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:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT07126756
Eligibility Criteria:
Inclusion Criteria:
1. Nearsightedness (myopia) between -2.00 diopters and -8.00 diopters
2. Have similar levels of nearsightedness in each eye (2D or less difference between eyes)
3. Less than or equal to 3.00 diopters of astigmatism
4. Total spherical equivalent (SE) of no more than -8.0 D
5. Tricare Prime/Select Beneficiary (military health insurance)
6. Residing within 60 miles radius from Lackland AFB
Exclusion Criteria:
1. Subjects with corneal abnormal findings including signs of keratoconus, keratoconus suspect, abnormal corneal topography, epithelial basement membrane disease, pellucid marginal degeneration, corneal degenerations, progressive and unstable myopia, irregular or unstable corneal mires on central keratometry images, and volunteers whose corneal thickness would cause anticipated treatment would violate the posterior 250 microns (um) of corneal stroma from the corneal endothelium.
2. Subjects with active collagen vascular, connective tissue, autoimmune or immunodeficiency diseases
3. Pregnant or nursing females (pregnancy test will be performed on females subjects of childbearing potential)
4. Systemic disease likely to affect wound healing, such as uncontrolled diabetes and severe atopy
5. Any ocular disease such as advanced/uncontrolled glaucoma, severe dry eye, active eye infection or inflammation, recent herpes eye infection or problems resulting from past infection.
6. 0.25 or 0.50 of manifest astigmatism in the eye randomized to SMILE
7. Taking the medication Isotretinoin (Accutane) or antimetabolites for any medical condition.
8. Potential candidate who cannot provide Informed Consent will not be allowed to participate.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
50 Years
Study:
NCT07126756
Study Brief:
Protocol Section:
NCT07126756