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

11 juin 2026 mis à jour par: Centre Hospitalier Intercommunal Creteil

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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Intervention / Traitement

Description détaillée

Retinal vascularization in humans develops between the 16th and 36th weeks of gestational age, progressing centrifugally from the optic disc. In the case of premature birth, the immature peripheral retina is at risk of ischemia due to incomplete vascular development. This lack of perfusion in the retinal periphery leads to abnormal secretion of pro-angiogenic factors, promoting the formation of abnormal neovessels, which may be complicated by vitreous hemorrhage and tractional retinal detachment, resulting in permanent visual impairment.

Conversely, it is known that premature infants have a smaller central avascular zone compared with full-term infants. This region of the retina, where 90% of cones are concentrated, must remain free of vascular structures to allow optimal vision.

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 and worsens the ischemia already present in the periphery.

Clinically, after birth, ocular disorders are more frequently observed in premature children, including amblyopia, impaired contrast sensitivity, refractive errors, strabismus, and optic nerve abnormalities.

It is therefore reasonable to question whether subclinical retinal vascular changes exist, detectable by OCT angiography, and associated with these clinical differences.

Indeed, OCT-A makes it possible to detect changes in foveal and peripapillary retinal microvascularization more sensitively than dilated fundus examination (allowing detection of subclinical microvascular abnormalities), as has been demonstrated in numerous retinal diseases. It thus contributes to diagnosis, follow-up, assessment of therapeutic response, and prognosis in many retinal pathologies.

OCT angiography is rapidly expanding in the field of retinal vascular diseases: it is a simple, quick, reliable, non-invasive, dye-free examination that enables high-resolution study of retinal vasculature, with separate analysis of the retinal plexuses and the choriocapillaris.

It would also be of interest to investigate whether there is a correlation between neonatal parameters, retinal vascular changes observed on OCT-A, and clinical findings (vision and refraction). If such a correlation is demonstrated, it could enable targeted and personalized visual screening of individuals identified as being at highest risk, with stratification of ocular risk based on neonatal history and OCT-A measurements.

Finally, such a study would improve our understanding of retinal development during the neonatal period, the factors that may influence it, and the mechanisms potentially responsible for the observed disorders.

Type d'étude

Interventionnel

Inscription (Estimé)

56

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

      • Créteil, France, 94000
        • Centre Hospitalier Intercommunal de Créteil
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Autre: former preterm children born
14 former preterm children born at ≤28 weeks of gestational age, without bronchopulmonary dysplasia (BPD), followed or not at CHIC 14 preterm children born at ≤28 weeks of gestational age, with BPD, followed or not at CHIC
OCTA evaluation of retinal vascularization in preterm infants with or without bronchopulmonary dysplasia.
Autre: 28 childrens in the control group
28 childrens in the control group (no prematurity, no BPD), selected during a routine ophthalmology consultation scheduled at CHIC, born at ≥38 weeks of gestational age
OCTA evaluation of retinal vascularization in preterm infants with or without bronchopulmonary dysplasia.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
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)
Délai: 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
Day 1

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Foveal avascular zone area
Délai: Day 1
Area of the foveal avascular zone measured on OCT-A images, expressed in mm².
Day 1
Fractal dimension on OCT-A images
Délai: Day1
Fractal dimension calculated from OCT-A retinal vascular images.
Day1
Best-corrected visual acuity
Délai: Day1
Best-corrected visual acuity assessed using the Snellen scale.
Day1
Visual acuity (Snellen scale) with correction Spherical equivalent (SE)
Délai: Day1
Spherical equivalent calculated as: SE = S + ½ C
Day1
Evaluation of retinal vascular density using OCT-A in preterm and term-born children
Délai: Day 1
percent of retinal vascular density measured on OCT-A images in preterm and term-born children.
Day 1

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Samia SERAY, Dr, Centre Hospitalier Intercommunal de Créteil

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juin 2026

Achèvement primaire (Estimé)

1 mai 2028

Achèvement de l'étude (Estimé)

1 mai 2028

Dates d'inscription aux études

Première soumission

17 avril 2026

Première soumission répondant aux critères de contrôle qualité

7 mai 2026

Première publication (Réel)

14 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

15 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

11 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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