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 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT06774651
Eligibility Criteria:
Inclusion Criteria:
* \>/= 21 years of age and \</= 50 years of age.
* Cycloplegic spherical equivalent of \>-1.00D
* Refractive cylinder -2.00 D or less; anisometropia \<1.00D
* Best spectacle corrected visual acuity (BSCVA) of 6/12 or better in BOTH eyes.
* Spherical or cylindrical error has progressed at -0.50D or less per year from date of baseline measurement.
* Contact lens wearers must have removed contact lenses at least two (2) weeks before the baseline measurement.
* No evidence of irregular astigmatism on corneal topography.
* Available to attend post-operative examinations for a 12-month period.
Exclusion Criteria:
* Progressive or unstable myopia and/or astigmatism.
* Clinical or corneal topographic evidence of keratoconus.
* Patients who want bilateral SMILE procedure
* Patients who want extracted corneal lenticule to be stored for future refractive surgery.
* Residual, recurrent or active ocular disease such as uveitis, severe dry eyes, severe allergic eye disease, glaucoma, visually significant cataract and retinal disease.
* Previous corneal surgery or trauma within the corneal treatment zone.
* Corneal vascularisation within 1mm of the corneal treatment zone.
* Taking systemic medications likely to affect wound healing, such as corticosteroids and antimetabolites.
* Systemically immunocompromised.
* Systemic disease likely to affect wound healing, such as diabetes, connective tissue disease and severe atopy.
* Pregnant or nursing.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
50 Years
Study:
NCT06774651
Study Brief:
Protocol Section:
NCT06774651