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Food and Drug Administration
U.S. Department of Health and Human Services
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FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.


T97-17                         Sharon Snider:     301-443-3285
April 25, 1997                 
                               Consumer Hotline:  800-532-4440


   FDA APPROVES EXCIMER LASER FOR MILD TO MODERATE ASTIGMATISM

     The Food and Drug Administration today approved an expanded
use of the Visx Inc. excimer laser to include the treatment of
nearsighted people who also have mild to moderate astigmatism.
     Approval was based on a review of clinical studies on safety
and effectiveness submitted by the Santa Clara, Calif.-based
company and on the recommendation of the Ophthalmic Devices Panel
of FDA's Medical Devices Advisory Committee.
     The laser was previously approved by the FDA for use in
photorefractive keratectomy to treat mild to moderate myopia, or
nearsightedness.  Nearsightedness affects some 63 million
Americans who now wear eye glasses or contact lenses.  Most
people who are nearsighted also have astigmatism.
     Astigmatism is an eyesight disorder that prevents focusing
due to uneven curvature of the outside surface of the cornea of
the eye.  It is currently corrected with eye glasses or contact
lenses.
     The expanded approval is for treating people age 21 and
older who are mildly to moderately nearsighted and who also have 
mild to moderate astigmatism.  The laser is not approved for
treating severe nearsightedness or severe astigmatism.
     FDA's approval was based on clinical studies conducted by
the manufacturer in which 116 eyes were treated with the laser,
and 82 eyes were followed up two years later.  Approval also was
based on supplemental safety and effectiveness information from
international clinical studies involving 625 eyes.
     Side effects experienced by patients two years after
treatment included the following: corneal haze (1.2%); increase
of intraocular pressure (2.4%);  loss of best corrected vision
with eye glasses (4.8%); worsening of double vision (5.9%);
worsening of vision corrected with glasses from 20/20 to 20/25
(6.1%); worsening of sensitivity to bright lights (15.5%); and
increased difficulty with night vision (22.6%).  
     FDA has placed a number of restrictions on the use, labeling
and promotion and advertising of the laser.  These include the
following:
     *  Only medical practitioners experienced in corneal
surgery, trained in laser refractive surgery for nearsightedness
and astigmatism and in the calibration and use of the laser may
use the laser.
     *  Patients considering this surgery must be provided with a
patient information booklet which describes the risks and
benefits of the procedure.  The booklet was developed by Visx and
reviewed by FDA.
     *  Prior to surgery, patients must be informed of the
alternatives for correcting astigmatism, including eye glasses,
contact lenses and other types of surgery.
     *  In its advertising and promotion of the product, Visx is
prohibited from comparing its laser to any other laser or any
other method of correcting nearsightedness or astigmatism.
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