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 @ 4:14 PM
Ignite Modification Date:
2025-12-24 @ 4:14 PM
NCT ID:
NCT06034366
Eligibility Criteria:
Inclusion Criteria:
* Age 6 to 12 years
* Subjects and their guardians agreed to participate in this study
* Best-corrected visual acuity (BCVA) 0.1 (log minimum angle of resolution, LogMAR) or better.
* Initial NITM (spherical equivalent) ≤ -0.25 D
* Cycloplegic refractions ≥ -1.0 D and astigmatism ≤ 2.5 D in both eyes.
* Anisometropia in both eyes ≤ 1.5 D
Exclusion Criteria:
* Children with existing systemic diseases including asthma, collagen disease, immune system disorders, prostate hypertrophy, spastic paralysis, Down's syndrome, severe cardiac, pulmonary, hepatic, and renal dysfunction.
* Patients with glaucoma or high intraocular pressure, ocular inflammatory diseases, strabismus, amblyopia, corneal diseases, diseases of lens, retinal and optic neuropathy
* Regular use of medications that may affect the efficacy of 0.01% atropine, including hairy fruit rutabaga eye drops, tropicamide eye drops, anticholinergic drugs such as pirenzepine and tropicamide, and cholinergic drugs such as carbachol and hairy fruit rutabaga.
* Previous experiences with myopia control therapy.
* A history of allergies to atropine.
* Patients were deemed inappropriate for trial participation by the lead investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
12 Years
Study:
NCT06034366
Study Brief:
Protocol Section:
NCT06034366