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

NCT06895044 | Recruiting

• 1 other identifier: SBN_2024_13
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• axial length

  Measurement of axial length by IOL Master

  Year 5

Interventions

ophtalmologic follow-up OTHER

alls exams included in ophtalmologic follow-up every 6 months for 5 years

ophtalmological follow-up OTHER

all exams included in ophtalmological follow-up including axial length mesurment every 6 moths

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 6 to 17 years at inclusion, diagnosed with myopia (refractive error of -0.5 D or less in spherical equivalent in at least one eye)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Hôpital Fondation A. de Rothschild

Paris, 75019, France

RECRUITING

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Thibaut Chapron, Dr

  Hôpital Fondation Adolphe de Rothschild

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amelie Yavchitz

CONTACT

+33148036454; ayavchitz@for.paris

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 26, 2025
• Study Start: April 30, 2025
• Primary Completion (Estimated): April 30, 2033
• Study Completion (Estimated): April 30, 2033
• Last Updated: December 4, 2025

Record last verified: 2025-12

Locations

FR (1)