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

NCT07586683 · tracked via the Priya Life Science France tracker

Sponsor

Centre Hospitalier Intercommunal Creteil

Phase

Not applicable

Started

2026-06

Last updated

2026-06-15

Condition(s) studied

Bronchopulmonary Dysplasia

Investigational drug(s) / intervention(s)

OCT Angiography

OCT Angiography: OCTA evaluation of retinal vascularization in preterm infants with or without bronchopulmonary dysplasia.

Study summary

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.

Eligibility

Sex

ALL

Min age

5 Years

Max age

15 Years

Healthy volunteers

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

Highlight a difference in vascular density on OCT-A (%), between preterm infants (born ≤ 28 weeks of gestational age) and control infants (born > 38 weeks of gestational age) — Day 1
Macular and peripapillary vascular densities "percent" based on OCT-A images of the superficial and deep capillary plexuses in the control group of children and the preterm infant group

Trial sites (1)

Facility	City	Region	Status
Centre Hospitalier Intercommunal de Créteil	Créteil	France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07586683 on ClinicalTrials.gov ↗ ← All trials in France