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

NCT07586683 | Not Yet Recruiting

• 1 other identifier: OCTA_BRO
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bronchopulmonary Dysplasia

Keywords

OCT_A; children born prematurely; Bronchopulmonary dysplasia

Outcome Measures

Primary Outcomes (1)

• 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)

  Macular and peripapillary vascular densities (%) 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

Secondary Outcomes (5)

• Evaluation of retinal vascular density using OCT-A in preterm and term-born children

  Day 1

• Foveal avascular zone area

  Day 1

• Fractal dimension on OCT-A images

  Day1

• Best-corrected visual acuity

  Day1

• Visual acuity (Snellen scale) with correction Spherical equivalent (SE)

  Day1

Study Arms (2)

former preterm children born

OTHER

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

Device: OCT Angiography

28 childrens in the control group

OTHER

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

Device: OCT Angiography

Interventions

OCT Angiography DEVICE

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

28 childrens in the control group; former preterm children born

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead

Study Sites (1)

Centre Hospitalier Intercommunal de Créteil

Créteil, 94000, France

Location

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Samia SERAY, Dr

  Centre Hospitalier intercommunal de Créteil

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samia SERAY, Dr

CONTACT

01 57 02 20 00/8122; samia.seray@chicreteil.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study population is divided into three groups of children: * 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 * 28 patients in the control group (no prematurity, no BPD), selected during a routine ophthalmology consultation scheduled at CHIC, born at ≥38 weeks of gestational age

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: May 14, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: May 14, 2026

Record last verified: 2026-04

Locations

FR (1)