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 @ 11:30 PM
Ignite Modification Date:
2025-12-24 @ 11:30 PM
NCT ID:
NCT02241356
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with Down syndrome (DS)
* Accommodation lag \>0.5 Dioptres for children with DS \<12 years and \>0.75 Dioptres for children older than age 12 or Visual acuity at near is worse than at distance and \>0.1
* Age range 2-14 years
* Speaks Dutch as the first language
* Must be verbal or able to understand instructions
* Must be able to perform a task sitting on a chair and working at a table
Exclusion Criteria:
* Visual acuity at near \< 0.1
* Not able to do vision tests at age over 5
* Has worn bifocals already
* Other significant eye diseases, such as keratoconus, cataract or high myopia (\>S-6.00).
* Diagnoses of any neurological, sensory or behavioural disorders such as autism, microcephaly or significant hearing loss.
* Prematurity, born premature after a pregnancy term less than 36 weeks
* Born after severe perinatal problems
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
14 Years
Study:
NCT02241356
Study Brief:
Protocol Section:
NCT02241356