Premature With Dysplasia BronchopulmonaryPREMA-OCTANCT05699668
Preterm Infants REtinalMicrovascular Alterations by Means of OCT Angiography
A study testing OCT Angiography in people with Premature With Dysplasia Bronchopulmonary and Premature Without Dysplasia Bronchopulmonary, run by Centre Hospitalier Intercommunal Creteil.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Premature With Dysplasia Bronchopulmonary, Premature Without Dysplasia Bronchopulmonary, Controls Born at Term
- What is being tested?
- OCT Angiography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
About this study
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.
- Conditions
- Premature With Dysplasia Bronchopulmonary, Premature Without Dysplasia Bronchopulmonary, Controls Born at Term
- Being tested
- OCT Angiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT AngiographyDevice
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 group | Role | What they receive |
|---|---|---|
| older premature children born at a term ≤28 weeks of amenorrhea without dysplasia bronchopulmonary | Experimental | OCT Angiography Receives: Device: OCT Angiography |
| older premature children born at a term ≤28 weeks of amenorrhea with dysplasia bronchopulmonary | Experimental | OCT Angiography Receives: Device: OCT Angiography |
| patients in the control group without prematurity without BPD | Experimental | OCT Angiography Receives: Device: OCT Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Collection of clinical parameters
Measured: 1 day
To demonstrate differences in OCT-A parameters (fractal dimension), between premature children (born ≤ 28 SA) and control children (born > 38SA)
Collection of clinical parameters
Measured: 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.
Collection of neonatal history
Measured: 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)
Collection of OCT angiography parameters
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start30 Jun 2023 (estimated)
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Why it stopped: As no participants were enrolled within two years of the favorable CPP opinion, the opinion has become void.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature With Dysplasia BronchopulmonaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05699668
- Sponsor's protocol ID
- PREMA-OCTA
- Acronym
- PREMA-OCTA
- Status last verified
- Jun 2026
- First submitted
- 14 Dec 2022
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preterm Infants REtinalMicrovascular Alterations by Means of OCT Angiography
- ClinicalTrials.gov ID
- NCT05699668
- Acronym / sponsor ID
- PREMA-OCTA / PREMA-OCTA
- Conditions
- Premature With Dysplasia Bronchopulmonary, Premature Without Dysplasia Bronchopulmonary, Controls Born at Term
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: As no participants were enrolled within two years of the favorable CPP opinion, the opinion has become void.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- 30 Jun 2023 (estimated)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| older premature children born at a term ≤28 weeks of amenorrhea without dysplasia bronchopulmonary | Experimental | Device: OCT AngiographyOCT Angiography |
| older premature children born at a term ≤28 weeks of amenorrhea with dysplasia bronchopulmonary | Experimental | Device: OCT AngiographyOCT Angiography |
| patients in the control group without prematurity without BPD | Experimental | Device: OCT AngiographyOCT Angiography |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
- 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
Key exclusion criteria (8 listed)
- 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...
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCT Angiography2 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. | Device | 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 |
Primary outcome
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
4 secondary outcomes
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
To demonstrate differences in OCT-A parameters (fractal dimension), between premature children (born ≤ 28 SA) and control children (born > 38SA)
Time frame: 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.
Time frame: 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)
Time frame: 1 day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing OCT Angiography in people with Premature With Dysplasia Bronchopulmonary and Premature Without Dysplasia Bronchopulmonary, run by Centre Hospitalier Intercommunal Creteil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To show a difference on vascular density in OCT-A (%), between preterm children (born ≤ 28 SA) and control children (born > 38SA). (time frame: 1day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.