Impact of Prematurity on the Optic Nerve

Premature Clinical Trial

Official title:

Impact of Prematurity on the Morphological and Tomographic Aspect of the Papilla

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04067973
• Other study ID #: RC19_0026
• Status: Not yet recruiting
• Start date: September 2, 2019
• Est. completion date: September 2, 2020

Study information

• Verified date: August 2019
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 2, 2020
• Est. primary completion date: March 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ocular Surface Disease
• Premature
• Premature Birth

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 minutes
Secondary	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.	20 seconds
Secondary	eye length	compare the measurement of the axial eye length (eye length) between the two populations.	10 seconds
Secondary	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.	20 seconds
Secondary	Pachymetry	compare pachymetry (corneal thickness, measurement that may interfere with intraocular pressure measurement) between premature born patients and controls	20 seconds
Secondary	refractive measurements	compare refractive measurements (myopia, hyperopia, astigmatism) between the two populations	20 seconds