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

Recruiting

• Conditions: Myopia

• Registration Number: NCT06895044
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-19
• Study First Submitted QC: 2025-03-19
• Study First Posted: 2025-03-26
• Study Start: 2025-04-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-09
• Last Update Posted: 2025-05-11
• Primary Completion: 2033-04-30
• Study Completion: 2033-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
axial length	Year 5	Measurement of axial length by IOL Master

Trial Locations

Locations (1)

Hôpital Fondation A. de Rothschild; 🇫🇷 Paris, France