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. These results are indicative of not
only the CustomVue treatment but also the care of the clinical physicians,
the control of the surgical environment by those physicians, the clinical trials'
treatment parameters and the clinical trials' patient inclusion and exclusion criteria.
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. You can find information about the clinical trials below
and in the CustomVue Patient Information Booklet. 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 CustomVue
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 (LOW TO MODERATE MYOPIC ASTIGMATISM):
The VISX STAR S4 Excimer Laser System and WaveScan WaveFront
System is approved to perform wavefront-guided laser assisted in-situ keratomileusis
(LASIK) treatments for the reduction or elimination of low to moderate 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 preoperative 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.
WAVEFRONT-GUIDED LASIK INDICATIONS AND INTENDED USES (HIGH MYOPIC ASTIGMATISM):
The VISX STAR S4 IR Excimer Laser System with VSS
and WaveScan WaveFront System are approved to perform wavefront-guided
laser assisted in-situ keratomileusis (LASIK) treatments for the reduction
or elimination of high myopic astigmatism from -6.00 D to -11.00 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 1.00 D (in
both cylinder and sphere components) for at least one year prior to the date of
preoperative examination. Note that the complete name for this ophthalmic laser
is "STAR S4 IR Excimer Laser System for wavefront-guided
laser assisted in-situ keratomileusis (LASIK) treatments of myopic astigmatism
from -6.00 to -11.00 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 high myopia with or without astigmatism."
Wavefront-guided LASIK for correction of high myopic astigmatism 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 184 eyes.
Of all eyes treated, 180 were evaluated for effectiveness with 97.8% accountability
at 3 months, 178 eyes with 96.7% accountability at 6 months, 170 eyes with 96.5%
accountability at 9 months, and 107 eyes with 93.9% accountability at 12 months.
The studies found that of the 178 eyes eligible for the uncorrected visual acuity
(UCVA) analysis of effectiveness at 6 months, 98.3% were corrected to 20/40 or better,
97.2% were corrected to 20/32 or better, and 84.3% were corrected to 20/20 or better
without spectacles or contact lenses. The study showed that of 83 spherical and
101 astigmatic eyes, no eyes lost 2 or more lines of best corrected vision that
can be obtained with spectacles (BSCVA) and none of the eyes had BSCVA worse than
20/40.
WAVEFRONT-GUIDED LASIK INDICATIONS AND INTENDED USES (HYPEROPIC ASTIGMATISM):
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 hyperopic
astigmatism up to +3.00 D MRSE, with 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 preoperative 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 hyperopic astigmatism up to +3.00 D MRSE, with cylinder between
0.00 and +2.00 D." An acceptable alternate version of this official name is "wavefront-guided
LASIK for correction of hyperopic astigmatism."
Wavefront-guided LASIK for hyperopic astigmatism 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 was based on a clinical trial of 144 eyes (74 primary and 70
secondary). Of all eyes treated, 134 were evaluated for effectiveness with 98.5%
accountability at 3 months, 131 eyes with 97.0% accountability at 6 months, 118
eyes with 90.8% accountability at 9 months, and 27 eyes with 87.1% accountability
at 12 months. The studies found that of the 131 eyes eligible for the uncorrected
visual acuity (UCVA) analysis of effectiveness at 6 months, 97.3% were corrected
to 20/40 or better, and 66.2% were corrected to 20/20 or better in 74 spherical
hyperopia eyes; and 93.0% were corrected to 20/40 or better, and 56.1% were corrected
to 20/20 or better in 57 astigmatic hyperopia eyes.
The study showed that at the 6 month stability time point: there was no 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 that can be obtained with spectacles in either 63 astigmatic hyperopia eyes
or 74 spherical hyperopia eyes; none of the 63 astigmatic hyperopia or 74 spherical
hyperopia eyes had best spectacle corrected visual acuity (BSCVA) worse than 20/25.
During the course of the study, one in 63 eyes with astigmatic hyperopia lost >2
lines of BSCVA at 1 month, no eyes with spherical hyperopia lost >2 lines of BSCVA,
and no eye had a BSCVA worse than 20/40.
WAVEFRONT-GUIDED INDICATIONS AND INTENDED USES (MIXED ASTIGMATISM):
The VISX STAR S4 IR Excimer Laser System with VSS and
WaveScan WaveFront System are approved to perform wavefront-guided
laser assisted in-situ keratomileusis (LASIK) treatments for the reduction
or elimination of naturally occurring mixed astigmatism when the magnitude of 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 preoperative examination.
Note that the complete name for this ophthalmic laser is "STAR S4 IR
Excimer Laser System" for wavefront-guided laser assisted in-situ keratomileusis
(LASIK) treatments of naturally occurring mixed astigmatism when the magnitude of
cylinder (from 1.0 to 5.0 D) is greater than the magnitude of sphere and the cylinder
and sphere have opposite signs. An acceptable alternate version of this official
name is "wavefront-guided LASIK for correction of mixed astigmatism."
Wavefront-guided LASIK for mixed astigmatism 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 86 eyes. Of all eyes treated, 86 were evaluated
for effectiveness with 100.0% accountability at 3 months, 80 eyes with 95.2% accountability
at 6 months, 69 eyes with 86.3% accountability at 9 months, and 63 eyes with 94.0%
accountability at 12 months. The studies found that of the 86 eyes eligible for
the uncorrected visual acuity (UCVA) analysis of effectiveness at 3 months, 95.3%
were corrected to 20/40 or better, 91.9% were corrected to 20/32 or better, and
61.6% were corrected to 20/20 or better without spectacles or contact lenses.
The study showed that of 86 astigmatic eyes, one eye temporarily lost 2 lines of
best corrected vision that can be obtained with spectacles at 1 month and at 6 months,
and none of the eyes had best spectacle corrected visual acuity (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. 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).
PRECAUTIONS:
Long-term risks of wavefront-guided LASIK beyond 12 months have not been studied.
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 for myopic treatments,
and an ablation zone of 9 mm for hyperopic and mixed astigmatism treatments. The
safety and effectiveness of STAR S4 Excimer Laser System have NOT
been established for wavefront-guided surgery in patients with low to moderate myopic
astigmatism: whose WaveScan wavefront diameter 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. The safety
and effectiveness of STAR S4 Excimer Laser System have NOT been established
for wavefront-guided surgery in patients with high myopic astigmatism: whose WaveScan
wavefront diameter is less than 5 mm; for treatments greater than -11 diopters of
MRSE or with greater than 3 diopters of astigmatism. The safety and effectiveness
of STAR S4 Excimer Laser System have NOT been established for wavefront-guided surgery
in patients with hyperopic astigmatism: whose WaveScan wavefront diameter
is less than 5 mm; for treatments greater than +3 diopters of MRSE or with greater
than 2 diopters of astigmatism and for retreatment with CustomVue
LASIK. The safety and effectiveness of the STAR S4 IR Excimer Laser
System have NOT been established for wavefront-guided surgery in patients with mixed
astigmatism: whose WaveScan wavefront diameter is less than 5.00 mm;
for treatments greater than 5.00 D or less than 1.00 D 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 studies for low to moderate myopic astigmatism, hyperopic
astigmatism and mixed astigmatism, the average higher order aberration did not decrease
after CustomVue treatment. In the clinical studies for high myopic
astigmatism, the average higher order aberration increased 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 (LOW TO MODERATE MYOPIC ASTIGMATISM):
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%).
ADVERSE EVENTS AND COMPLICATIONS (HIGH MYOPIC ASTIGMATISM):
The clinical trial showed that the following adverse events or complications occurred
in at least 1% of the 184 eyes at one or more postoperative examinations up to 6
months post-treatment: cells growing under the flap (1.1%); scratch on the surface
of the eye at 1 month or later (2.2%); swelling of the corneal between 1 week and
1 month postoperatively (2.7%) and double vision (or "ghost images") in the operative
eye (6.0%).
The following subjective symptoms were reported as present "often or always" by
a higher percentage of subjects 6 months after treatment than before treatment:
dryness (10.8% vs. 9.3%); halos (21.6% vs. 15.4%); and ghosting or shadowing of
images (2.8% vs. 1.1%).
ADVERSE EVENTS AND COMPLICATIONS (HYPEROPIC ASTIGMATISM):
The clinical trial showed that the following adverse events or complications occurred
in at least 1% of the 144 eyes at any interval up to 6 months post-treatment: cells
growing under the flap (2.1%); feeling of something in the eye (1.4%); double or
ghost images (11.3%); and scratch on the surface of the eye (2.1%).
The following subjective symptoms rated "often or always" were increased in frequency
in the effectiveness cohort at 6 months post-treatment on 131 eyes compared with
pretreatment on 136 eyes: dryness (17% vs. 6%); blurry vision (10% vs. 7%); fluctuation
of vision (14% vs. 6%); halos (10% vs. 5%); double or ghost images (7% vs.3%).
ADVERSE EVENTS AND COMPLICATIONS (MIXED ASTIGMATISM):
The clinical trials showed that the following adverse events or complications occurred
in at least 1% of the 86 eyes at one or more postoperative examinations up to 3
months post-treatment: miscreated flap (1.2%); cells growing under the flap (4.7%);
and double vision (or "ghost images") in the operative eye (8.1%).
The following subjective symptoms were reported as present "often or always" by
a higher percentage of subjects 3 months after treatment than before treatment:
dryness (22% vs. 6%); halos (20% vs. 13%).