ClinicalTrials.gg
RecruitingNCT07316998PREMYOPUpdated Jul 23, 2026

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

An observational study in Myopia, sponsored by Fondation Ophtalmologique Adolphe de Rothschild. Recruiting at 1 site in France. Open to participants aged 4 Years to 8 Years. Per ClinicalTrials.gov, last updated 2026-07-23.

Sponsored by Fondation Ophtalmologique Adolphe de Rothschild · Observational

From the registry’s dates

  • Started Feb 2026; still recruiting 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
4 Years to 8 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 29 studies in Myopia with a site in France — 12 open to participants now, 13 under way, none of them phase 3. Myopia · France.

Started
2026
with 7 others
Observational
9 of 29
4 open now
Primary completion
2031-02
later than 11 of 12 live
Registered
23rd of 29
by date
Lead sponsor
6 of 29
Fondation Ophtalmologique Adolphe de Rothschild

Among the 29 studies in Myopia with a site in France, this one is one of 8 that started in 2026, is one of 9 observational ones, reaches primary completion later than 11 of the 12 other live ones, and was the 23rd registered.

Myopia

1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.

Browse Myopia studies →

Open to participants now

12 of the 29 studies in Myopia with a site in France are open now. Recruiting first, the newest first:

6 more — sign in →

All 12 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 122 Myopia studies recruiting now, 19 (16%) set no upper age limit and 102 (84%) stop at 75 or younger; 86 take children under 18; 53 take healthy volunteers.

This study: 4 Years to 8 Years · all sexes · no healthy volunteers.

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02

Study 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.

03

Conditions studied

  • Myopia

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04

Who can participate

Ages eligible
4 Years to 8 Years
Sexes eligible
All
Accepts healthy volunteers
No
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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

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

    Other: annual follow-up

Interventions

  • Otherannual follow-up

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

06

What researchers measure

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.

    Time frame: 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.

    Onset of myopia within the 5 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.

    Time frame: annual follow-up until Year 5

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2026 (actual). Primary completion is estimated for Feb 2031, 60 months after the start.

Of 87 non-industry observational studies under Myopia, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 90. This study's planned 60 months is above that.

Counting every sponsor, half of 96 studies reached it within 24 months; a quarter within 10 and three quarters within 59.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 19, 2025
First posted
Jan 5, 2026
StartActual
Feb 18, 2026
Primary completionEst.
Feb 2031
CompletionEst.
Feb 2031
Last update
Jul 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07316998
Responsible party
Sponsor
First posted
Jan 5, 2026
Start date
Feb 18, 2026
Primary completion
Feb 2031 (estimated)
Completion
Feb 2031 (estimated)
Last update
Jul 23, 2026

Study contacts

Yavchitz
Contact
ayavchitz@for.paris
+33148036454

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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