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VISX CustomVue™ Laser Vision Correction Procedure Approved by
the FDA
It approval
from the U.S. Food and Drug Administration (FDA) for CustomVue™
laser vision correction. This wavefront ablation procedure sets a
new standard for vision correction, with the potential to enable
better vision than with contacts or glasses.
The FDA
approval allows for WaveScan® diagnosis and CustomVue treatment of
patients with nearsightedness and astigmatism. This approval is
specifically for wavefront-guided LASIK for correction of myopic
astigmatism up to -6.00D MRSE, with cylinder between 0.00 and
-3.00D.
The CustomVue procedure tailors a unique correction
for each individual. It employs the VISX WaveScan® System, a new
diagnostic system that captures a "fingerprint" of the eye which is
25 times more precise than what was previously measurable by
standard methods for glasses and contact lenses. WaveScan evaluates
more than nearsightedness, farsightedness, and astigmatism; it
captures other, more specific imperfections in each individual's
vision. This data is then used to generate an individualized
treatment for a CustomVue procedure.
FDA clinical study data
presented at the 2003 ASCRS Symposium showed that at one year
following the procedure, 98% of the clinical study participants
could see 20/20 or better UCVA, while nearly 70% had either the same
or better post-op UCVA compared to their pre-op BSCVA. A six-month
evaluation of the clinical study participants showed that four times
as many participants were very satisfied with their night vision
after the VISX CustomVue procedure, compared to their night vision
before with glasses or contacts.
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