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 @ 10:45 PM
Ignite Modification Date:
2025-12-24 @ 10:45 PM
NCT ID:
NCT06717035
Eligibility Criteria:
Inclusion Criteria
Subjects must meet all the criteria listed to participate in the study:
1. All ethnicities
2. Age between 6 and 15 years
3. Refraction -0.50D till - 7.00D and astigmatism ≤ 3.00D
4. Anisometropia ≤ 3.00D
5. Best corrected monocular distance high contrast VA ≤ 0.10 logMAR
6. Normal Binocular vision (fusion and stereopsis)
Exclusion Criteria
All subjects meeting any of the exclusion criteria at baseline will be excluded from participation:
1. Ocular and systemic abnormalities
2. Children who do not cooperate
3. Binocular vision anomalies (strabismus, suppression)
4. Previous use of myopia management treatment (spectacles, atropine, CLs)
5. Neurological disorders
6. Premature infants
7. Children who do not wear their glasses correctly for intermediate and near vision activities
8. Children who do not meet the inclusion criteria
9. No informed consent given by parents of child for participation in the clinical study
10. Subject is allergic to cycloplegic eye drops
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
15 Years
Study:
NCT06717035
Study Brief:
Protocol Section:
NCT06717035