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 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT05617794
Eligibility Criteria:
Inclusion Criteria:
* Are 8-14 years of age;
* Are able to read (or be read to), understand and sign the assent document;
* Are accompanied by a parent or legal guardian who is able to read, understand and sign the parental information and permission document;
* Are emmetropic by non-cycloplegic auto-refraction, which means both refractive meridians should be within +1.00D and -1.00D inclusively;
* Are willing and able to follow instructions.
Exclusion Criteria:
* Are participating in any concurrent interventional clinical or research study;
* Have a history of myopia control treatment in the past year;
* Have amblyopia in either eye or known to have any other binocular vision disorder, such as accommodative insufficiency;
* Have any known active ocular disease and/or infection;
* Have a systemic condition that in the opinion of the investigator may affect a study outcome variable. Examples include diabetes mellitus, hyperthyroidism;
* Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable. Examples include Atropine eye drops;
* Have undergone strabismus surgery, refractive error surgery or intraocular surgery;
* Are a child of a member of the study team.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
14 Years
Study:
NCT05617794
Study Brief:
Protocol Section:
NCT05617794