Measuring Outcomes of LASIK and EVO-ICL in Matched Populations

Inclusion Criteria:

• Preoperatively the Investigator will evaluate each study subject and refer to thedirections for use for EVO+ ICL and Wavefront-Optimized LASIK to confirm thesubject's suitability to proceed with bilateral EVO+ ICL Implantation or bilateralWavefront-optimized LASIK in accordance with the Investigator's standard of care foreach procedure. To ensure similar characteristics across study subjects, theInvestigator will also adhere to the following criteria for each group:

1. Subjects ages 21 to 45 years old.

2. Stable refractive error for at least one year (≤ 0.50 D change in refraction)or stability as determined by the Investigator.

3. Myopia or myopia with astigmatism with spherical equivalent ranging from -3.00D to ≤ -8.00 D (in the spectacle plane) and cylinder in the range of 0.00 D to 4.00 D (in the spectacle plane).

4. Corrected distance visual acuity (CDVA) of 20/20 or better in each eye.

5. Difference between cycloplegic refraction spherical equivalent (CRSE) andmanifest refraction spherical equivalent (MRSE) of ≤0.75 D.

6. Subjects must be able and willing to return for scheduled follow-upexaminations after surgery.

7. Subjects must be able to read, understand and provide written informed consenton the Institutional Review Board (IRB) approved Informed Consent Form (ICF)and provide authorization as appropriate for local privacy regulations.

Exclusion Criteria:

1. Pregnant or nursing women, or those who plan to become pregnant over the courseof this clinical study or has another condition with associated fluctuation ofhormones that could lead to refractive changes.

2. Dry eye syndrome that is unable to be controlled with ocular lubricant(s) ormedication(s) and which may confound study outcomes in the opinion of theInvestigator.

3. Serious acute, chronic, or systemic, non-ophthalmic disease or illness thatwould increase the operative risk, confound the outcome(s) of the study orwhich may preclude study completion (e.g., immunocompromised, connective tissuedisease, clinically significant atopic disease, uncontrolled diabetes, etc.),in the opinion of the Investigator.

4. Ocular condition (other than high myopia) that may predispose the subject tofuture complications, in the opinion of the Investigator. For example:

• Pigment dispersion,

• History or clinical signs of iritis/uveitis,

• History of previous ocular surgery,

• Monocular subjects,

• History or evidence of active or inactive corneal disease (e.g., herpes simplexkeratitis, herpes zoster keratitis, recurrent corneal erosion syndrome, cornealdystrophy, etc.),

• Evidence of retinal vascular disease,

• Keratoconus or keratoconus suspect,

• Glaucoma or glaucoma suspect by exam findings,

• Ocular surface disease other than controlled dry eye syndrome. 5. Subjects whodo not qualify for both study arms:

• Bilateral Wavefront Optimized LASIK

• Bilateral EVO+ ICL implantation

6. Subjects who, in the judgment of the Investigator, present any emotional,physiologic, or anatomical condition which may preclude participation inthis study or provide an inappropriate landscape for the intended studytreatment.
7. Participation in another clinical trial involving ocular procedures withinthe last 6-months.
8. Other conditions or assessment that causes the subject to not be anacceptable candidate for treatment or study participation as clinicallyassessed and documented by the Investigator.