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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
OCT Angiography
DeviceOCTA evaluation of retinal vascularization in preterm infants with or without bronchopulmonary dysplasia.
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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.
Foveal avascular zone area
Area of the foveal avascular zone measured on OCT-A images, expressed in mm².
Fractal dimension on OCT-A images
Fractal dimension calculated from OCT-A retinal vascular images.
Best-corrected visual acuity
Best-corrected visual acuity assessed using the Snellen scale.
Sponsors and contacts
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