NCT06895044 Evolution of Ocular Growth in Myopic Children: A Prospective Cohort Study
| NCT ID | NCT06895044 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondation Ophtalmologique Adolphe de Rothschild |
| Condition | Myopia |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2025-04-30 |
| Primary Completion | 2033-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2025-04-30 with a primary completion date of 2033-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Myopia and high myopia are the leading causes of visual impairment and blindness worldwide. The total number of myopic people globally was estimated to be 2.6 billion in 2020, and it could reach 4.8 billion by 2050 unless preventive interventions are implemented. Strategies to slow the progression of myopia, such as contact lenses, orthokeratology, atropine, and increased time spent outdoors, have shown promising results, although evidence varies depending on the method. However, most research has been conducted in Asia, and there are few studies on ocular growth in myopic children in Europe. Meanwhile, the prevalence of myopia is also increasing significantly in Europe, particularly in France. Understanding the growth of the myopic eye in European children is crucial. Cohort studies of myopic children are scarce and do not always include high-quality imaging. A cohort of myopic children with prospective collection of the best retinal and corneal images, along with ophthalmological exams to detail and model the growth of the myopic eye, will provide valuable insights to enhance our understanding of ocular growth and its inter-individual variability.
Eligibility Criteria
Inclusion Criteria: * Myopia in at least one eye, defined as a refractive error in spherical equivalent ≤ -0.50 diopters (autorefraction under cycloplegia) * Affiliated or beneficiary of a social security system * Explicit consent from a holder of parental authority Exclusion Criteria: * Presence of trauma in both eyes * Presence of inflammatory conditions in both eyes * History of intraocular surgery (cataract, filtering surgery, intra-vitreal surgery) in both eyes * Patient benefiting from legal protection measures
Contact & Investigator
Thibaut Chapron, Dr
PRINCIPAL INVESTIGATOR
Hôpital Fondation Adolphe de Rothschild
Frequently Asked Questions
Who can join the NCT06895044 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 17 Years, studying Myopia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06895044 currently recruiting?
Yes, NCT06895044 is actively recruiting participants. Contact the research team at ayavchitz@for.paris for enrollment information.
Where is the NCT06895044 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT06895044 clinical trial?
NCT06895044 is sponsored by Fondation Ophtalmologique Adolphe de Rothschild. The principal investigator is Thibaut Chapron, Dr at Hôpital Fondation Adolphe de Rothschild. The trial plans to enroll 1,000 participants.