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Preterm Infants REtinalMicrovascular Alterations by Means of OCT Angiography (PREMA-OCTA)

Primary Purpose

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

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
OCT Angiography
Sponsored by
Centre Hospitalier Intercommunal Creteil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Premature With Dysplasia Bronchopulmonary

Eligibility Criteria

5 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: all groups 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

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

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

    patients in the control group without prematurity without BPD

    Arm Description

    OCT Angiography

    OCT Angiography

    OCT Angiography

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    To demonstrate differences in clinical parameters (visual acuity, spherical equivalent) between premature children (born ≤ 28 SA) and control children (born > 38SA)
    Collection of clinical parameters
    To demonstrate differences in OCT-A parameters (fractal dimension), between premature children (born ≤ 28 SA) and control children (born > 38SA)
    Collection of clinical parameters
    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.
    Collection of neonatal history
    To demonstrate differences in OCT-A parameters (central avascular zone area (mm2), between premature children (born ≤ 28 SA) and control children (born > 38SA)
    Collection of OCT angiography parameters

    Full Information

    First Posted
    December 14, 2022
    Last Updated
    June 12, 2023
    Sponsor
    Centre Hospitalier Intercommunal Creteil
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05699668
    Brief Title
    Preterm Infants REtinalMicrovascular Alterations by Means of OCT Angiography
    Acronym
    PREMA-OCTA
    Official Title
    Preterm Infants REtinalMicrovascular Alterations by Means of OCT Angiography
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 30, 2023 (Anticipated)
    Primary Completion Date
    July 31, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier Intercommunal Creteil

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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
    Detailed Description
    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 ischemia due to lack of vascular development. This lack of perfusion in the retinal periphery leads to abnormal secretion of pro-angiogenic factors, promoting the appearance of abnormal neovessels, which can be complicated by intravitreal hemorrhage and tractional retinal detachment, permanently altering vision. Conversely, it is known that in premature infants, there is a smaller central avascular zone compared to full-term infants. This area of the retina, where 90% of the cones are concentrated, must be free of vascular structures to allow optimal vision. Prematurity is often associated with respiratory fragility. It often requires ventilatory support in the form of oxygen therapy, invasive (oro-tracheal intubation) or non-invasive, which causes reflex arteriolar vasoconstriction, aggravating the ischemia already present in the periphery. Clinically, after birth, ocular disorders are more frequently found in preterm infants: amblyopia and contrast vision disorders, ametropia, strabismus and optic nerve anomalies. It is questionable whether there are subclinical retinal vascular changes, detectable on Tomographie par Cohérence Optique-Angiography, associated with clinical differences. Indeed, Angiography-Tomographie par Cohérence Optique allows detection of changes in foveolar and peripapillary retinal microvascularization more sensitively than dilated fundus examination (detection of subclinical microvascular abnormalities), as has been demonstrated for many retinal pathologies; it thus participates in the diagnosis, monitoring, evaluation of therapeutic response and prognosis of many retinal Angiography Tomographie par Cohérence Optique is rapidly expanding in retinal vascular pathologies: it is a simple, rapid, reliable, noninvasive, and injection-free examination that allows high-resolution study of the retinal vasculature, with a distinct analysis of the retinal plexuses and the choriocapillaris. It would also be interesting to investigate whether there is a correlation between the child's neonatal parameters, the retinal vascular changes on Angiography -Tomographie par Cohérence Optique, and the elements of the clinical examination (vision and refraction). If such a correlation is found, it would allow a targeted and personalized visual screening of the subjects identified as most at risk, with a stratification of the ocular risk according to the neonatal history and the OCT-A measurements. Finally, this study would provide a better understanding of the development of the retina during the neonatal period, the factors that may influence it, and the mechanisms potentially responsible for the observed disorders.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Premature With Dysplasia Bronchopulmonary, Premature Without Dysplasia Bronchopulmonary, Controls Born at Term

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    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
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    56 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    older premature children born at a term ≤28 weeks of amenorrhea without dysplasia bronchopulmonary
    Arm Type
    Experimental
    Arm Description
    OCT Angiography
    Arm Title
    older premature children born at a term ≤28 weeks of amenorrhea with dysplasia bronchopulmonary
    Arm Type
    Experimental
    Arm Description
    OCT Angiography
    Arm Title
    patients in the control group without prematurity without BPD
    Arm Type
    Experimental
    Arm Description
    OCT Angiography
    Intervention Type
    Device
    Intervention Name(s)
    OCT Angiography
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    To show a difference on vascular density in OCT-A (%), between preterm children (born ≤ 28 SA) and control children (born > 38SA).
    Description
    Macular and peripapillary vascular densities (%):on OCT-A images at the superficial and deep capillary plexus in the control and preterm groups
    Time Frame
    1day
    Secondary Outcome Measure Information:
    Title
    To demonstrate differences in clinical parameters (visual acuity, spherical equivalent) between premature children (born ≤ 28 SA) and control children (born > 38SA)
    Description
    Collection of clinical parameters
    Time Frame
    1 day
    Title
    To demonstrate differences in OCT-A parameters (fractal dimension), between premature children (born ≤ 28 SA) and control children (born > 38SA)
    Description
    Collection of clinical parameters
    Time Frame
    1 day
    Title
    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.
    Description
    Collection of neonatal history
    Time Frame
    1 day
    Title
    To demonstrate differences in OCT-A parameters (central avascular zone area (mm2), between premature children (born ≤ 28 SA) and control children (born > 38SA)
    Description
    Collection of OCT angiography parameters
    Time Frame
    1 day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: all groups 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Camille JUNG
    Phone
    00157022268
    Email
    camille.jung@chicreteil.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Cyndie Nilusmas
    Email
    cyndie.nilusmas@chicreteil.fr

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Preterm Infants REtinalMicrovascular Alterations by Means of OCT Angiography

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