Efficacy and Safety of CLEAR in Myopia and Astigmatism in Chinese Population

Inclusion Criteria:

1. Medically suitable for corneal refractive surgery
2. Signed informed consent form
3. Age ≥ 18 years
4. Pre-operative BCVA ≥ 5.0 (corresponding to 20/20 as per Snellen chart lines)
5. Myopia sphere from -0.5 D to -10.00 D
6. Maximum cylinder diopter of -5.00 D
7. Maximum resulting MRSE of -12.5 D
8. Calculated residual stromal thickness ≥ 250 microns
9. Non-contact IOP < 21mmHg
10. Stable refraction for the past year, as demonstrated by a change in manifestrefraction spherical equivalent (MRSE) of ≤ 0.50 D
11. A difference between cycloplegic refraction spherical equivalent and MRSE < 0.75 D.
12. For contact lens wearers (where applicable) after pre-operative stop of contact lenswear: Stable refraction (within ±0.5 D), as determined by MRSE, on two consecutiveexaminations at least 1 week apart.
13. Patient willing and able to return to the study site for the follow-up visits, in thejudgement of the investigator.

Exclusion Criteria:

1. Wearing of contact lenses pre-operatively i) soft contact lenses: <2 weeks beforeVisit 1 OR from Visit 1 till the day of surgery ii) hard contact lenses: <1 monthbefore Visit 1 OR from Visit 1 till the day of surgery iii) therapeutic contact lenses (such as Ortho-K): <3 months before Visit 1 OR from Visit 1 till the day of surgery
2. Corneal disease or pathology, such as corneal scaring or opacity, that precludestransmission of laser wavelength or that distorts laser light
3. Residual, recurrent, or active ocular disease or corneal abnormality (including, butnot limited to ocular herpes zoster or simplex, active infections and inflammation)
4. History of ocular herpes simplex or herpes zoster keratitis
5. 3 months before the inclusion have taken systemic medication likely to negativelyaffect wound healing, such as glucocorticosteroide or antimetabolites
6. Severe dry eye
7. Glaucoma
8. Nystagmus or hemofacial spasm preventing placement of the patient interface
9. Previous corneal surgery of any kind, including any type of surgery for eitherrefractive or therapeutic purposes
10. Unstable central keratometry readings
11. Mesopic pupil diameter > 8.0 mm
12. Keratometry readings via Sim-K values less than 40.00 D
13. Allergy to medications required in surgery, pre- and post-operative treatment
14. Keratoconus or keratectasia, including patients with suspicion of keratoconus oncorneal topography
15. At the time of inclusion, participation in other medical device clinical trials withinone month or in drug clinical trials within 3 months
16. Diagnosis of autoimmune disease, connective tissue disease, clinically significantatopic disease, diabetes or AIDS and other acute or chronic illnesses that increasesthe risk to the subject or confounds the outcomes of this study in the opinion of thestudy principal investigator
17. Known psychotic disorders associated with delusions (e.g. schizophrenia)
18. Woman who is pregnant or nursing