A PHASED, PROSPECTIVE, MULTI-CENTER STUDY OF THE ELITA SYSTEM

Inclusion Criteria:

To be considered for enrollment, subject must:

1. Age ≥22 years old.

2. Subjects with myopic refractive error up to -10.00 D sphere and astigmatism up to -5.00 D with the sum of sphere and cylinder between -1.00 D and -10.00 D using minuscylinder convention based on manifest refraction.

3. Anticipated residual corneal stromal thickness of at least 250 microns based onpreoperative corneal pachymetry minus calculated maximum lenticule thickness to beextracted.

4. Uncorrected visual acuity of 20/40 or worse.

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

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

7. Less than or equal to 0.75 D difference between cycloplegic and manifest refractionsphere.

8. A stable refractive error (based on a previous exam, medical records, lensometry, orprescription at least 12 months prior to the preoperative manifest refraction), asdefined by a change of ≤0.50 D in MRSE and ≤0.50 D in MRC. Additionally, theastigmatic axis must also be within 15 degrees for eyes with >0.50 D of preoperativeand historical manifest cylinder.

9. Any subject eye with a history of contact lens wear within the last 4 weeks mustdemonstrate refractive stability according to the following:

Rigid, toric, or extended wear contact lenses (toric or spherical) must be removed for at least 2 weeks and soft contact lenses (spherical) for at least 3 days prior to the first refraction used to establish stability.

Two consecutive manifest refractions and keratometry readings must be conducted at least 7 days apart.

Refractive stability is defined as a change of not more than 0.50 D in manifest refractive sphere and cylinder as well as keratometry meridian (either axis) between measurements.

If the subject meets the refractive stability criteria, contact lens wear is not permitted for 2 weeks (rigid/toric/extended wear) or 3 days (soft) prior to surgery 14. Willing and capable of complying with follow-up examinations for the duration of the study.

15. Signed informed consent or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment.

Exclusion Criteria:

Subjects will not be eligible to take part in the study if subjects:

1. Concurrent use of systemic (including inhaled) medications that may impair healing,including but not limited to: antimetabolites, isotretinoin (Accutane®) within 6months of treatment, and amiodarone hydrochloride (Cordarone®) within 12 months oftreatment. NOTE: The use of inhaled or systemic corticosteroids, whether chronic or acute,within the past 6 months is deemed to adversely affect healing and subjects usingsuch medications are specifically excluded from eligibility.

2. History of any of the following medical conditions, or any other condition thatcould affect wound healing: collagen vascular disease, autoimmune disease,immunodeficiency diseases, ocular herpes zoster or herpes simplex, endocrinedisorders (including, but not limited to unstable thyroid disorders and diabetes),lupus, and rheumatoid arthritis. NOTE: The presence of diabetes (either type 1 or 2), regardless of disease duration,severity, or control, will specifically exclude subjects from eligibility.

3. Subjects with a cardiac pacemaker, implanted defibrillator or other implantedelectronic device.

4. History of prior intraocular or corneal surgery (including cataract extractionand/or refractive surgery), existing corneal implant, active ophthalmic disease orabnormality (including, but not limited to, symptomatic blepharitis, recurrentcorneal erosion, history or evidence of corneal ulcer (including but not limited topresence of visible corneal scar, abnormal topography is NOT necessary), clinicallysignificant dry eye disease, neovascularization > 1 mm from limbus, retinaldetachment/repair, clinically significant lens opacity, clinical evidence oftrauma/lesions, corneal opacity within the central 9 mm and visible on topography.

5. Evidence of glaucoma regardless of medication regimen or control, an IOP greaterthan 21 mmHg at screening or propensity for narrow angle glaucoma.

6. Evidence of keratoconus, pellucid marginal degeneration, corneal dystrophy orirregularity, unstable (distorted/not clear) corneal mires on central keratometryimages, corneal edema, corneal lesion, hypotony, or abnormal topography. Cornealthickness thinner than 490 microns at the thinnest point.

7. Known sensitivity or inappropriate responsiveness to any of the medications used inthe postoperative course.

8. Either eye does not meet all inclusion criteria and does not fall within approvedindications for treatment using femtosecond or excimer Laser.

9. Desire for monovision correction

10. Women who are pregnant, breast-feeding, or intend to become pregnant during thestudy. Note: Women who were pregnant or nursing may not be enrolled until 6 months aftereither delivery or have stopped nursing and there is documented refractivestability.

11. Concurrent participation or participation within 60 days prior to preoperative visitin any other clinical trial

12. Subjects with increased risk of experiencing suction loss during treatment (difficulty achieving or maintaining suction) based on surgeon's determination, suchas subjects with: Deep orbits, strong blinks, anxiety, pterygium, difficultyfollowing directions or unable to fixate, head tremor, or any other findingsuggesting increased risk of a decentered or malformed lenticule.