US ophthalmologists have called for the FDA to abandon its proposed changes to patient labelling recommendations for LASIK eye surgery, which includes a “decision checklist” where patients declare their understanding of potential risks such as persistent dry eye, visual disturbances and even suicide brought about by complications.
The US Food and Drug Administration (FDA)’s ‘LASIK Lasers – Patient Labeling Recommendations Draft Guidance’ has received more than 600 submissions and stirred controversy across the ophthalmic industry.
Critics, such as the American Society of Cataract and Refractive Surgery (ASCRS), say the guidance was intended “to clearly communicate the benefits and risks of LASIK devices”, however they felt this was not the case.
“This draft guidance is highly biased and misleading to potential patients regarding the extraordinarily high success rate of LASIK surgery,” ASCRS executive director Mr Steve Speares said.
“We have considerable concerns regarding this document due to its overall tone and balance, the absence of relevant literature references, interference with the physician- patient relationship, and false and misleading statements that are not supported by valid scientific evidence.
“We urge the FDA to withdraw the [draft guidance] and work closely with ASCRS and other ophthalmic societies to re-examine current patient materials and identify opportunities that might improve patient education about LASIK procedures.”
The FDA’s proposals
With the draft guidance released in July 2022, the FDA is now reviewing input while preparing its final documents.
The agency said the recommendations were being made due to concerns that some patients were not receiving and/or understanding information regarding the benefits and risks of LASIK surgery.
Since 2008, the FDA said it had continued to gather new information pertaining to risks associated with LASIK, including dry eye, pain and discomfort, and visual symptoms.
It said it had “diligently collaborated with external experts on research efforts, including focus groups, to better characterise risks to ensure that the recommended labelling discussed in this guidance addresses the concerns uncovered in this collaboration and that risk information is communicated in an understandable format”.
“The recommendations in this guidance are being made to help ensure that patients are informed of the significant risks associated with LASIK prior to choosing this type of surgery and are informed by the latest information about these devices,” the FDA added.
In its guidance, the FDA is proposing a patient “decision checklist” that describes LASIK surgery and alternative vision correction methods. It also notes the corneal tissue is “vaporised” and that corneal nerves “may not fully recover resulting in dry eyes and/or chronic pain”.
It also outlines who might be an unsuitable candidate, including people with severe dry eyes, thin corneal tissue, diabetics and past herpes eye infection.
The check list also asks patients to consider potential long term risks, including:
- I understand that, although rare, there have been reports that some patients who have had LASIK have experienced severe depression or suicidality that they believe to be a result of complications following the procedure. A definitive causal link between LASIK and these reported psychological harms has not been established.
- I understand that dry eye may persist beyond six months.
- I acknowledge the following estimates of the percentage of patients experiencing the persistence of certain symptoms five years after surgery:
– Around 17% of patients may still need to use eye drops daily for dry eye.
– Less than 2% of patients notice some visual disturbance, such as glare, halos, starbursts, and double vision.
– A decreased ability to see under low light conditions; around 8% of patients may have moderate difficulty or a lot of difficulty driving at night.
– Very rare reports (estimated rate of less than 0.8%) of severe, constant pain that may prevent normal activities.
The ASCRS said it agreed 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,” Speares said.
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