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Recruiting NCT06895044

Evolution of Ocular Growth in Myopic Children: A Prospective Cohort Study

Observational Myopia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ophtalmologic follow-up, ophtalmological follow-up.
Who it may be relevant to
Registry conditions: Myopia. Basic parameters: 6 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other ophtalmologic follow-up
    alls exams included in ophtalmologic follow-up every 6 months for 5 years
  • Other ophtalmological follow-up
    all exams included in ophtalmological follow-up including axial length mesurment every 6 moths

Primary outcome measures

  • axial length [Time frame: Year 5]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Hôpital Fondation A. de Rothschild — Paris

Identifiers

NCT: NCT06895044 · SBN_2024_13

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗