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Premature birth may leave lasting marks on the optic nerve

NCT ID NCT04067973

Knowledge-focused Sponsor: Nantes University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether being born too early changes the structure of the optic nerve, which sends visual signals from the eye to the brain. Researchers will compare eye scans from children aged 5 to 10 who were born prematurely with those born full-term. The tests are painless and non-invasive, and the goal is to understand if prematurity causes lasting differences that could affect future eye health.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If differences are found, it could help doctors better monitor and manage eye health in people born prematurely.
What could go wrong
This is an observational study, not a treatment trial. It may find no significant differences, and results may not apply to all premature infants.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

88 people

The number who actually took part.

Started

Sep 2019

Finished

Dec 2019

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

5 to 10 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

Premature Birth

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ocular surface disease Premature

Contacts and locations

Locations

  • CHU de Nantes

    Nantes, 44093, France

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