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LASIK
Eye Surgery Information to help the
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Today's results are probably better than FDA data. By
definition, FDA trials occur during the early period of a
laser's life cycle. Manufacturers are allowed to and often do
make technical improvements to the instruments, sometimes even
while the lasers are still under investigation. This, together
with increasing surgeon experience over time, means that results
in actual clinical practice are often better than the initial
FDA data.
FDA data in one study cannot fairly be compared to FDA data
in another study. Manufacturers go to the FDA with various study
designs, which often have differing endpoints and
patient-enrollment criteria. Although all studies must answer
certain basic questions regarding safety and effectiveness, they
are not designed to be compared with one another. A true
comparison of Laser A and Laser B would require randomized
clinical trials (RCTs), in which patients would be randomly
assigned to receive surgery by one laser or the other over the
same time period by the same surgeons. FDA trials don't do that,
although other studies sometimes do.
Studies don't cover every possibility. Just because you have
a characteristic or condition that is not covered by the
approved labeling of a laser doesn't mean that the laser won't
work for people with your characteristic or condition. Neither
does it mean that another laser approved to treat people with
your characteristic will do a better job. Remember, these
studies have differing designs, and people with your
characteristic or condition may or may not have been included,
or their results may or may not have been analyzed, or there may
have been too few such people in the studies to determine
statistical or clinical significance.
Once the FDA approves a laser, your surgeon can use it any way he or she deems appropriate. This is true of all FDA-approved drugs and devices. This is commonly referred to as "off-label" use of an FDA-approved drug, device, or laser. It's called a physician's practice-of-medicine prerogative, and there's nothing inherently wrong with it. In medicine, doctors often use one technology for a patient with a condition that was not in the FDA clinical trial. The use of that equipment in this regard is called "off-label," while characteristics included in the FDA study are "on-label." A common example of off-label use is a doctor recommending aspirin to reduce the risk of stroke, although aspirin originally was FDA approved for pain relief.
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