PRK Status in U.S. 
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 PRK Status in U.S.

INVESTIGATIONAL STATUS OF THE EXCIMER LASER

In the United States, the F.D.A. (Food and Drug Administration)
is studying the excimer laser procedure in a three phased trial
to examine its safety and effectiveness. Preliminary results
equaled or exceeded the results of previous Radial Keratotomy
(RK) trials in both safety and effectiveness. The F.D.A.,
however, requires a minimum follow-up period, making late 1995
the earliest approval date in the U.S.. The procedure is no
longer considered investigational in many countries around the
world. In Europe and Asia, tens of thousands of procedures have
been successfully performed with exceptional safety. There have
been no unexpected long-term problems experienced by patients
who underwent the procedure in the late 1980's. Germany,
Sweden, Italy, and England have been leaders in the excimer
laser procedure.

In Canada, the procedure is also being studied as part of a
clinical trial. More than 30,000 procedures have been performed
in Canada. Only a limited number of trained doctors in selected
centers can offer the procedure.




Mon, 23 Mar 1998 03:00:00 GMT
 
 [ 1 post ] 

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