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."
