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

NCT ID: NCT06895044

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-30
• Study Completion Date: 2033-04-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

ophtalmologic follow-up

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

Intervention Type: OTHER

ophtalmological follow-up

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thibaut Chapron, Dr

Role: PRINCIPAL_INVESTIGATOR

Hôpital Fondation Adolphe de Rothschild

Locations

Hôpital Fondation A. de Rothschild

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Amelie Yavchitz

Role: CONTACT

ayavchitz@for.paris

+33148036454

Facility Contacts

Thibaut Chapron, Dr

Role: primary

tchapron@for.paris

(0)148036437 ext. +33

Other Identifiers

SBN_2024_13

Identifier Type: -

Identifier Source: org_study_id