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 @ 6:50 PM
Ignite Modification Date:
2025-12-24 @ 6:50 PM
NCT ID:
NCT01942057
Eligibility Criteria:
Inclusion Criteria:
* Has had a parent/legal guardian read the study consent form and who agrees to allow them to participate in the study by signing the consent form
* Has had the "letter of assent for children" explained to them, the child has agreed to participate and the letter has been signed by the study investigator and the child
* Has provided the completed Questionnaire (Appendix 4A for parents to complete on behalf of their children in school grades 1 and 2, 6 and 7; Appendix 4B for children to complete that are in school grades 11 and 12)
* Is currently in school grades 1 and 2, 6 and 7 or 11 and 12
* Is willing and able to follow instructions and maintain the appointment schedule
Exclusion Criteria:
* Has not given verbal assent to participate
* Has known sensitivity to the diagnostic pharmaceuticals to be used in the study
* Has undergone refractive error surgery or orthokeratology
* Has serious medical disorders or eye diseases/abnormalities such as amblyopia and cataract or a cognitive inability to conduct the tests
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
18 Years
Study:
NCT01942057
Study Brief:
Protocol Section:
NCT01942057