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

11 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

56

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

      • Créteil, Francia, 94000
        • Centre Hospitalier Intercommunal de Creteil
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: 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.
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Foveal avascular zone area
Lasso di tempo: Day 1
Area of the foveal avascular zone measured on OCT-A images, expressed in mm².
Day 1
Fractal dimension on OCT-A images
Lasso di tempo: Day1
Fractal dimension calculated from OCT-A retinal vascular images.
Day1
Best-corrected visual acuity
Lasso di tempo: Day1
Best-corrected visual acuity assessed using the Snellen scale.
Day1
Visual acuity (Snellen scale) with correction Spherical equivalent (SE)
Lasso di tempo: Day1
Spherical equivalent calculated as: SE = S + ½ C
Day1
Evaluation of retinal vascular density using OCT-A in preterm and term-born children
Lasso di tempo: Day 1
percent of retinal vascular density measured on OCT-A images in preterm and term-born children.
Day 1

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Samia SERAY, Dr, Centre Hospitalier Intercommunal de Creteil

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

1 maggio 2028

Completamento dello studio (Stimato)

1 maggio 2028

Date di iscrizione allo studio

Primo inviato

17 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

7 maggio 2026

Primo Inserito (Effettivo)

14 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

15 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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