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NCT05699668
Preterm Infants REtinalMicrovascular Alterations by Means of OCT Angiography
Conditions: Premature Birth With Dysplasia Bronchopulmonary, Premature Birth Without Dysplasia Bronchopulmonary, Controls Born at Term
Sex: All
Ages: 5 Years – 15 Years
Phase: NA
Enrollment: 56
Sponsor: Centre Hospitalier Intercommunal Creteil
Summary
Retinal vascularization in humans develops between the 16th and 36th week of amenorrhea, centrifugally from the papilla.
In case of premature birth, the immature retinal periphery is at risk of ischemic damage due to lack of vascular development.Prematurity is often associated with respiratory fragility.
It often requires ventilatory assistance in the form of oxygen therapy, invasive (oro-tracheal intubation) or non-invasive, which leads to reflex arteriolar vasoconstriction aggravating the ischemia already present.
One may wonder if there are subclinical retinal vascular changes, detectable on Tomographie par Cohérence Optique-Angiography (, that could explain the greater risk of amblyopia and optical correction observed.
Tomographie par Cohérence Optique-Angiography is a fast growing technique in retinal vascular pathologies: it is a simple, fast, reliable, non-invasive, injection-free examination, which allows to study in high resolution the retinal vascularization, with a distinct analysis of the retinal plexuses and the choriocapillaris
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 intercommunalControl group:Any child aged 5 to 15 years born ≥ 38SA, consulting ophthalmology at the Creteil 's hospital intercommunal.Acceptance to participate in the protocolChild living near the Creteil's intercommunal hospitalAffiliated to a social security systemExclusion Criteria: all groupsNeurobehavioral disorder or psychomotor delay that does not allow the examination to be performedPresence 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 BPDParticipation in an interventional study in ophthalmologyA history of hyperthermic convulsions in infants or epilepsy, which contraindicates the use of eye drops.
Source: ClinicalTrials.gov (NCT05699668). StuddyBuddy aggregates publicly available trial information.