CClinicalTrials.gg
WithdrawnNCT05699668PREMA-OCTAUpdated Jun 15, 2026

Preterm Infants REtinalMicrovascular Alterations by Means of OCT Angiography

An interventional study of OCT Angiography in Premature With Dysplasia Bronchopulmonary, Premature Without Dysplasia Bronchopulmonary and Controls Born at Term, sponsored by Centre Hospitalier Intercommunal Creteil. Withdrawn. Open to participants aged 5 Years to 15 Years. Per ClinicalTrials.gov, last updated 2026-06-15.

Sponsored by Centre Hospitalier Intercommunal Creteil · Not applicable, Interventional, and Other

Why this study was withdrawn
As no participants were enrolled within two years of the favorable CPP opinion, the opinion has become void.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
5 Years to 15 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Premature With Dysplasia Bronchopulmonary
  • Premature Without Dysplasia Bronchopulmonary
  • Controls Born at Term
03

In context

Lead sponsor

Centre Hospitalier Intercommunal Creteil is the lead sponsor of 131 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 15 Years
Sexes eligible
All
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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

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

    OCT Angiography

    Device: OCT Angiography

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

    OCT Angiography

    Device: OCT Angiography

  • Experimental
    patients in the control group without prematurity without BPD

    OCT Angiography

    Device: OCT Angiography

Interventions

  • DeviceOCT 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.

06

What researchers measure

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

    Time frame: 1day

Secondary outcomes

  1. 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

    Time frame: 1 day

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

    Collection of clinical parameters

    Time frame: 1 day

  3. 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

    Time frame: 1 day

  4. 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

    Time frame: 1 day

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05699668
Lead sponsor
Centre Hospitalier Intercommunal Creteil
Responsible party
Sponsor
First posted
Jan 26, 2023
Start date
Jun 30, 2023 (estimated)
Primary completion
Jul 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Jun 15, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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