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 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT06110520
Eligibility Criteria:
Inclusion Criteria:
* Children must be between 5 to \<13 years old.
* Diagnosis of Myopia (ICD-10-CM Diagnosis
Code H52.13) with refractive error:
1. Myopia -1.00D to -6.00D spherical equivalent (SE) in both eyes
2. Astigmatism \<=1.50D in both eyes
3. Anisometropia \<=1.00D SE • Relocation outside of the CCHMC area within the next 12 months is not anticipated.
Exclusion Criteria:
Current or previous myopia treatment with atropine, pirenzepine, or other antimuscarinic agents
* Current or previous use of bifocals, progressive addition lenses, or multi-focal contact lenses
* Current or previous use of orthoK, rigid gas permeable, or other contact lenses being used to reduce myopia progression
* Current or prior history of manifest strabismus, amblyopia, or nystagmus
* Abnormality of cornea, lens, central retina, iris, or ciliary body
* Prior eyelid, strabismus, intraocular, or refractive surgery
* Down syndrome or cerebral palsy
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
12 Years
Study:
NCT06110520
Study Brief:
Protocol Section:
NCT06110520