Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-25 @ 2:40 AM
NCT ID:
NCT05229133
Eligibility Criteria:
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 manifest refraction 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 lens wear: Stable refraction (within ±0.5 D), as determined by MRSE, on two consecutive examinations at least 1 week apart.
13. Patient willing and able to return to the study site for the follow-up visits, in the judgement of the investigator.
Exclusion Criteria:
1. Wearing of contact lenses pre-operatively i) soft contact lenses: \<2 weeks before Visit 1 OR from Visit 1 till the day of surgery ii) hard contact lenses: \<1 month before 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 precludes transmission of laser wavelength or that distorts laser light
3. Residual, recurrent, or active ocular disease or corneal abnormality (including, but not 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 negatively affect 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 either refractive 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 on corneal topography
15. At the time of inclusion, participation in other medical device clinical trials within one month or in drug clinical trials within 3 months
16. Diagnosis of autoimmune disease, connective tissue disease, clinically significant atopic disease, diabetes or AIDS and other acute or chronic illnesses that increases the risk to the subject or confounds the outcomes of this study in the opinion of the study principal investigator
17. Known psychotic disorders associated with delusions (e.g. schizophrenia)
18. Woman who is pregnant or nursing
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05229133
Study Brief:
Protocol Section:
NCT05229133