LASIK Surgery With a New Laser for the Treatment of Myopia Without Astigmatism

Inclusion Criteria:

• Inclusion criteria number 3 to 6, 10, 11 and 12 only apply to eyes planned forinvestigational treatment. Inclusion criterion number 9 applies to both eyes whetherplanned for investigational treatment or not and inclusion criterion number 8 appliesto each eye as specified in the criteria.

1. Informed Consent as documented by signature
2. Medically suitable for corneal refractive surgery
3. Stable refraction over a minimum of 12 months prior to surgery Stable refractionis defined as MRSE change per year in the eye to be treated ≤ 0.50 D and shouldbe confirmed by at least one measurement between 1 and 10 years previous to thestudy.
4. Myopia sphere from -0.5 D to -4.0 D
5. Phases I & II: Maximum cylinder diopter -1.5 D
6. Phase II & III: Maximum cylinder diopter -1.0 D
7. Accurate baseline biometric measurements Accurate baseline biometric measurementsare defined as

• Assessed Manifest Refraction within ± 0.5 D of Objective Refraction
• Less than 0.75 D spherical equivalent (SE) difference between cycloplegicand manifest refractions
• Objective refraction should be assessed by
• Autorefractometer And either/or
• Hartmann-Shack Aberrometer
• Ray tracing Aberrometer

8. Age ≥ 18 years
9. Calculated residual stroma thickness ≥ 300 microns
10. IOP, as measured by non-contact tonometry < 21mmHg
11. Phase I: One of the following

• Amblyopic eye An amblyopic eye is defined as an eye that has decreasedfunctional visual acuity due to an insufficient development in the visualsystem according to the judgement of the investigator, and the followingcriteria
• Pre-operative CDVA up to 20/32 ( 0.63 in decimal convention)
• Pre operative CDVA in the fellow, dominant eye ≥ 20/40 (0.5 in decimalconvention)
• Post-cataract patient, and the following criteria
• Pre-operative CDVA in each eye ≥ 20/40 (0.5 in decimal convention)

12. Phase II & III: Pre-operative CDVA in each eye ≥ 20/40 (0.5 in decimalconvention)
13. Patient willing and able to return to the study site for the follow-up visits, inthe judgement of the investigator

Exclusion Criteria:

• The following exclusion criteria apply for both eyes, whether planned for treatment ornot.

1. Severe local infective or allergic conditions (e.g. blepharitis, past herpessimplex or zoster, allergic eye disease severe enough to require regulartreatment).
2. Corneal disease or pathology, such as but not limited to corneal scarring oropacity, history of viral keratitis, dry eye, recurrent epithelial erosion andFuchs' endothelial dystrophy
3. Manifest or subclinical keratoconus or keratectasia, as diagnosed by cornealtopography and/or anterior optical coherence tomography
4. Patients with degeneration of structures of the cornea, diagnosed keratoconus orany clinical pictures suggestive to keratoconus (form-fruste keratoconus)
5. Corneal thickness < 480 microns
6. Previous corneal surgery of any kind, including surgery for either refractive ortherapeutic purposes in either eye that, in the judgement of the investigatorconfounds the outcome of the study or increases risk for the patient
7. Glaucoma and/or ocular hypertension, whether untreated and under medical control
8. Nystagmus or hemifacial spasm
9. Known allergy to medications used in surgery, pre- and post-operative treatmentat the investigational site
10. Immunocompromised or diagnosis of ophthalmic disease (any of the following):

• ocular herpes zoster or simplex
• lupus
• collagenases
• other acute or chronic illnesses that increases the risk to the participantor confounds the outcomes of this study in the opinion of the investigator

11. Patients with a diagnosed collagen vascular, atopic syndrome, autoimmune orimmunodeficiency disease
12. Known psychotic disorders associated with delusions (e.g. schizophrenia)
13. Drug or alcohol abuse
14. Neurological diagnosis with a GCS > 13
15. Women who are pregnant or nursing or who plan to become pregnant over the courseof this investigation.
16. Inability to follow the procedures of the study in the opinion of theinvestigator, e.g. due to language problems, psychological disorders, dementia,etc.
17. Participation in another interventional study within the 30 days preceding andduring the present study
18. Patients with uncontrolled diabetes
19. Patients who are taking one or both of the following medications:

• Isotretinoin (e.g. Accutane®)
• Amiodarone hydrochloride (e.g. Cordarone®)