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 @ 3:56 PM
Ignite Modification Date:
2025-12-24 @ 3:56 PM
NCT ID:
NCT05888792
Eligibility Criteria:
Inclusion Criteria:
* SER: -0.75D or below in both eyes
* Documented history of fast progressing myopia, either in SER or AL
* SER progression: 0.50D/year or more
* AL elongation: 0.27mm/year or more
* For children aged 4-6 years without past prescription forms,
* 4-5 years old: myopia of -0.75D or below in both eyes
* 6 years old: myopia of -1.25D or below in at least one eye, with the other eye -0.75D or below
* Best-corrected visual acuity (VA) in both eyes:
* 4 - 6 years old: 0.20 logMAR (or its equivalent) or better
* 7-12 years old: 0.00 logMAR (or its equivalent) or better
* Acceptance of random group allocation and the masked study design
* Anisometropia of 1.50 D or less
* Astigmatism of 2.00 D or less
Exclusion Criteria:
* Strabismus and binocular vision abnormalities
* Ocular and systemic abnormalities
* Prior experience of myopia control
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
12 Years
Study:
NCT05888792
Study Brief:
Protocol Section:
NCT05888792