[Shtoom] Check this out LASIK Surgery Checklist, Jerry Katzman MD
paul.kholer at gmail.com
Thu Feb 7 11:08:16 CET 2008
Q: Can you refer me to a good LASIK surgeon in my area?
A: Refer to the Other Resources section of this site. You may want to
contact the organizations listed there for additional information.
While FDA regulates medical devices and drugs, FDA does not regulate
the practice of medicine and does not have a registry of doctors. FDA
does not know of any government agency that can provide a referral for
any medical procedure. You may want to go to your library and see if
there is a local community services magazine that may provide
comparison information of services for doctors in your area.
Q: How do I report a bad experience or who do I notify about a 'bad' doctor?
A: If you had a bad experience or sustained an injury, you should file
a voluntary MedWatch report (1-800-FDA-1088) to the FDA. Also, you
could contact your state medical licensing board and file a complaint
with them. In addition, you could contact your state health department
or consumer complaint organization (e.g., Better Business Bureau).
Q: How much does LASIK cost?
A: The FDA regulates the safety and effectiveness of medical devices
for their intended use. The FDA does not regulate the marketing of or
any fees associated with the use of that product. Again, you may want
to go to your library and see if there is a local community services
magazine that may provide comparison information of services for
doctors in your area.
Q: How can I find out if a particular laser has been approved to treat
my refractive error (nearsightedness, farsightedness and/or
A: You can find approved devices, their approval date, and a synopsis
of the approved indications on the FDA-APPROVED LASERS page.
Q: If the laser I am interested in has not yet been approved for a
particular indication, how can I find out when it will be approved?
A: Confidentiality restrictions prohibit FDA from commenting on the
status of a device under regulatory review, but you can try asking the
laser company for this information.
Jerry Katzman MD
Q: Which laser is the best for treating my refractive error?
A: FDA does not provide comparisons between refractive lasers. FDA
approves the safety and effectiveness of a device independent of any
other product. However, you are encouraged to review the approval
documents to assess the capabilities of specific laser systems and
make your own comparisons. The approval number for each laser on the
FDA-APPROVED LASERS page is linked to these documents, which provide
additional, detailed information about the clinical trial results and
indications for use. Discuss any concerns you may have with your
Q: How does wavefront LASIK compare to conventional LASIK?
A: Wavefront adds an automatic measurement of more subtle distortions
(called higher order aberrations) than just nearsightedness,
farsightedness, and astigmatism corrected by conventional LASIK.
However, these "higher order aberrations" account for only a small
amount (probably no more than 10%) of the total refractive error of
the average person's eye. Conventional LASIK increases higher order
aberrations. Although wavefront-guided treatments attempt to eliminate
higher order aberrations, results from the clinical studies have shown
that the average aberrations still increase, but less than they do
after conventional LASIK. In a few studies comparing wavefront-guided
LASIK to conventional LASIK, a slightly larger percentage of subjects
treated with wavefront LASIK achieved 20/20 vision without glasses or
contact lenses compared to subjects treated with conventional LASIK.
Patient selection ("When is LASIK not for me?") and the experience and
competence of the surgeon are still the most important considerations.
Q: What percentage of patients attain 20/20 vision or better without
glasses or contacts?
A: Data in the Approval Orders and related documents summarizes the
outcomes from the clinical trials submitted to the FDA for each
approved device. Links to these documents are included on the
FDA-APPROVED LASERS page.
Q: Can you send me more information or respond to my concern?
A: No. The most current information we have about LASIK is on this
website and we update it routinely. We do not have the resources to
respond directly to patient concerns or questions. We encourage you to
discuss these matters with your doctor.
Q: Can I use information from the FDA LASIK website?
A: Yes. Information on this website can be used freely by the public.
Any use on other websites or in publications should be properly cited.
Jerry Katzman MD
For more information visit http://dr-jerry-katzman.com
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