Evaluation of Outcomes Using the Amo Advanced CustomVue Ilasik Procedure

Laser in situ keratomileusis (LASIK) surgery has been performed worldwide since 1990. More
recently, customized corneal ablation utilizing wavefront-sensing technology to determine the
optical aberration of a patient's cornea has optimized LASIK surgery results. Prior to the
introduction of wavefront-guided laser vision correction, the variables used for correcting
refractive errors were limited to sphere and cylinder. With the introduction of wavefront
laser vision correction surgeons are now able to provide individualized laser-induced corneal
tissue resection based not only on sphere and cylinder measurements, but also on an attempt
to treat 3rd through 6th higher-order aberrations (HOAs) utilizing Zernike polynomial
wavefront reconstructions and Fourier transformation.

Advanced Medical Optics, Inc. (AMO) has recently introduced the Advanced CustomVue™ iLASIK
procedure which utilizes the WaveScan WaveFront® System, a STAR S4 IR™ Excimer Laser System
and IntraLase™ FS System technology to provide the broadest range of wavefront-guided FDA
approved usages and an unprecedented level of precision and accuracy for patients undergoing
LASIK surgery. The procedure leverages Iris Registration, Fourier algorithms, VSS™ and VRR™
technologies and 3D ActiveTrak™ to ensure precise corneal ablation.1, 2

Inclusion Criteria:Subjects MUST fulfill the following conditions to qualify for enrollment
into the trial Both eyes must have a manifest refractive error from -0.50 D to -6.00 D, a
cylinder component up to -3.00 D, and a maximum manifest spherical equivalent of -6.00 D.

21 years of age or older at the time of the pre-operative examination. Both eyes must have
a BSCVA of 20/20 or better; Both eyes must have a minimum pupil size of at least 6.0mm in
dim illumination on wavescan.

Both eyes must demonstrate refractive stability confirmed by clinical records or previous
glasses. Refractive stability shall be documented by a change of less than or equal to 0.50
diopter (sphere and cylinder) at an exam at least 12 months prior to the baseline
examination. The astigmatic axis must also be within 15 degrees for eyes with cylinder
greater than 0.50 D.

Willing and able to comply with scheduled visits and other study procedures.

Exclusion Criteria:Subjects with ANY of the following conditions on the eligibility exam
may NOT be enrolled into the trial.

Subjects who use concurrent topical or systemic medications that may impair healing,
including but not limited to: antimetabolites, isotretinoin (Accutane®) within 6 months of
treatment, and amiodarone hydrochloride (Cordarone®) within 12 months of treatment. Also,
the use of topical or systemic corticosteroids, whether chronic or acute Subjects with a
history of any of the following medical conditions, or any other condition that could
affect wound healing: uncontrolled diabetes, collagen vascular disease, autoimmune disease,
immunodeficiency diseases, ocular herpes zoster or simplex, endocrine disorders (including,
but not limited to unstable thyroid disorders and diabetes), lupus, and rheumatoid
arthritis.

Subject must not have a history of prior intraocular or corneal surgery (including cataract
extraction), active ophthalmic disease or abnormality (including, but not limited to,
blepharitis, recurrent corneal erosion, dry eye syndrome, neovascularization > 1mm from
limbus), clinically significant lens opacity, clinical evidence of trauma (including
scarring), or with evidence of glaucoma or propensity for narrow angle glaucoma in either
eye.

The subject must not have any evidence of keratoconus, corneal irregularity, or abnormal
videokeratography in either eye.

Subjects with known sensitivity or inappropriate responsiveness to any of the medications
used in the post-operative course.

Patients who do not achieve Iris registration at the time of their wavescan. Patients
seeking monovision Any clinically significant, serious or severe medical or psychiatric
condition that may increase the risk associated with study participation or may interfere
with the interpretation of study results.

Participation in (or current participation) any investigational drug or device trial within
the previous 30 days prior to the start date of this trial.

The principal investigator reserves the right to declare a patient ineligible or
non-evaluable based on medical evidence that indicates the patient is unsuitable for the
trial.