Impact of Prematurity on the Optic Nerve

NCT04067973 | Completed

• 1 other identifier: RC19_0026
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Ocular Surface Disease; Premature

Keywords

optic nerve; premature

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Compare the cup/disc ratio

  20 seconds

• eye length

  10 seconds

• Intraocular tension

  20 seconds

• Pachymetry

  20 seconds

• refractive measurements

  20 seconds

Study Arms (2)

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.

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

CHU de Nantes

Nantes, 44093, France

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: August 28, 2019
• Study Start: September 9, 2019
• Primary Completion: December 10, 2019
• Study Completion: December 10, 2019
• Last Updated: June 23, 2026

Record last verified: 2026-06

Locations

FR (1)