Prospective S&E Study of Wavefront-guided PRK for Myopia With iDesign Advanced Wavescan Studio™ System and Star S4 IR™

NOTE: Enrollment open only to military personnel

Inclusion Criteria:

- Signed informed consent and HIPAA authorization.

- Refractive error, based on the iDesign displayed refraction must be myopia with or
without astigmatism with sphere up to -8.00 D, and cylinder between 0.00 D and -4.00 D
with maximum SE of -10.00 D.

- Anticipated residual stromal bed thickness of at least 250 microns as calculated by
the iDesign system.

- Distance Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better

- BSCVA ≥2 lines (≥10 letters) better than distance Uncorrected Visual Acuity (UCVA).

- Less than or equal to 0.75 D difference between cycloplegic and manifest refraction
sphere.

- Stable refractive error as defined by a change of ≤1.00 D in MRSE over at least a 12
month time period.

- Any subject eye with a history of contact lens wear within the last 4 weeks must
demonstrate refractive stability

- Agreement between manifest refraction (adjusted for optical infinity) and iDesign
System refraction chosen for treatment.

- Willing and capable of complying with follow-up examinations for the duration of the
study.

Exclusion Criteria:

- Women who are pregnant, breast-feeding, or intend to become pregnant, or not using an
adequate method of birth control.

- Concurrent use of systemic (including inhaled) medications that may impair healing.

- History of any of the following medical conditions, or any other condition that could
affect wound healing: collagen vascular disease, autoimmune disease, immunodeficiency
diseases, ocular herpes zoster or herpes simplex, endocrine disorders (including, but
not limited to unstable thyroid disorders and diabetes), lupus, and rheumatoid
arthritis.

- Subjects with a cardiac pacemaker, implanted defibrillator or other implanted
electronic device.

- History of prior intraocular or corneal surgery, active ophthalmic disease or
abnormality, retinal detachment/repair, clinically significant lens opacity, clinical
evidence of trauma, corneal opacity within the central 9 mm and visible on topography,
at risk for developing strabismus, or with evidence of glaucoma or propensity for
narrow angle glaucoma.

- Evidence of keratoconus, corneal dystrophy or irregularity, or abnormal topography

- Known sensitivity or inappropriate responsiveness to any of the medications used in
this study.

- If either eye does not meet all inclusion criteria

- Desire to have monovision.

- Participation in any other clinical study, with the exception of the fellow eye in
this study.