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 minus cylinder convention based on manifest refraction.
• •3. Anticipated residual corneal stromal thickness of at least 250 microns based on preoperative corneal pachymetry minus calculated maximum lenticule thickness to be extracted.
• •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 refraction sphere.
• •8. A stable refractive error (based on a previous exam, medical records, lensometry, or prescription at least 12 months prior to the preoperative manifest refraction), as defined by a change of ≤0.50 D in MRSE and ≤0.50 D in MRC. Additionally, the astigmatic axis must also be within 15 degrees for eyes with \>0.50 D of preoperative and historical manifest cylinder.
• •9. Any subject eye with a history of contact lens wear within the last 4 weeks must demonstrate 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.
• •9. Desire for monovision correction
• •10. Women who are pregnant, breast-feeding, or intend to become pregnant during the study.
• •Note: Women who were pregnant or nursing may not be enrolled until 6 months after either delivery or have stopped nursing and there is documented refractive stability.
• •11. Concurrent participation or participation within 60 days prior to preoperative visit in 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, such as subjects with: Deep orbits, strong blinks, anxiety, pterygium, difficulty following directions or unable to fixate, head tremor, or any other finding suggesting increased risk of a decentered or malformed lenticule.