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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-15
SponsorCentre Hospitalier Intercommunal Creteil

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Agreement to participate in the study protocol

Child living near CHI Créteil

Enrolled in a social security scheme

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • OCT Angiography

    Device

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

Treatment groups

56 Participants
are divided into 2 treatment groups
Group A: former preterm children bornOther 1 intervention
Group B: 28 childrens in the control groupOther 1 intervention

Trial outcomes

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 "percent" based on OCT-A images of the superficial and deep capillary plexuses in the control group of children and the preterm infant group

Time frame
Day 1

Secondary outcomes

1

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

percent of retinal vascular density measured on OCT-A images in preterm and term-born children.

Time frame
Day 1
2

Foveal avascular zone area

Area of the foveal avascular zone measured on OCT-A images, expressed in mm².

Time frame
Day 1
3

Fractal dimension on OCT-A images

Fractal dimension calculated from OCT-A retinal vascular images.

Time frame
Day1
4

Best-corrected visual acuity

Best-corrected visual acuity assessed using the Snellen scale.

Time frame
Day1

Other outcomes

Sponsors and contacts

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