MyopiaPREMYOM1000NCT06895044
Evolution of Ocular Growth in Myopic Children: A Prospective Cohort Study
An observational study of Myopia, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Myopia
- What is being tested?
- ophtalmologic follow-up and ophtalmological follow-up
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 30 Apr 2025to 30 Apr 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients aged 6 to 17 years at inclusion, diagnosed with myopia (refractive error of -0.5 D or less in spherical equivalent in at least one eye)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Fondation A. de Rothschild
Paris, 75019
Thibaut Chapron, Dr, (0)148036437 ext. +33, tchapron@for.paris
Thibaut Chapron, Dr
About this 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.
- Conditions
- Myopia
- Being tested
- ophtalmologic follow-up, ophtalmological follow-up
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ophtalmologic follow-upOther
alls exams included in ophtalmologic follow-up every 6 months for 5 years
ophtalmological follow-upOther
all exams included in ophtalmological follow-up including axial length mesurment every 6 moths
What is being measured
The primary outcome is the main question the study is designed to answer.
axial length
Measurement of axial length by IOL Master
Measured: Year 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start30 Apr 2025
- Primary completion30 Apr 2033 (estimated)
- Study completion30 Apr 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Thibaut Chapron, Dr, Principal investigator, Hôpital Fondation Adolphe de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06895044
- Sponsor's protocol ID
- SBN_2024_13
- Acronym
- PREMYOM1000
- Status last verified
- Dec 2025
- First submitted
- 19 Mar 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Ocular Growth in Myopic Children: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06895044
- Acronym / sponsor ID
- PREMYOM1000 / SBN_2024_13
- Conditions
- Myopia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 30 Apr 2033 (estimated)
- Study completion
- 30 Apr 2033 (estimated)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients aged 6 to 17 years at inclusion, diagnosed with myopia (refractive error of -0.5 D or less in spherical equivalent in at least one eye)
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ophtalmologic follow-upalls exams included in ophtalmologic follow-up every 6 months for 5 years | Other | – |
| ophtalmological follow-upall exams included in ophtalmological follow-up including axial length mesurment every 6 moths | Other | – |
Primary outcome
axial length
Time frame: Year 5
Measurement of axial length by IOL Master
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thibaut Chapron, Dr principal investigator
Hôpital Fondation Adolphe de Rothschild
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amelie Yavchitz (+33148036454, ayavchitz@for.paris), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
axial length (time frame: Year 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.