Clinical trial NCT04067973: Impact of Prematurity on the Optic Nerve
Official title: Impact of Prematurity on the Morphological and Tomographic Aspect of the Papilla
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ocular Surface Disease
Premature
Keywords: optic nerve
premature
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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
* 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)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Compare the thickness of the optical fibres measured in OCT RNFL between premature subjects and controls.
timeFrame: 10 minutes
Secondary outcomes:
measure: Compare the cup/disc ratio
timeFrame: 20 seconds
measure: eye length
timeFrame: 10 seconds
measure: Intraocular tension
timeFrame: 20 seconds
measure: Pachymetry
timeFrame: 20 seconds
measure: refractive measurements
timeFrame: 20 seconds
Other outcomes:
Locations:
Study officials:
References: