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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Bronchopulmonary Dysplasia
• Intervention / Treatment: Device: OCT Angiography

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Samia SERAY, Dr; Phone Number: 01 57 02 20 00/8122; Email: samia.seray@chicreteil.fr

Study Locations

• France
  • Créteil, France, 94000
    • Centre Hospitalier Intercommunal de Créteil
    • Contact: Samia SERAY, Dr; Phone Number: 01 57 02 20 00/8122; Email: samia.seray@chicreteil.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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	Device: OCT Angiography; OCTA evaluation of retinal vascularization in preterm infants with or without bronchopulmonary dysplasia.
Other: 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	Device: OCT Angiography; OCTA evaluation of retinal vascularization in preterm infants with or without bronchopulmonary dysplasia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal Creteil
• Investigators: Principal Investigator: Samia SERAY, Dr, Centre Hospitalier Intercommunal de Créteil

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: April 17, 2026
• First Submitted That Met QC Criteria: May 7, 2026
• First Posted (Actual): May 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Bronchopulmonary dysplasia; OCT_A; children born prematurely
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Lung Injury; Ventilator-Induced Lung Injury; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Bronchopulmonary Dysplasia
• Other Study ID Numbers: OCTA_BRO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No