Incidence of Myopia in a Prospective Cohort of Emmetropic Children and Associated Ocular and Environmental Factors

NCT07316998 | Not Yet Recruiting

• 1 other identifier: TCN_2025_8
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Myopia and high myopia are among the leading causes of visual impairment and blindness worldwide. The total number of people with myopia worldwide was estimated at 2.6 billion in 2020 and could reach 4.8 billion by 2050 unless preventive interventions are implemented. Most epidemiological studies have focused on risk factors for myopia progression, with far fewer addressing the factors that cause a child to shift from emmetropia to myopia. The risk factors for the onset of myopia may be the same as those for myopia progression. However, for an equivalent level of risk exposure, it remains unclear why some children develop myopia while others do not. Identifying the population most at risk of developing myopia would make it possible to propose preventive treatments aimed at delaying or preventing its onset. This would allow evaluation of the effectiveness of current myopia control treatments (peripheral defocus lenses, atropine, contact lenses) in preventing the onset of myopia, as well as future targeted treatments, including the potential benefit of early optical correction-a strategy once used but later abandoned due to a lack of robust scientific evidence. The establishment of longitudinal follow-up of young emmetropic children at the French Institute of Myopia will enable the acquisition of high-quality imaging, allowing investigation of the association between advanced imaging parameters and external environmental factors with the onset of myopia.

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• To describe the incidence of myopia over the 2 years following inclusion in emmetropic children.

  Onset of myopia within the 2 years following inclusion, defined as a spherical equivalent (SE) ≤ -0.50 D in at least one eye. Measurement of the spherical equivalent will be performed under cycloplegia using an autorefractor.

  Annual follow up : Year 1 and year 2

Secondary Outcomes (1)

• To describe the incidence of myopia over the 5 years following inclusion in emmetropic children.

  annual follow-up until Year 5

Study Arms (1)

Children aged 4 to 8 years at inclusion, emmetropic (cycloplegic SE 0 to +2D) in each eye d

Other: annual follow-up

Interventions

annual follow-up OTHER

annual follow-up including ophtalmologic examination and biometry and behavioural questionnaires

Children aged 4 to 8 years at inclusion, emmetropic (cycloplegic SE 0 to +2D) in each eye d

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children aged 4 to 8 years at inclusion, emmetropic (cycloplegic refractive error between 0 and +2 diopters - inclusive - in spherical equivalent in each eye).

You may qualify if:

• Age ≥ 4 years and \< 9 years
• Spherical equivalent measured by autorefractometer ≥ 0.00 and ≤ +2.00 diopters in each eye (cycloplegic autorefraction)

You may not qualify if:

• Presence of trauma in at least one eye
• Presence of inflammatory ocular pathology in at least one eye
• History of intraocular pressure-lowering ophthalmic treatment, intravitreal injections, laser treatment, or myopia control therapy (e.g., atropine, orthokeratology, myopia control lenses)
• History of ophthalmic surgery other than for the management of strabismus (e.g., cataract surgery, filtering surgery, intravitreal surgery) in at least one eye

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

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: December 19, 2025
• First Posted: January 5, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2031
• Study Completion (Estimated): February 1, 2031
• Last Updated: January 5, 2026

Record last verified: 2025-12