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:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07394556
Eligibility Criteria:
Inclusion Criteria:
* Be aged between 6 to 12 completed years (6 and 12 years inclusive), irrespective of gender.
* For each group, an equal balance of gender will be recruited and 50% of children will be aged between 6- 9 years old and 50% aged 10-12 years old.
* Be cycloplegic autorefraction spherical component -0.50 D to -6.00D, cylinder no more than -2.00D, and with a spherical equivalent greater than or equal to -6.00D.
* Be accompanied by parents/guardians who can read and comprehend give informed consent as demonstrated by signing a record of informed consent.
* Be willing to comply with the wearing and clinical trial visit schedule as directed by the Investigator.
* Have ocular health findings considered to be "normal".
* Be correctable to at least 6/9.5 (20/30) or better in each eye with spectacles.
* Be willing to wear the spectacles provided by the investigators for all waking hours.
Exclusion Criteria:
* A known allergy to, or a history of intolerance to cyclopentolate or topical anesthetics.
* Had strabismus and/or amblyopia.
* Cylinder more than -2.00D
* Anisometropia greater than 1.50D spherical equivalent
* Had previous eye surgery (including strabismus surgery).
* Any ocular, systemic or other condition or disease with possible associations with myopia or affecting refractive development e.g. Marfan syndrome, retinopathy of prematurity, diabetes.
* Had any ocular injury or condition (including keratoconus and herpes keratitis) of the cornea, conjunctiva or eyelids.
* Current orthoptic treatment or vision training.
* Any anatomical, skin or other condition that would impact on the wearing of spectacles.
* Use of or need for concurrent category S3 and above ocular medication at enrolment and/or during the clinical trial.
* Currently enrolled in another clinical trial.
* No previous myopia management intervention or treatment.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
12 Years
Study:
NCT07394556
Study Brief:
Protocol Section:
NCT07394556