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 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 1:17 AM
NCT ID:
NCT04740593
Eligibility Criteria:
Inclusion Criteria:
* Registered at one of the participating CHCs;
* 12-18 months of age;
* Voluntary approval for participation by the parents or legal representative/guardian with provided written informed consent;
* Willingness of the parents/guardian(s) to comply with the study procedures
Exclusion Criteria:
* Congenital syndromes;
* Psychomotor retardation;
* Known hereditary defects;
* Known cardiac disease;
* Severe comorbidity;
* Children's whose parents do not agree to cyclopegia with the use of cyclopentolate 1% eye drops for orthoptic examination (retinacopy) by the study orthoptist;
* Refractive error higher than the AAPOS criteria twofold (i.e. hyperopia \>7 dioptres, anisometropia \>3 dioptres and astigmatism of \>3 dioptres at 90º or 180º and \>2 dioptres in oblique axis (\>10º eccentric to 90º or 180º);
* Strabismus;
* Amblyopia;
* Ptosis;
* Cataract or other media opacity;
* Other ophthalmic disease requiring immediate referral;
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Months
Maximum Age:
18 Months
Study:
NCT04740593
Study Brief:
Protocol Section:
NCT04740593