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NCT Number: NCT06895044

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

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.

Recruiting

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Key information

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Fondation A. de Rothschild

Paris, 75019, France

Location status: Recruiting

Location contact

Thibaut Chapron, Dr

CONTACT

[email protected]

(0)148036437 ext. +33

Thibaut Chapron, Dr

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. axial length

    Time frame: Year 5

    Measurement of axial length by IOL Master

Study contacts

Contact information is provided by the study sponsor or research team.

Amelie Yavchitz

CONTACT

[email protected]

+33148036454

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Acronym: PREMYOM1000

Important dates

Study start
2025
Primary completion
2033
Study completion
2033
First posted
Mar 26, 2025
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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