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VISX® Wavefront-Guided LASIK for
Correction of Myopic Astigmatism (CustomVue™ LASIK Laser Treatment) Only an eye care professional trained in
laser vision correction can determine whether you are a suitable candidate for
the CustomVue procedure. As with any surgical procedure, there are risks
associated with the CustomVue treatment. Before deciding whether to have the
CustomVue procedure, you should ask your doctor for and carefully review the
Patient Information Booklet. It is important to discuss the risks associated
with the procedure and any questions you may have about the procedure with your
doctor. WAVEFRONT-GUIDED LASIK INDICATIONS
AND INTENDED USES: The VISX STAR S4™ Excimer Laser System
and WaveScan WaveFront® System are approved to perform wavefront-guided laser
assisted in-situ keratomileusis (LASIK) treatments for the reduction or
elimination of myopic astigmatism up to -6.00 D MRSE, with cylinder between 0.00
and -3.00 D in patients 21 years of age or older; and in patients with
documented evidence of a change in manifest refraction of no more than 0.50 D
(in both cylinder and sphere components) for at least one year prior to the date
of pre-operative examination. Note that the complete name for this ophthalmic
laser is “STAR S4™ ActiveTrak® Excimer Laser System for wavefront-guided
laser assisted in-situ keratomileusis (LASIK) treatments of myopic astigmatism
up to -6.00 D MRSE, with cylinder between 0.00 and -3.00 D.” An acceptable
alternate version of this official name is “wavefront-guided LASIK for
correction of myopic astigmatism.” Wavefront-guided LASIK is an elective
procedure with the alternatives including but not limited to eyeglasses, contact
lenses, photorefractive keratectomy (PRK), conventional LASIK, and other
refractive surgeries. Approval of the application is based on a clinical trial
of 351 eyes (189 primary and 162 secondary). Of all eyes treated, 318 were
evaluated for effectiveness with 98.8% accountability at 3 months, 277 eyes with
96.9% accountability at 6 months, 102 eyes with 95.3% accountability at 9
months, and 86 eyes with 95.6% accountability at 12 months. The studies found
that of the 277 eyes eligible for the uncorrected visual acuity (UCVA) analysis
of effectiveness at 6 months, 100% were corrected to 20/40 or better, and 95.8%
were corrected to 20/20 or better in 71 spherical myopia eyes; and 99.5% were
corrected to 20/40 or better, and 93.2% were corrected to 20/20 or better in 206
astigmatic myopia eyes. The study showed that at the 3 month
stability time point: there was a loss of ≥ 2 lines of best corrected
vision that can be obtained with spectacles in 1 of 239 astigmatic myopia eyes
and there was no loss of ≥ 2 lines of best corrected vision in 79
spherical myopia eyes; there was 1 of 239 astigmatic myopia eyes with best
spectacle corrected visual acuity (BSCVA) worse than 20/25 and none in 79
spherical myopia eyes with BSCVA worse than 20/25. During the course of study,
no eye lost >2 lines of BSCVA and no eye had a BSCVA worse than 20/40. CONTRAINDICATIONS: Wavefront-guided LASIK is
contraindicated in patients with collagen vascular, autoimmune or
immunodeficiency disease, signs of keratoconus or abnormal corneal topography,
patients taking isotretinoin (Accutane®*) or amiodarone hydrochloride (Cordarone®†)
or are pregnant or nursing. WARNINGS: Wavefront-guided LASIK is not recommended in patients who have diabetes, a history of Herpes simplex or Herpes zoster keratitis, significant dry eye that is unresponsive to treatment, or severe allergies. Lower uncorrected visual acuity may be anticipated in the treatment of higher degrees of myopia with and without astigmatism (>-5.0 D MRSE). PRECAUTIONS: The safety and effectiveness of
wavefront-guided LASIK surgery has ONLY been established with an optical zone of
6 mm and an ablation zone of 8 mm. Long term risks of wavefront-guided LASIK for
myopic astigmatism beyond 12 months have not been studied. The safety and
effectiveness of STAR S4 Excimer Laser System have NOT been established for
wavefront-guided surgery in patients: whose WaveScan®-measured pupil size is
less than 6 mm; for treatments greater than -6 diopters of MRSE or with greater
than 3 diopters of astigmatism and for retreatment with CustomVue LASIK. Although the WaveScan WaveFront System
measures the refractive error and wavefront aberrations of the human eyes,
including myopia, hyperopia, astigmatism, coma, spherical aberration, trefoil,
and other higher order aberrations through sixth order, in the clinical study
for this PMA, the average higher order aberration did not decrease after
CustomVue treatment. It is possible, after wavefront-guided
LASIK treatment, that patients will find it more difficult than usual to see in
conditions such as very dim light, rain, snow, fog, or glare from bright lights
at night. Visual performance possibly could be worsened by large pupil sizes or
decentered pupils. Pupil size should be evaluated under mesopic illumination
conditions. ADVERSE EVENTS AND COMPLICATIONS: The clinical trial showed that the following adverse events or complications occurred in at least 1% of the 351 eyes at any interval up to 6 months post-treatment: inflammation of the cornea under the flap (1.4%); double or ghost images (1.4%); and scratch on the surface of the eye (1.4%). The following subjective symptoms
frequency rated “often or always” were increased in the effectiveness cohort
at 6 months post-treatment on 258 eyes compared with pre-treatment on 332 eyes:
dryness (9% vs. 6%); fluctuation of vision (3% vs. 2%); glare (4% vs. 2%) and
halos (7% vs. 5%). * Accutane® is a registered trademark
of Hoffmann-La Roche Inc. † Cordarone® is a registered
trademark of Sanofi-Synthelabo, Inc. © May 2003 VISX, Incorporated  
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