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Completed NCT04067973

Impact of Prematurity on the Optic Nerve

Conditions: Ocular Surface Disease, Premature

Sex: All
Ages: 5 Years – 10 Years
Healthy volunteers: No
Enrollment: 88
Sponsor: Nantes University Hospital

Location: CHU de Nantes Nantes

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.

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04067973). StuddyBuddy aggregates publicly available trial information.