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800 kids with rare eye conditions to be tracked for 10 years

NCT ID NCT05954403

Knowledge-focused Sponsor: Institut National de la Santé Et de la Recherche Médicale, France Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 08, 2026 · Updated 2 times

Summary

This study follows 800 children born with eye malformations like microphthalmia, anophthalmia, aniridia, or anterior segment defects. Researchers will track their vision, brain development, and overall health for up to 10 years to better predict outcomes. No new treatments are being tested; the goal is to learn how these conditions progress and improve patient care.

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

About 800 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2017

Expected to finish

Jul 2037

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Who is studied

Patients from 0 to 7 years old We aim to include most patients born with a developmental ocular defect. Even if most ocular defects are diagnosed during the first months of age, patients could be included in the cohort until 7 years old. Patients over 8 years old: Affected adults and children over 8 years old will not be included in the follow-up subgroup.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Newborns and/or children from birth to 7 years old, Children from 8 years old affected with the following ocular defects: anophthalmia, microphthalmia, aniridia or anterior segment dysgnesis.whose parents will have properly evaluated risks and benefits of the study and will be given an informed consent to participate the protocol. * Patients affiliated to the "Régime National d'Assurance Maladie". Inclusion of foreign patients will be possible through the French inclusion centers when they agreed to be charged for all medical fees. * Adults affected with the following ocular defects: anophthalmia, microphthalmia, aniridia or anterior segment dysgenesis * Adult patients under guardianship whose guardians will have properly evaluated risks and benefits of the study and will be given an informed consent to participate the protocol. Indeed, intellectual disability may be associated with the ocular defects and we will need to include these patients in order to evaluate incidence of this event. * Adult patients able to properly evaluate risks and benefits of the study and to give their informed consent to participate to the protocol. * Adult parents of an affected child participating to the study and willing to participate to the inheritance study (results of DNA analysis). * Inclusion of foreign patients will be possible through the French inclusion centres when they agreed to be charged for all medical fees. Pregnant women can be included in the study Exclusion Criteria: * No exclusion criteria

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Conditions

The condition(s) this trial relates to.

aniridia anophthalmia/microphthalmia-esophageal atresia syndrome Anophthalmos anterior segment dysgenesis anterior segment dysgenesis 3 anterior segment dysgenesis 6 Anterior segment mesenchymal dysgenesis Axenfeld-Rieger syndrome Axenfeld-Rieger syndrome type 3 iris hypoplasia with glaucoma isolated anophthalmia-microphthalmia syndrome microphthalmia Peters anomaly

As listed by the trial registrant

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

Aniridia Anophthalmia Anterior segment dysgenesis 3, rieger subtype Anterior segment dysgenesis 6, peters anomaly subtype Microphthalmia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • RaDiCo-ACOEIL

    RECRUITING

    Paris, Île-de-France Region, 75012, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.