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 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT05689567
Eligibility Criteria:
Inclusion Criteria:
1. Age: ≥6 and ≤8 years at enrollment.
2. At least one parent' s Spherical equivalent refraction≤-3.00D.
3. Spherical equivalent refractions (SERs) under cycloplegia: +0.50 to +1.50 diopters (D)
4. Astigmatism ≤1.00 D .
5. Anisometropia ≤1.00 D.
6. Best Corrected Visual Acuity (BCVA) : 1.0 or better
7. Provision of consent written by subject's legal guardian
8. Willing and able to participate in all required activities of the study
Exclusion Criteria:
1. Any of the following abnormalities on the ocular surface, such as trachoma, pemphigoid, chemical injury, heat burn, radiation injury, etc.
2. Eyelid abnormalities (e.g. entropion, ectropion, tumor, edema, blepharospasm, incomplete eyelid closure, severe trichiasis, severe ptosis) ,which affect eyelid function in either eye
3. Eye diseases such as strabismus, amblyopia, anisometropia, fundus diseases, and accommodation abnormality，etc.
4. Prior treatment of myopia control in either eye, including but not limited to drugs, orthokeratology, low-level red-light therapy, etc.
5. Noncompliance with measurement at enrollment.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
8 Years
Study:
NCT05689567
Study Brief:
Protocol Section:
NCT05689567