Preterm Infants REtinalMicrovascular Alterations by Means of OCT Angiography

NCT05699668 | Unknown

• 1 other identifier: PREMA-OCTA
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief Summary

Retinal vascularization in humans develops between the 16th and 36th week of amenorrhea, centrifugally from the papilla. In case of premature birth, the immature retinal periphery is at risk of ischemic damage due to lack of vascular development. Prematurity is often associated with respiratory fragility. It often requires ventilatory assistance in the form of oxygen therapy, invasive (oro-tracheal intubation) or non-invasive, which leads to reflex arteriolar vasoconstriction aggravating the ischemia already present. One may wonder if there are subclinical retinal vascular changes, detectable on Tomographie par Cohérence Optique-Angiography (, that could explain the greater risk of amblyopia and optical correction observed. Tomographie par Cohérence Optique-Angiography is a fast growing technique in retinal vascular pathologies: it is a simple, fast, reliable, non-invasive, injection-free examination, which allows to study in high resolution the retinal vascularization, with a distinct analysis of the retinal plexuses and the choriocapillaris

Conditions

Premature With Dysplasia Bronchopulmonary; Premature Without Dysplasia Bronchopulmonary; Controls Born at Term

Outcome Measures

Primary Outcomes (1)

• To show a difference on vascular density in OCT-A (%), between preterm children (born ≤ 28 SA) and control children (born > 38SA).

  Macular and peripapillary vascular densities (%):on OCT-A images at the superficial and deep capillary plexus in the control and preterm groups

  1day

Secondary Outcomes (4)

• To demonstrate differences in clinical parameters (visual acuity, spherical equivalent) between premature children (born ≤ 28 SA) and control children (born > 38SA)

  1 day

• To demonstrate differences in OCT-A parameters (fractal dimension), between premature children (born ≤ 28 SA) and control children (born > 38SA)

  1 day

• To demonstrate a correlation between neonatal history (term, birth weight, duration of oxygen therapy, ventilation mode, presence or absence of BPD), clinical parameters (visual acuity, spherical equivalent), and OCT-A parameters.

  1 day

• To demonstrate differences in OCT-A parameters (central avascular zone area (mm2), between premature children (born ≤ 28 SA) and control children (born > 38SA)

  1 day

Study Arms (3)

older premature children born at a term ≤28 weeks of amenorrhea without dysplasia bronchopulmonary

EXPERIMENTAL

OCT Angiography

Device: OCT Angiography

older premature children born at a term ≤28 weeks of amenorrhea with dysplasia bronchopulmonary

EXPERIMENTAL

OCT Angiography

Device: OCT Angiography

patients in the control group without prematurity without BPD

EXPERIMENTAL

OCT Angiography

Device: OCT Angiography

Interventions

OCT Angiography DEVICE

2 views per eye (one centered on the fovea, one centered on the optic nerve), in 6x6 mm, using the OCT-A Plexelite®. Acquisition time per image: about 10 seconds.

older premature children born at a term ≤28 weeks of amenorrhea with dysplasia bronchopulmonary; older premature children born at a term ≤28 weeks of amenorrhea without dysplasia bronchopulmonary; patients in the control group without prematurity without BPD

Eligibility Criteria

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

You may qualify if:

• Premature group:
• \- Any child aged 5 to 15 years born before or at 28 SA (with or without BPD), followed or not at the Creteil's hospital intercommunal
• Control group:
• Any child aged 5 to 15 years born ≥ 38SA, consulting ophthalmology at the Creteil 's hospital intercommunal.
• Acceptance to participate in the protocol
• Child living near the Creteil's intercommunal hospital
• Affiliated to a social security system

You may not qualify if:

• Neurobehavioral disorder or psychomotor delay that does not allow the examination to be performed
• Presence of a POR with zone I involvement or having received IVT of anti-VEGF (as it may directly modify the OCT-A parameters)
• Pre-existing retinal pathology: macular scarring of any etiology, retinal vascular alterations such as sickle cell disease, diabetes.
• Pre-existing optic nerve pathologies: glaucoma, coloboma, tumors.
• Chronic respiratory pathologies other than BPD (i.e. not associated with prematurity): cystic fibrosis, DDB...
• General pathology unrelated to prematurity that may have a retinal impact: e.g. respiratory diseases other than BPD
• Participation in an interventional study in ophthalmology
• A history of hyperthermic convulsions in infants or epilepsy, which contraindicates the use of eye drops.

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead

Central Study Contacts

Camille JUNG

CONTACT

00157022268; camille.jung@chicreteil.fr

Cyndie Nilusmas

CONTACT

cyndie.nilusmas@chicreteil.fr

Study Design

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

Model Details: Premature infants born at a term ≤28 weeks of amenorrhea, without bronchopulmonary dysplasia (BPD), whether or not followed at CHIC Premature infants born at a term ≤28 weeks of amenorrhea, with bronchopulmonary dysplasia (BPD) and followed or not at CHIC Patients in the control group (without prematurity without BPD) selected at a scheduled routine ophthalmology consultation at CHIC, born at a term ≥ 38SA

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: January 26, 2023
• Study Start: June 30, 2023
• Primary Completion: July 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 13, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share