Lasik surgery two years ago, Geobanni Ramirez sees everything in triplicate.

The surgery he hoped would improve his vision left the 33-year-old graphic artist struggling with extreme light sensitivity, double vision and visual distortions that create halos around bright objects and turn headlights into blinding starbursts.

His eyes are so dry and sore that he puts drops in every half-hour; sometimes they burn “like when you’re chopping onions.” His night vision is so poor that going out after dark is treacherous.

But Mr. Ramirez says that as far as his surgeon is concerned, he is a success story.

“My vision is considered 20/20, because I see the A’s, B’s and C’s all the way down the chart,” said Mr. Ramirez. “But I see three A’s, three B’s, three C’s.”

None of the surgeons he consulted ever warned him he could sustain permanent damage following Lasik, he added.

The Food and Drug Administration approved the first lasers to correct vision in the 1990s. Roughly 9.5 million Americans have had laser eye surgery, lured by the promise of a quick fix ridding them of nettlesome glasses and contact lenses.

There is also a wide perception among patients, fostered by many eye doctors who do the surgery, that the procedure is virtually foolproof.

As far back as 2008, however, patients who had received Lasik and their families testified at an F.D.A. meeting about impaired vision and chronic pain that led to job loss and disability, social isolation, depression — and even suicides.

Even now, serious questions remain about both the short- and long-term risks and the complications of this increasingly common procedure.

recent clinical trial by the F.D.A. suggests that the complications experienced by Mr. Ramirez are not uncommon.

Nearly half of all people who had healthy eyes before Lasik developed visual aberrations for the first time after the procedure, the trial found. Nearly one-third developed dry eyes, a complication that can cause serious discomfort, for the first time.

The 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.”

Lack of precise information about complications is a problem that plagues many medical devices, which are tested by manufacturers and often gain F.D.A. approval before long-term outcomes are known, said Diana Zuckerman, president of the nonprofit National Center for Health Research in Washington.

“The F.D.A. keeps promising to do a better job of post-market surveillance, but there is no evidence of real improvement,” she said.

Many ophthalmologists insist Lasik is the safest procedure done on the eye — some say the safest medical procedure, period — and serious complications are “exceedingly rare.” […]

Read the original article here.