Ocular Surface DiseaseNCT04067973
Impact of Prematurity on the Optic Nerve
An observational study of Ocular Surface Disease and Premature, run by Nantes University Hospital at 1 site in France.
Trial summary
The purpose of this protocol is to study the consequences of prematurity on the optic nerve. Indeed, the work already carried out on the subject suggests that prematurity induces suffering of the optic nerve with a loss of optical fibre, an essential element in the transmission of the visual nerve signal to the brain. Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Ocular Surface Disease, Premature
- How many people
- 88 participants
- Where
- 1 siteFrance
- Study dates
- 9 Sep 2019to 10 Dec 2019
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 10 years
- All sexes
- No healthy volunteers
- Child
Study population: Prospective monocentric case-control study, based on the use of data recovered after a single patient visit. Conduct of a visit for the patient (case control): * Reception of the patient and his parents or legal representatives * Information to the patient and his parents or legal representatives of the study * Carrying out the standard consultation (optical correction most often) then carrying out additional examinations necessary for the study. * This visit is unique, there will be no further visits.
Who may be able to join
- For patients:
- between 5 and 10 years old
- Premature births: before 37 weeks of amenorrhea
- To be able to benefit from the examinations necessary for the study (being able to set a target, to install correctly on the machines)
- For control:
- Aged between 5 and 10 years old
Show all 9Show fewer
- Born after 37 SA
- No known ophthalmological pathologies
- To be able to benefit from the examinations necessary for the study (being able to set a target, to install correctly on the machines)
Who cannot join
- Patients who cannot benefit from the examinations (patients in wheelchairs, whose psychomotor delay prevents a good understanding of the examination and the need to set a target)
- patient under the protection of justice.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Prematurity on the Morphological and Tomographic Aspect of the Papilla
The purpose of this protocol is to study the consequences of prematurity on the optic nerve. Indeed, the work already carried out on the subject suggests that prematurity induces suffering of the optic nerve with a loss of optical fibre, an essential element in the transmission of the visual nerve signal to the brain.
The investigators will therefore study two populations: a population of premature infants aged 5 to 10 years, and a control population of term infants.
Read more
The examinations performed are painless, non-invasive and non-irradiating. To date, there are no known adverse reactions to these tests. These examinations are a photo of the fundus (retinophotography), a pachymetry (measurement of the thickness of the non-contact cornea), an OCT RNFL (optical coherence tomography, scanner of the non-irradiating non-painful optical nerve) and the taking of the IOP (intraocular pressure).
They aim to measure the main morphological characteristics of the eye and the optic nerve.
This is a prospective observational study. The inclusion and measurements necessary for the study are made on the day of the consultation.
The expected results will provide new data on this population of premature infants, allowing for better management if a pathology involving the optic nerve were to occur at any age in these patients.
Read the detailed description
The prematurity of the newborn is now a major theme in medical research. Indeed, technological progress makes it possible to revive increasingly premature children. But being born premature also brings many complications, some of which are already well known (pulmonary, cardiac, digestive complications, etc....). At the ophthalmological level, the retinopathy of the premature child is an entity already well described, this retinal vascularization anomaly leads to many complications on the child's visual future. The optic nerves of premature infants are described as larger than those of normal children.
Recently, a new ophthalmological condition has been described. This is the damage to the optic nerve of the premature baby, characterized by a loss of optical fibres, of major importance in the transmission of the visual signal to the brain.
The aim of this study is to characterize the particularities of the optic nerve of the premature child, as there is currently very little data available on it in this context. Some studies have reported this, but with results that are not always homogeneous. For example, some studies report a lack of optic fiber in the temporal area of the optic nerve, while others find more pronounced atrophy on the nasal side, which has practical consequences in the examination and monitoring of these children.
A better understanding of these disorders would make it possible to establish monitoring protocols for these children born with nerve fibre deficiency, especially to prevent subsequent fibre loss due to any pathology of ocular tone, the best known of which is glaucoma.
The purpose of this prospective study is to compare the aspects of optic nerves in premature infants compared to those of optic nerves in non-premature infants. This aspect changes with age, with a progressive physiological decrease in the thickness of optic fiber within the optic nerve over time. It is therefore essential to match the two age groups to exploit this data.
- Conditions
- Ocular Surface Disease, Premature
- Keywords
- optic nerve, premature
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients | Premature subjects benefit from the examinations described in the protocol, namely automated refractometry, intraocular air pressure, biometrics (with axial length and pachymetry (corneal thickness) performed by the same machine at the same time), a photo of the fundus (retinophotography) and an OCT RNFL. These examinations are necessary for the follow-up of premature children. All children examined at Nantes University Hospital benefit systematically from: automated refractometry, intraocular pressure in the air and a photo of the fundus. | |
| control | controls benefit from two additional tests: RNFL OCT and biometrics. The duration of the RNFL OCT is about 2 minutes, with a total of 10 seconds per eye, the rest being computer manipulation. The biometrics take about 2 minutes to complete, with a total of 30 seconds per eye, the rest being computer manipulation. These two reviews are conducted on the same day as the initial consultation and directly following the consultation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the thickness of the optical fibres measured in OCT RNFL between premature subjects and controls.
The examinations performed are painless, non-invasive and non-irradiating. To date, there are no known adverse reactions to these tests. These examinations are a photo of the fundus (retinophotography), a pachymetry (measurement of the thickness of the non-contact cornea), an OCT RNFL (optical coherence tomography, scanner of the non-irradiating non-painful optical nerve) and the taking of the IOP (intraocular pressure).
They aim to measure the main morphological characteristics of the eye and the optic nerve.
We will therefore study two populations: a population of premature infants aged 5 to 10 years, and a control population of term infants.
Measured: 10 minutes
Secondary outcomes (5)
Compare the cup/disc ratio
Compare the cup/disc ratio (optic nerve excavation, a criterion well used in the study of glaucoma) between the premature population and the control population.
Measured: 20 seconds
eye length
compare the measurement of the axial eye length (eye length) between the two populations.
Measured: 10 seconds
Intraocular tension
compare the intraocular tension (which can lead to a loss of optical fibre if too high, a criterion measured to avoid any bias induced by hypertonia on the thickness of the optical fibres) between the two populations.
Measured: 20 seconds
Pachymetry
compare pachymetry (corneal thickness, measurement that may interfere with intraocular pressure measurement) between premature born patients and controls
Measured: 20 seconds
refractive measurements
compare refractive measurements (myopia, hyperopia, astigmatism) between the two populations
Measured: 20 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start9 Sep 2019
- Primary completion10 Dec 2019
- Study completion10 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular Surface DiseaseStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04067973
- Sponsor's protocol ID
- RC19_0026
- Status last verified
- Jun 2026
- First submitted
- 22 Aug 2019
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Prematurity on the Morphological and Tomographic Aspect of the Papilla
- ClinicalTrials.gov ID
- NCT04067973
- Acronym / sponsor ID
- RC19_0026
- Conditions
- Ocular Surface Disease, Premature
- Keywords
- optic nerve, premature
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 10 Dec 2019 (actual)
- Study completion
- 10 Dec 2019 (actual)
- First posted
- 28 Aug 2019 (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.
The purpose of this protocol is to study the consequences of prematurity on the optic nerve. Indeed, the work already carried out on the subject suggests that prematurity induces suffering of the optic nerve with a loss of optical fibre, an essential element in the transmission of the visual nerve signal to the brain.
The investigators will therefore study two populations: a population of premature infants aged 5 to 10 years, and a control population of term infants.
The examinations performed are painless, non-invasive and non-irradiating. To date, there are no known adverse reactions to these tests. These examinations are a photo of the fundus (retinophotography), a pachymetry (measurement of the thickness of the non-contact cornea), an OCT RNFL (optical coherence tomography, scanner of the non-irradiating non-painful optical nerve) and the taking of the IOP (intraocular pressure).
They aim to measure the main morphological characteristics of the eye and the optic nerve.
This is a prospective observational study. The inclusion and measurements necessary for the study are made on the day of the consultation.
The expected results will provide new data on this population of premature infants, allowing for better management if a pathology involving the optic nerve were to occur at any age in these patients.
Detailed description
The prematurity of the newborn is now a major theme in medical research. Indeed, technological progress makes it possible to revive increasingly premature children. But being born premature also brings many complications, some of which are already well known (pulmonary, cardiac, digestive complications, etc....). At the ophthalmological level, the retinopathy of the premature child is an entity already well described, this retinal vascularization anomaly leads to many complications on the child's visual future. The optic nerves of premature infants are described as larger than those of normal children.
Recently, a new ophthalmological condition has been described. This is the damage to the optic nerve of the premature baby, characterized by a loss of optical fibres, of major importance in the transmission of the visual signal to the brain.
The aim of this study is to characterize the particularities of the optic nerve of the premature child, as there is currently very little data available on it in this context. Some studies have reported this, but with results that are not always homogeneous. For example, some studies report a lack of optic fiber in the temporal area of the optic nerve, while others find more pronounced atrophy on the nasal side, which has practical consequences in the examination and monitoring of these children.
A better understanding of these disorders would make it possible to establish monitoring protocols for these children born with nerve fibre deficiency, especially to prevent subsequent fibre loss due to any pathology of ocular tone, the best known of which is glaucoma.
The purpose of this prospective study is to compare the aspects of optic nerves in premature infants compared to those of optic nerves in non-premature infants. This aspect changes with age, with a progressive physiological decrease in the thickness of optic fiber within the optic nerve over time. It is therefore essential to match the two age groups to exploit this data.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients | – | –Premature subjects benefit from the examinations described in the protocol, namely automated refractometry, intraocular air pressure, biometrics (with axial length and pachymetry (corneal thickness) performed by the same machine at the same time), a photo of the fundus (retinophotography) and an OCT RNFL. These examinations are necessary for the follow-up of premature children. All children examined at Nantes University Hospital benefit systematically from: automated refractometry, intraocular pressure in the air and a photo of the fundus. |
| control | – | –controls benefit from two additional tests: RNFL OCT and biometrics. The duration of the RNFL OCT is about 2 minutes, with a total of 10 seconds per eye, the rest being computer manipulation. The biometrics take about 2 minutes to complete, with a total of 30 seconds per eye, the rest being computer manipulation. These two reviews are conducted on the same day as the initial consultation and directly following the consultation. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Prospective monocentric case-control study, based on the use of data recovered after a single patient visit. Conduct of a visit for the patient (case control): * Reception of the patient and his parents or legal representatives * Information to the patient and his parents or legal representatives of the study * Carrying out the standard consultation (optical correction most often) then carrying out additional examinations necessary for the study. * This visit is unique, there will be no further visits.
Key inclusion criteria (9 listed)
- For patients:
- between 5 and 10 years old
- Premature births: before 37 weeks of amenorrhea
- To be able to benefit from the examinations necessary for the study (being able to set a target, to install correctly on the machines)
- Aged between 5 and 10 years old
Key exclusion criteria (2 listed)
- Patients who cannot benefit from the examinations (patients in wheelchairs, whose psychomotor delay prevents a good understanding of the examination and the need to set a target)
- patient under the protection of justice.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Compare the thickness of the optical fibres measured in OCT RNFL between premature subjects and controls.
Time frame: 10 minutes
The examinations performed are painless, non-invasive and non-irradiating. To date, there are no known adverse reactions to these tests. These examinations are a photo of the fundus (retinophotography), a pachymetry (measurement of the thickness of the non-contact cornea), an OCT RNFL (optical coherence tomography, scanner of the non-irradiating non-painful optical nerve) and the taking of the IOP (intraocular pressure). They aim to measure the main morphological characteristics of the eye and the optic nerve. We will therefore study two populations: a population of premature infants aged 5 to 10 years, and a control population of term infants.
5 secondary outcomes
Compare the cup/disc ratio
Time frame: 20 seconds
eye length
Time frame: 10 seconds
Intraocular tension
Time frame: 20 seconds
Pachymetry
Time frame: 20 seconds
refractive measurements
Time frame: 20 seconds
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ocular Surface Disease and Premature, run by Nantes University Hospital 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 9 inclusion and 2 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: finished, as of the sponsor's last update on 23 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Compare the thickness of the optical fibres measured in OCT RNFL between premature subjects and controls. (time frame: 10 minutes). 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 23 Jun 2026.