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VISX™ Wavefront-Guided LASIK for
Correction of Myopic Astigmatism, Hyperopic
Astigmatism and Mixed Astigmatism (CustomVue™
LASIK Laser Treatment) Statements
regarding the potential benefits of
wavefront-guided LASIK (CustomVue) are based upon
the results of clinical trials.
Although many clinical trial patients after the CustomVue procedure saw 20/20 or better and/or had or reported having better vision during the day and at night, compared to their vision with glasses or contact lenses before the procedure, your results may vary.
WAVEFRONT-GUIDED LASIK INDICATIONS AND INTENDED USES (LOW TO MODERATE MYOPIC ASTIGMATISM): The VISX STAR S4™ Excimer Laser System and WaveScan WaveFront™ System is approved to perform wavefront-guided LASIK treatments for the reduction or elimination of low to moderate myopic astigmatism up to -6.00 D MRSE, with astigmatism correction 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.
WAVEFRONT-GUIDED LASIK INDICATIONS AND INTENDED USES (HIGH MYOPIC or NEARSIGHTEDNESS ASTIGMATISM): The VISX STAR S4 IRTM Excimer Laser System with VSS™ and WaveScan WaveFront System are approved to perform wavefront-guided LASIK treatments for the reduction or elimination of high myopic astigmatism from -6.00 D to -11.00 D MRSE, with astimatism correction or 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 1.00 D (in both cylinder and sphere components) for at least one year prior to the date of pre-operative examination.
WAVEFRONT-GUIDED LASIK GUIDELINES (HYPEROPIC or FARSIGHTED ASTIGMATISM): The VISX STAR S4 Excimer Laser System and WaveScan WaveFront System are approved to perform wavefront-guided LASIK treatments for the reduction or elimination of hyperopic astigmatism up to +3.00 D MRSE, with astigmatism correction or cylinder between 0.00 and +2.00 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 1.0 D (in both cylinder and sphere components) for at least one year prior to the date of pre-operative examination.
WAVEFRONT-GUIDED GUIDELINES (MIXED ASTIGMATISM): The VISX STAR S4 IR Excimer Laser System with VSS and WaveScan WaveFront System are approved to perform wavefront-guided LASIK treatments for the reduction or elimination of naturally occurring mixed astigmatism when the magnitude of astigmatism correction or cylinder (from 1.0 to 5.0 D) is greater than the magnitude of sphere and the cylinder and sphere have opposite signs; and in patients 21 years of age or older 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.
ALL Wavefront-guided LASIK procedures are elective procedures with the alternatives including but not limited to eyeglasses, contact lenses, photorefractive keratectomy (PRK), conventional LASIK, and other refractive surgeries.
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. For the treatment of low to moderate myopic astigmatism, lower uncorrected visual acuity may be anticipated in the treatment of higher degrees of myopia with and without astigmatism (>-5.0 D MRSE).
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Although many clinical trial patients after the CustomVue procedure saw 20/20 or better and/or had or reported having better vision during the day and at night, compared to their vision with glasses or contact lenses before the procedure, your results may vary.
WAVEFRONT-GUIDED LASIK INDICATIONS AND INTENDED USES (LOW TO MODERATE MYOPIC ASTIGMATISM): The VISX STAR S4™ Excimer Laser System and WaveScan WaveFront™ System is approved to perform wavefront-guided LASIK treatments for the reduction or elimination of low to moderate myopic astigmatism up to -6.00 D MRSE, with astigmatism correction 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.
WAVEFRONT-GUIDED LASIK INDICATIONS AND INTENDED USES (HIGH MYOPIC or NEARSIGHTEDNESS ASTIGMATISM): The VISX STAR S4 IRTM Excimer Laser System with VSS™ and WaveScan WaveFront System are approved to perform wavefront-guided LASIK treatments for the reduction or elimination of high myopic astigmatism from -6.00 D to -11.00 D MRSE, with astimatism correction or 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 1.00 D (in both cylinder and sphere components) for at least one year prior to the date of pre-operative examination.
WAVEFRONT-GUIDED LASIK GUIDELINES (HYPEROPIC or FARSIGHTED ASTIGMATISM): The VISX STAR S4 Excimer Laser System and WaveScan WaveFront System are approved to perform wavefront-guided LASIK treatments for the reduction or elimination of hyperopic astigmatism up to +3.00 D MRSE, with astigmatism correction or cylinder between 0.00 and +2.00 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 1.0 D (in both cylinder and sphere components) for at least one year prior to the date of pre-operative examination.
WAVEFRONT-GUIDED GUIDELINES (MIXED ASTIGMATISM): The VISX STAR S4 IR Excimer Laser System with VSS and WaveScan WaveFront System are approved to perform wavefront-guided LASIK treatments for the reduction or elimination of naturally occurring mixed astigmatism when the magnitude of astigmatism correction or cylinder (from 1.0 to 5.0 D) is greater than the magnitude of sphere and the cylinder and sphere have opposite signs; and in patients 21 years of age or older 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.
ALL Wavefront-guided LASIK procedures are elective procedures with the alternatives including but not limited to eyeglasses, contact lenses, photorefractive keratectomy (PRK), conventional LASIK, and other refractive surgeries.
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. For the treatment of low to moderate myopic astigmatism, lower uncorrected visual acuity may be anticipated in the treatment of higher degrees of myopia with and without astigmatism (>-5.0 D MRSE).
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