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 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT05740293
Eligibility Criteria:
Inclusion Criteria:
* Eligible for the approved VisuMax SMILE procedure according to the Professional Use Information, i.e.
* Spherical refractive error (in minus cylinder format) from -1.00 D through -10.00 D;
* Refraction spherical equivalent not greater in magnitude than 10.00 D;
* Minimum age of 22 years;
* Documentation of stable manifest refraction over the past year as demonstrated by a change in sphere and cylinder of ≤ 0.50 D in magnitude.
* Good candidate for SMILE based on the surgeon's assessment of medical and ophthalmic health, cognitive function, and physical and social limitations
* Intended bilateral SMILE treatment for the correction of myopia with astigmatism (-0.75 to -3.00 D)
* Both eyes targeted for the full distance manifest spherocylindrical refraction
* Fluent English in speaking and reading
* Willingness and ability to return for 6-month postoperative examination
* Signed informed consent
Exclusion Criteria:
* Presence of any of the contraindications of the approved SMILE procedure for the reduction or elimination of myopia with astigmatism, i.e.
* a residual stromal bed thickness that is less than 250 microns from the corneal endothelium;
* abnormal corneal topographic findings, e.g. keratoconus, pellucid marginal degeneration;
* ophthalmoscopic signs of progressive or unstable myopia or keratoconus (or keratoconus suspect);
* irregular or unstable (distorted/not clear) corneal mires on central keratometry images;
* severe dry eye;
* active eye infection or inflammation;
* recent herpes eye infection or problems resulting from past infection;
* active autoimmune disease or connective tissue disease;
* uncontrolled diabetes;
* uncontrolled glaucoma.
* Previous treatment with any form of refractive surgery
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT05740293
Study Brief:
Protocol Section:
NCT05740293