Laser eye surgery comes under close scrutiny

Apr 28 2008

More and more people are having laser vision corrective surgery (LASIK surgery) in the hope that their vision will be restored to such an extent that glasses will no longer be needed.

But now experts in the U.S. are calling for the Food and Drug Administration (FDA) to warn patients about the risks of the increasingly popular operation.

The surgery involves cutting the outer layer of the cornea (epithelium) with a fine blade, alcohol is then used to loosen and lift it and a laser beam is directed at tissue under the epithelium removing just enough to reshape the cornea which corrects the vision.

An expert panel of federal health advisers has heard accounts from LASIK patients and their families about severe reactions to the surgery which included on-going vision problems, severe dry eye, severe eye pain, blurred vision, glare, an inability to drive at night and even suicide.

As a result of the hearing the FDA has launched a new national study of patient outcomes, along with the National Eye Institute and the American Society of Cataract and Refractive Surgery (ASCRS) in an attempt to compile more information on LASIK results.

The experts say the study will take years to complete so any information given to patients considering LASIK surgery should clearly warn of the possibility of long-term vision problems.

The FDA says it is concerned that doctors are not adequately informing patients about the potential risks.

Recent research suggests that 95% of all patients who undergo LASIK are satisfied with their procedure, but Dr. Jayne S. Weiss, who chaired the advisory panel says some surgeons could be doing a better job.

Experts recommend that both patient information and FDA's LASIK web site contain photos of potential vision problems so people have the opportunity to understand the risks and say more warnings are needed about the potential risks in women using hormone replacement therapy since the drugs can alter the cornea.

They have also called for more warnings for doctors who evaluate which patients may not be candidates for the procedure.

More than 700,000 U.S. patients each year have laser vision corrective surgery.