OPHTHALMOLOGY COMMUNITY GIVES FDA SIDE-EYE

Informed consent proposal would require surgeons to provide LASIK patients with specific detail about risks.

BY JOSEPH F. JALKIEWICZ, CONTRIBUTING EDITOR

The AAO and other ophthalmology groups are fighting proposed FDA guidance that would require surgeons to inform their LASIK patients in greater detail about the risks of the popular procedure.

Published in July 2022, the FDA’s proposed LASIK Lasers – Patient Labeling Recommendations Draft Guidance calls for surgeons to go over a detailed checklist of potential side effects and their incidences with patients considering LASIK. It also would require laser technology manufacturers to update their product labeling with more explicit language related to LASIK risks.

Advisories requested by the FDA include warnings that after 6 months up to 27% of patients experience dry eye; 41% may experience glare, halos, starbursts or double vision; and 2% may experience difficulty seeing without wearing eyeglasses or contacts. In addition, the FDA wants patients informed that, after 5 years, some 15% of patients still require drops for dry eye; almost 10% experience trouble with nighttime driving; and about 1% report severe, constant pain.

THE OPHTHALMOLOGY COMMUNITY’S TAKE

The ophthalmology community has made it clear where it stands on the FDA’s proposal. While the AAO says it appreciates and supports the intent of the FDA’s draft guidance toward patient safety, “we don’t believe that, in its current form, this document serves that end well,” says AAO Chief Executive Officer Stephen D. McLeod, MD, in a recent statement.

“Much of the content presented is important for the informed consent process, but it is presented with insufficient depth and nuance,” he adds. “Risks and benefits do not exist in a vacuum, and for them to be meaningful rather than abstract, they must be interpreted and discussed in the context of a specific patient.”

In a written response to the FDA, ASCRS Executive Director Steve Speares says “ASCRS agrees that patients should be presented with the facts about the benefits and risks of LASIK eye surgery, but it must be done in a balanced manner based on scientifically valid data. Therefore, we urge the FDA to withdraw the LASIK Lasers – Patient Labeling Recommendations Draft Guidance and work closely with ASCRS and other ophthalmic societies to reexamine current patient materials and identify opportunities to improve patient education about LASIK procedures.”

Individual ophthalmologists are also pushing back against the FDA’s recommendations.

“The FDA is potentially crossing a line with respect to its responsibility and jurisdiction,” says Robert J. Weinstock, MD, director of cataract and refractive Surgery at The Eye Institute of West Florida and the Weinstock Laser Eye Center in Tampa Bay. Dr. Weinstock calls the agency’s proposal a “Pandora’s box” that, if opened, could lead to expanded FDA influence over matters not within its purview.

“It’s not the FDA’s role to be involved in a patient’s decision-making process whether to get surgery or not,” Dr. Weinstock says. “The FDA is simply a governing body to approve procedures, which it did for LASIK. The consent process is something that needs to be in the hands of the surgeon, between the doctor and the patient, not a government agency.”

Sidney Gicheru, MD, a laser and cataract surgery specialist with Lasercare Eye Center in Dallas, expresses concern that the FDA is basing its guidance in part on faulty data — namely, early studies linking pupil size to increased post-LASIK risks of night vision disturbances.

“It was an idea we had in the early 2000s, but there have been many subsequent studies that show [pupil size] is not medically relevant,” Dr. Gicheru says. “We believe in evidence-based medicine. If they’re going to put out guidance, then the guidance really needs to be evidence based.”

He also argued that much of the FDA guidance is already addressed as part of the informed consent process.

“What they’re requesting would basically duplicate the efforts that nearly all of us are already doing in terms of educating the patients,” he says. “We want patients to be educated just like the FDA does, but we don’t want our efforts being duplicated, and we just don’t want a lot of bureaucracy.”

The FDA was still finalizing the guidance, and a deadline for implementation had not been set as of early January. OM