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

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ClinicalTrials.gov Identifier: NCT05699668
Recruitment Status : Not yet recruiting
First Posted : January 26, 2023
Last Update Posted : February 15, 2023
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Intercommunal Creteil

Tracking Information
First Submitted Date  ICMJE December 14, 2022
First Posted Date  ICMJE January 26, 2023
Last Update Posted Date February 15, 2023
Estimated Study Start Date  ICMJE March 15, 2023
Estimated Primary Completion Date July 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 16, 2023)
To show a difference on vascular density in OCT-A (%), between preterm children (born ≤ 28 SA) and control children (born > 38SA). [ Time Frame: 1day ]
Macular and peripapillary vascular densities (%):on OCT-A images at the superficial and deep capillary plexus in the control and preterm groups
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 16, 2023)
  • To demonstrate differences in clinical parameters (visual acuity, spherical equivalent) between premature children (born ≤ 28 SA) and control children (born > 38SA) [ Time Frame: 1 day ]
    Collection of clinical parameters
  • To demonstrate differences in OCT-A parameters (fractal dimension), between premature children (born ≤ 28 SA) and control children (born > 38SA) [ Time Frame: 1 day ]
    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. [ Time Frame: 1 day ]
    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) [ Time Frame: 1 day ]
    Collection of OCT angiography parameters
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preterm Infants REtinalMicrovascular Alterations by Means of OCT Angiography
Official Title  ICMJE Preterm Infants REtinalMicrovascular Alterations by Means of OCT Angiography
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Other
Condition  ICMJE
  • Premature With Dysplasia Bronchopulmonary
  • Premature Without Dysplasia Bronchopulmonary
  • Controls Born at Term
Intervention  ICMJE Device: OCT Angiography

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.

Study Arms  ICMJE
  • Experimental: older premature children born at a term ≤28 weeks of amenorrhea without dysplasia bronchopulmonary
    OCT Angiography
    Intervention: Device: OCT Angiography
  • Experimental: older premature children born at a term ≤28 weeks of amenorrhea with dysplasia bronchopulmonary
    OCT Angiography
    Intervention: Device: OCT Angiography
  • Experimental: patients in the control group without prematurity without BPD
    OCT Angiography
    Intervention: Device: OCT Angiography
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 16, 2023)
56
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2023
Estimated Primary Completion Date July 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Camille JUNG 00157022268 camille.jung@chicreteil.fr
Contact: Cyndie Nilusmas cyndie.nilusmas@chicreteil.fr
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05699668
Other Study ID Numbers  ICMJE PREMA-OCTA
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Centre Hospitalier Intercommunal Creteil
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Centre Hospitalier Intercommunal Creteil
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Centre Hospitalier Intercommunal Creteil
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP