Bronchopulmonary DysplasiaOCTA_BRONCT07586683
OCTA Evaluation of Retinal Vascularization in Preterm Infants With or Without Bronchopulmonary Dysplasia
A study testing OCT Angiography in people with Bronchopulmonary Dysplasia, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
Trial summary
Retinal vascularization in humans develops between the 16th and 36th weeks of amenorrhea, in a centrifugal pattern starting from the optic disc. In the case of premature birth, the immature peripheral retina is at risk of ischemia due to incomplete vascular development. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Bronchopulmonary Dysplasia
- 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
- 56 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2026to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Preterm group:
- Any child aged 5 to 15 years born at or before 28 weeks' gestation (with or without bronchopulmonary dysplasia), followed or not at CHIC.
- -Control group: Any child aged 5 to 15 years born at or after 38 weeks' gestation, attending ophthalmology consultations at CHIC.
- Agreement to participate in the study protocol
- Child living near CHI Créteil
- Enrolled in a social security scheme
Who cannot join
- Neurobehavioral disorders or psychomotor delay preventing the examination from being performed
- Presence of ROP (retinopathy of prematurity) involving zone I or having received intravitreal injections (IVT) of anti-VEGF (as this may directly alter OCT-A parameters)
- Pre-existing retinal disease: macular scar of any cause, retinal vascular abnormalities such as sickle cell disease or diabetes
- Pre-existing optic nerve diseases: glaucoma, coloboma, tumors
- Chronic respiratory diseases other than BPD (bronchopulmonary dysplasia) (i.e., not associated with prematurity): cystic fibrosis, bronchiectasis, etc.
- General condition unrelated to prematurity that may have a retinal impact: for example respiratory diseases other than BPD
- Participation in an interventional ophthalmology study
- History of febrile seizures in infancy or epilepsy contraindicating the use of eye drops
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Centre Hospitalier Intercommunal de Créteil
Créteil, 94000
Samia SERAY, Dr, 01 57 02 20 00/8122, samia.seray@chicreteil.fr
About this study
Retinal vascularization in humans develops between the 16th and 36th weeks of amenorrhea, in a centrifugal pattern starting from the optic disc. In the case of premature birth, the immature peripheral retina is at risk of ischemia due to incomplete vascular development.
Prematurity is often associated with respiratory fragility. It frequently requires ventilatory support in the form of oxygen therapy, either invasive (orotracheal intubation) or non-invasive, which induces reflex arteriolar vasoconstriction, thereby worsening the existing ischemia. This raises the question of whether subclinical retinal vascular changes, detectable by OCT angiography, may explain the increased risk of amblyopia and the need for optical correction observed in these patients.
OCT angiography is rapidly expanding in the field of retinal vascular diseases: it is a simple, fast, reliable, and non-invasive examination, requiring no injection, that enables high-resolution visualization of retinal vascularization, with separate analysis of the retinal plexuses and the choriocapillaris.
Read the detailed description
Retinal vascularization in humans develops between the 16th and 36th weeks of gestational age, progressing centrifugally from the optic disc. In the case of premature birth, the immature peripheral retina is at risk of ischemia due to incomplete vascular development. This lack of perfusion in the retinal periphery leads to abnormal secretion of pro-angiogenic factors, promoting the formation of abnormal neovessels, which may be complicated by vitreous hemorrhage and tractional retinal detachment, resulting in permanent visual impairment.
Conversely, it is known that premature infants have a smaller central avascular zone compared with full-term infants. This region of the retina, where 90% of cones are concentrated, must remain free of vascular structures to allow optimal vision.
Prematurity is often associated with respiratory fragility. It frequently requires ventilatory support in the form of oxygen therapy, either invasive (orotracheal intubation) or non-invasive, which induces reflex arteriolar vasoconstriction and worsens the ischemia already present in the periphery.
Clinically, after birth, ocular disorders are more frequently observed in premature children, including amblyopia, impaired contrast sensitivity, refractive errors, strabismus, and optic nerve abnormalities.
It is therefore reasonable to question whether subclinical retinal vascular changes exist, detectable by OCT angiography, and associated with these clinical differences.
Indeed, OCT-A makes it possible to detect changes in foveal and peripapillary retinal microvascularization more sensitively than dilated fundus examination (allowing detection of subclinical microvascular abnormalities), as has been demonstrated in numerous retinal diseases. It thus contributes to diagnosis, follow-up, assessment of therapeutic response, and prognosis in many retinal pathologies.
OCT angiography is rapidly expanding in the field of retinal vascular diseases: it is a simple, quick, reliable, non-invasive, dye-free examination that enables high-resolution study of retinal vasculature, with separate analysis of the retinal plexuses and the choriocapillaris.
It would also be of interest to investigate whether there is a correlation between neonatal parameters, retinal vascular changes observed on OCT-A, and clinical findings (vision and refraction). If such a correlation is demonstrated, it could enable targeted and personalized visual screening of individuals identified as being at highest risk, with stratification of ocular risk based on neonatal history and OCT-A measurements.
Finally, such a study would improve our understanding of retinal development during the neonatal period, the factors that may influence it, and the mechanisms potentially responsible for the observed disorders.
- Conditions
- Bronchopulmonary Dysplasia
- Being tested
- OCT Angiography
- Keywords
- OCT_A, children born prematurely, Bronchopulmonary dysplasia
- Medical subject headings
- Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT AngiographyDevice
OCTA evaluation of retinal vascularization in preterm infants with or without bronchopulmonary dysplasia.
| Study group | Role | What they receive |
|---|---|---|
| former preterm children born | Other | 14 former preterm children born at ≤28 weeks of gestational age, without bronchopulmonary dysplasia (BPD), followed or not at CHIC 14 preterm children born at ≤28 weeks of gestational age, with BPD, followed or not at CHIC Receives: Device: OCT Angiography |
| 28 childrens in the control group | Other | 28 childrens in the control group (no prematurity, no BPD), selected during a routine ophthalmology consultation scheduled at CHIC, born at ≥38 weeks of gestational age Receives: Device: OCT Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Highlight a difference in vascular density on OCT-A (%), between preterm infants (born ≤ 28 weeks of gestational age) and control infants (born > 38 weeks of gestational age)
Macular and peripapillary vascular densities "percent" based on OCT-A images of the superficial and deep capillary plexuses in the control group of children and the preterm infant group
Measured: Day 1
Secondary outcomes (5)
Evaluation of retinal vascular density using OCT-A in preterm and term-born children
percent of retinal vascular density measured on OCT-A images in preterm and term-born children.
Measured: Day 1
Foveal avascular zone area
Area of the foveal avascular zone measured on OCT-A images, expressed in mm².
Measured: Day 1
Fractal dimension on OCT-A images
Fractal dimension calculated from OCT-A retinal vascular images.
Measured: Day1
Best-corrected visual acuity
Best-corrected visual acuity assessed using the Snellen scale.
Measured: Day1
Visual acuity (Snellen scale) with correction Spherical equivalent (SE)
Spherical equivalent calculated as: SE = S + ½ C
Measured: Day1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study startJun 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchopulmonary DysplasiaStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study population is divided into three groups of children: * 14 former preterm children born at ≤28 weeks of gestational age, without bronchopulmonary dysplasia (BPD), followed or not at CHIC * 14 preterm children born at ≤28 weeks of gestational age, with BPD, followed or not at CHIC * 28 patients in the control group (no prematurity, no BPD), selected during a routine ophthalmology consultation scheduled at CHIC, born at ≥38 weeks of gestational age
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samia SERAY, Dr, Principal investigator, Centre Hospitalier intercommunal de Créteil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07586683
- Sponsor's protocol ID
- OCTA_BRO
- Acronym
- OCTA_BRO
- Status last verified
- Jun 2026
- First submitted
- 17 Apr 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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
- OCTA Evaluation of Retinal Vascularization in Preterm Infants With or Without Bronchopulmonary Dysplasia
- ClinicalTrials.gov ID
- NCT07586683
- Acronym / sponsor ID
- OCTA_BRO / OCTA_BRO
- Conditions
- Bronchopulmonary Dysplasia
- Keywords
- OCT_A, children born prematurely, Bronchopulmonary dysplasia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 14 May 2026 (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 weeks of amenorrhea, in a centrifugal pattern starting from the optic disc. In the case of premature birth, the immature peripheral retina is at risk of ischemia due to incomplete vascular development.
Prematurity is often associated with respiratory fragility. It frequently requires ventilatory support in the form of oxygen therapy, either invasive (orotracheal intubation) or non-invasive, which induces reflex arteriolar vasoconstriction, thereby worsening the existing ischemia. This raises the question of whether subclinical retinal vascular changes, detectable by OCT angiography, may explain the increased risk of amblyopia and the need for optical correction observed in these patients.
OCT angiography is rapidly expanding in the field of retinal vascular diseases: it is a simple, fast, reliable, and non-invasive examination, requiring no injection, that enables high-resolution visualization of retinal vascularization, with separate analysis of the retinal plexuses and the choriocapillaris.
Detailed description
Retinal vascularization in humans develops between the 16th and 36th weeks of gestational age, progressing centrifugally from the optic disc. In the case of premature birth, the immature peripheral retina is at risk of ischemia due to incomplete vascular development. This lack of perfusion in the retinal periphery leads to abnormal secretion of pro-angiogenic factors, promoting the formation of abnormal neovessels, which may be complicated by vitreous hemorrhage and tractional retinal detachment, resulting in permanent visual impairment.
Conversely, it is known that premature infants have a smaller central avascular zone compared with full-term infants. This region of the retina, where 90% of cones are concentrated, must remain free of vascular structures to allow optimal vision.
Prematurity is often associated with respiratory fragility. It frequently requires ventilatory support in the form of oxygen therapy, either invasive (orotracheal intubation) or non-invasive, which induces reflex arteriolar vasoconstriction and worsens the ischemia already present in the periphery.
Clinically, after birth, ocular disorders are more frequently observed in premature children, including amblyopia, impaired contrast sensitivity, refractive errors, strabismus, and optic nerve abnormalities.
It is therefore reasonable to question whether subclinical retinal vascular changes exist, detectable by OCT angiography, and associated with these clinical differences.
Indeed, OCT-A makes it possible to detect changes in foveal and peripapillary retinal microvascularization more sensitively than dilated fundus examination (allowing detection of subclinical microvascular abnormalities), as has been demonstrated in numerous retinal diseases. It thus contributes to diagnosis, follow-up, assessment of therapeutic response, and prognosis in many retinal pathologies.
OCT angiography is rapidly expanding in the field of retinal vascular diseases: it is a simple, quick, reliable, non-invasive, dye-free examination that enables high-resolution study of retinal vasculature, with separate analysis of the retinal plexuses and the choriocapillaris.
It would also be of interest to investigate whether there is a correlation between neonatal parameters, retinal vascular changes observed on OCT-A, and clinical findings (vision and refraction). If such a correlation is demonstrated, it could enable targeted and personalized visual screening of individuals identified as being at highest risk, with stratification of ocular risk based on neonatal history and OCT-A measurements.
Finally, such a study would improve our understanding of retinal development during the neonatal period, the factors that may influence it, and the mechanisms potentially responsible for the observed disorders.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study population is divided into three groups of children: * 14 former preterm children born at ≤28 weeks of gestational age, without bronchopulmonary dysplasia (BPD), followed or not at CHIC * 14 preterm children born at ≤28 weeks of gestational age, with BPD, followed or not at CHIC * 28 patients in the control group (no prematurity, no BPD), selected during a routine ophthalmology consultation scheduled at CHIC, born at ≥38 weeks of gestational age
| Arm | Type | Receives |
|---|---|---|
| former preterm children born | Other | Device: OCT Angiography14 former preterm children born at ≤28 weeks of gestational age, without bronchopulmonary dysplasia (BPD), followed or not at CHIC 14 preterm children born at ≤28 weeks of gestational age, with BPD, followed or not at CHIC |
| 28 childrens in the control group | Other | Device: OCT Angiography28 childrens in the control group (no prematurity, no BPD), selected during a routine ophthalmology consultation scheduled at CHIC, born at ≥38 weeks of gestational age |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Preterm group:
- Any child aged 5 to 15 years born at or before 28 weeks' gestation (with or without bronchopulmonary dysplasia), followed or not at CHIC.
- -Control group: Any child aged 5 to 15 years born at or after 38 weeks' gestation, attending ophthalmology consultations at CHIC.
- Agreement to participate in the study protocol
- Child living near CHI Créteil
Key exclusion criteria (8 listed)
- Neurobehavioral disorders or psychomotor delay preventing the examination from being performed
- Presence of ROP (retinopathy of prematurity) involving zone I or having received intravitreal injections (IVT) of anti-VEGF (as this may directly alter OCT-A parameters)
- Pre-existing retinal disease: macular scar of any cause, retinal vascular abnormalities such as sickle cell disease or diabetes
- Pre-existing optic nerve diseases: glaucoma, coloboma, tumors
- Chronic respiratory diseases other than BPD (bronchopulmonary dysplasia) (i.e., not associated with prematurity): cystic fibrosis, bronchiectasis, etc.
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 AngiographyOCTA evaluation of retinal vascularization in preterm infants with or without bronchopulmonary dysplasia. | Device | 28 childrens in the control group, former preterm children born |
Primary outcome
Highlight a difference in vascular density on OCT-A (%), between preterm infants (born ≤ 28 weeks of gestational age) and control infants (born > 38 weeks of gestational age)
Time frame: Day 1
Macular and peripapillary vascular densities "percent" based on OCT-A images of the superficial and deep capillary plexuses in the control group of children and the preterm infant group
5 secondary outcomes
Evaluation of retinal vascular density using OCT-A in preterm and term-born children
Time frame: Day 1
Foveal avascular zone area
Time frame: Day 1
Fractal dimension on OCT-A images
Time frame: Day1
Best-corrected visual acuity
Time frame: Day1
Visual acuity (Snellen scale) with correction Spherical equivalent (SE)
Time frame: Day1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
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Ventilator Pressure and Optimization of Compliance and Hemodynamics
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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.
Samia SERAY, Dr principal investigator
Centre Hospitalier intercommunal de Créteil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OCT Angiography in people with Bronchopulmonary Dysplasia, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
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 6 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: opening soon, 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.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samia SERAY, Dr (01 57 02 20 00/8122, samia.seray@chicreteil.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Highlight a difference in vascular density on OCT-A (%), between preterm infants (born ≤ 28 weeks of gestational age) and control infants (born > 38 weeks of gestational age) (time frame: Day 1). 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; AzTrials last refreshed its copy on 6 Nov 2026.