OCTA Evaluation of Retinal Vascularization in Preterm Infants With or Without Bronchopulmonary Dysplasia

Starting soon · Not applicable

Conditions studied: Bronchopulmonary Dysplasia

In brief

Retinal vascularization in humans develops between the 16th and 36th weeks of amenorrhea, in a centrifugal pattern starting from the optic disc. In the case of premature birth, the immature peripheral retina is at risk of ischemia due to incomplete vascular development. Prematurity is often associated with respiratory fragility. It frequently requires ventilatory support in the form of oxygen therapy, either invasive (orotracheal intubation) or non-invasive, which induces reflex arteriolar vasoconstriction, thereby worsening the existing ischemia. This raises the question of whether subclinical retinal vascular changes, detectable by OCT angiography, may explain the increased risk of amblyopia and the need for optical correction observed in these patients. OCT angiography is rapidly expanding in the field of retinal vascular diseases: it is a simple, fast, reliable, and non-invasive examination, requiring no injection, that enables high-resolution visualization of retinal vascularization, with separate analysis of the retinal plexuses and the choriocapillaris.

Key facts

Study ID

NCT07586683

Run by

Centre Hospitalier Intercommunal Creteil

People needed

56

Starts

2026-06-01

Expected to finish

2028-05-01

Last updated by the study team

2026-06-15

Who can join

Age: 5 and older, up to 15. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Preterm group:
• Any child aged 5 to 15 years born at or before 28 weeks' gestation (with or without bronchopulmonary dysplasia), followed or not at CHIC.
• Control group: Any child aged 5 to 15 years born at or after 38 weeks' gestation, attending ophthalmology consultations at CHIC.
• Agreement to participate in the study protocol
• Child living near CHI Créteil
• Enrolled in a social security scheme

You may not qualify if…

• Neurobehavioral disorders or psychomotor delay preventing the examination from being performed
• Presence of ROP (retinopathy of prematurity) involving zone I or having received intravitreal injections (IVT) of anti-VEGF (as this may directly alter OCT-A parameters)
• Pre-existing retinal disease: macular scar of any cause, retinal vascular abnormalities such as sickle cell disease or diabetes
• Pre-existing optic nerve diseases: glaucoma, coloboma, tumors
• Chronic respiratory diseases other than BPD (bronchopulmonary dysplasia) (i.e., not associated with prematurity): cystic fibrosis, bronchiectasis, etc.
• General condition unrelated to prematurity that may have a retinal impact: for example respiratory diseases other than BPD
• Participation in an interventional ophthalmology study
• History of febrile seizures in infancy or epilepsy contraindicating the use of eye drops

Where it is running

• Centre Hospitalier Intercommunal de Créteil — Créteil, France

Full record on ClinicalTrials.gov

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