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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07586683
Acronym
OCTA_BRO
Enrollment
56
Registered
2026-05-14
Start date
2026-05-01
Completion date
2028-05-01
Last updated
2026-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchopulmonary Dysplasia

Keywords

OCT_A, children born prematurely, Bronchopulmonary dysplasia

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.

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.

Interventions

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

Sponsors

Centre Hospitalier Intercommunal Creteil
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
5 Years to 15 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 1Macular 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

Secondary

MeasureTime frameDescription
Evaluation of retinal vascular density using OCT-A in preterm and term-born childrenDay 1Percentage (%) of retinal vascular density measured on OCT-A images in preterm and term-born children.
Foveal avascular zone areaDay 1Area of the foveal avascular zone measured on OCT-A images, expressed in mm².
Fractal dimension on OCT-A imagesDay1Fractal dimension calculated from OCT-A retinal vascular images.
Best-corrected visual acuityDay1Best-corrected visual acuity assessed using the Snellen scale.
Visual acuity (Snellen scale) with correction Spherical equivalent (SE)Day1Spherical equivalent calculated as: SE = S + ½ C

Countries

France

Contacts

CONTACTSamia SERAY, Dr
samia.seray@chicreteil.fr01 57 02 20 00/8122
PRINCIPAL_INVESTIGATORSamia SERAY, Dr

Centre Hospitalier intercommunal de Créteil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 15, 2026