ANSWERS
05/20/1996

<TITLE> UPDATE ON EXCIMER LASERS FOR NEARSIGHTEDNESS</TITLE>
<PRE>

T96-36                                     Sharon Snider
May 20, 1996                               (301) 443-3285

          UPDATE ON EXCIMER LASERS FOR NEARSIGHTEDNESS

     FDA has been receiving inquiries and complaints about the
widespread and sometimes misleading promotion of excimer lasers
to treat nearsightedness.  The following can be used to answer
questions.
     FDA has approved two laser systems for use in
photorefractive keratectomy (PRK) since last fall--the SVS Apex
Excimer Laser System made by Summit Technology Inc., Waltham,
Mass., and the VISX Excimer Laser System, models B and C, made by
VISX Inc., Santa Clara, Calif.
     PRK is a procedure in which an excimer laser is used to
vaporize part of the surface layer of the cornea.   Both lasers
were approved to correct mild to moderate nearsightedness.
     In recent months, this procedure has been increasingly
advertised and promoted across the country.
     FDA and the Federal Trade Commission's Bureau of Consumer
Protection recently notified the eye care community that all
advertising and promotion for PRK should be truthful and
substantiated and that consumers should be given sufficient
information about the procedure to make an informed decision.
                             -More-                                    Page 2, T96-36, Update PRK
     In a joint letter May 7, FDA and the FTC said advertising or
promotion should contain enough information about the risks and
limitations of PRK to prevent deception.  They said unrealistic
claims such as "throw away your eye glasses" and unsubstantiated
claims about success rates could be misleading to consumers.
     In fact, in clinical studies about 5 percent of patients
continued to need glasses after PRK all the time for distance,
and up to 15 percent needed glasses occasionally, such as when
driving.  Many patients experienced mild corneal haze following
surgery and some experienced glare and halos around lights. 
These conditions diminished or disappeared in most patients in
six months.  For about 5 percent of patients, best corrected
vision was slightly worse after surgery than before.
     Questions have also been raised about using the excimer
laser to treat both eyes at the same time.  The patient brochures
developed by the manufacturers and reviewed by FDA recommend a
three month wait between each eye surgery to allow vision to
stabilize.
     Questions have also been raised about the use of the excimer
laser for LASIK, surgery for nearsightedness that is done below
the cornea's surface.  Use of the laser for this purpose has not
been evaluated by FDA and is outside the approved use.
     At their discretion, individual doctors may choose to use
the laser to treat both eyes at once, or to perform LASIK 
                             -More-                                  Page 3, T96-36, Update PRK
procedures.  Such uses fall under "practice of medicine," and are
not regulated by FDA.  However, promotion and advertising of
lasers by manufacturers and physicians should be limited to the
uses approved by FDA.
     Excimer lasers have not been shown to be safe and effective
for severe nearsightedness, farsightedness or astigmatism. 
People who currently require glasses to read will continue to
need them after PRK.  As people age, they may need glasses to
read even though they have had PRK.  Also, long term risks of PRK
to the cornea beyond three years have not been studied.
     Prospective PRK patients should know that an individual's
choice of laser surgery to correct nearsightedness should be made
only after careful consideration of alternative means of
correction and the potential risks of this surgery.  This surgery
is performed on healthy eyes and cannot be reversed.
     PRK should not be performed on people with uncontrolled
vascular disease, auto-immune disease or certain eye diseases, or
on pregnant women.  People who previously have had radial
keratotomy (RK) to correct nearsightedness should be strongly
discouraged from having PRK.  In clinical studies, patients who
previously had RK experienced a greater loss of visual acuity
after PRK than those who did not.
     Use of excimer lasers for PRK is restricted to practitioners
trained in laser refractive surgery and in the calibration and
operation of the laser.
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