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 @ 5:41 PM
Ignite Modification Date:
2025-12-24 @ 5:41 PM
NCT ID:
NCT05699668
Eligibility Criteria:
Inclusion Criteria:
Premature group:
\- Any child aged 5 to 15 years born before or at 28 SA (with or without BPD), followed or not at the Creteil's hospital intercommunal
Control group:
* Any child aged 5 to 15 years born ≥ 38SA, consulting ophthalmology at the Creteil 's hospital intercommunal.
* Acceptance to participate in the protocol
* Child living near the Creteil's intercommunal hospital
* Affiliated to a social security system
Exclusion Criteria: all groups
* Neurobehavioral disorder or psychomotor delay that does not allow the examination to be performed
* Presence of a POR with zone I involvement or having received IVT of anti-VEGF (as it may directly modify the OCT-A parameters)
* Pre-existing retinal pathology: macular scarring of any etiology, retinal vascular alterations such as sickle cell disease, diabetes.
* Pre-existing optic nerve pathologies: glaucoma, coloboma, tumors.
* Chronic respiratory pathologies other than BPD (i.e. not associated with prematurity): cystic fibrosis, DDB...
* General pathology unrelated to prematurity that may have a retinal impact: e.g. respiratory diseases other than BPD
* Participation in an interventional study in ophthalmology
* A history of hyperthermic convulsions in infants or epilepsy, which contraindicates the use of eye drops.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
15 Years
Study:
NCT05699668
Study Brief:
Protocol Section:
NCT05699668