Looking Ahead
At present, a number of other lasers for eye surgery
are currently being tested in FDA-sanctioned studies
to determine their safety and effectiveness. Investigational
Device Exemptions (IDEs) filed with FDA allow for
clinical studies involving the excimer laser and the
correction of farsightedness. The IDE process is designed
to investigate the safety and effectiveness of a device,
or a new procedure with an already approved device,
either to obtain information for publication or to
generate the data needed to obtain marketing approval
from FDA.
"If the refractive surgery center says the laser
is approved by FDA, it probably is," Waxler concludes.
"Still, it is wise for consumers to check that
the device being used for their surgery is FDA-approved,"
he says, or that they make sure they are being treated
with a laser that is under study in an FDA-sanctioned
clinical trial.
During the first few weeks immediately following laser
surgery, Goldstein says, "Every week I kept thinking,
'this is as good as it gets'?" Then, she discovered
by the sixth week, as predicted by her surgeon, that
her eyesight was noticeably better and eventually
stabilized.
"I would tell others to be patient about their
expected outcome," she advises. "Even though
with LASIK you can expect quicker results, I'm happy
with the choice of PRK."
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