MyopiaNCT07120165
Effectiveness of Myopia Control Interventions : A Comparison of Myopia Control in European Children, Adolescents and Young Adults With Defocus Incorporated Multiple Segments (DIMS) and Highly Aspherical Lenslets (HAL) Spectacles, Atropine, Lenses and Combined Treatments
An observational study of Myopia, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
The prevalence of myopia and its complications has risen considerably in recent decades, particularly among children and teenagers. This trend is also spreading in Europe, driven by the increase in screen time and the intensive use of new technologies and social media, particularly among the younger generation. Read more about this study
- Who is it for?
- Ages Up to 25 years
- Conditions the study is for
- Myopia
- What is being tested?
- Demographic data collection, Ophthalmological history and Ophthalmological data at each examination
- How many people
- 114 participants
- Where
- 1 siteFrance
- Study dates
- 20 Oct 2024to 7 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Up to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children or young adults with active myopia treated with ATROPINE 0.01% eye drops or myopia control glasses or contact lenses, and their various combinations will be included.
Who may be able to join
- Children or young adults with active myopia treated with ATROPINE 0.01% eye drops or myopia control glasses or contact lenses, and their various combinations
- patient affiliated with a social security organization
- agreement of both parents or the patient if adult
Who cannot join
- non compliance with treatment
Trial locations and contacts
1 site in 1 country.
About this study
The prevalence of myopia and its complications has risen considerably in recent decades, particularly among children and teenagers. This trend is also spreading in Europe, driven by the increase in screen time and the intensive use of new technologies and social media, particularly among the younger generation.
Several treatment options are available today, including pharmacological treatments with atropine eye drops, as well as optical myopia control systems in the form of glasses or contact lenses.
Read more
These different treatments have been used in clinical practice at Saint-Étienne University Hospital since 2017 for atropine, and more recently with the development of optical myopia control systems and their combinations.
Little clinical data has been published to date on these different treatment combinations in the French population.
The investigators would therefore like to set up a database to publish their results and share their experience.
- Conditions
- Myopia
- Being tested
- Demographic data collection, Ophthalmological history, Ophthalmological data at each examination, Potential adverse events
- Keywords
- Myopia, children, teenagers, atropine, lunettes, contact lenses, combinations
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Demographic data collectionOther
Demographic data collection: age, gender, level of education/study, time spent in near vision, sports practice, medical history
Ophthalmological historyOther
Ophthalmological history: age of myopia discovery, parental refraction, previous refractions, presence of a braking treatment
Ophthalmological data at each examinationOther
Ophthalmological data at each examination: visual acuity, subjective refraction, cycloplegia with SKIACOL, axial length.
Potential adverse eventsOther
Potential adverse events: halos, photophobia, stinging, infections, etc.
| Study group | Role | What they receive |
|---|---|---|
| Atropine 0.01% | Children or young adults with active myopia treated with ATROPINE 0.01% eye drops. Receives: Other: Demographic data collection; Other: Ophthalmological history; Other: Ophthalmological data at each examination; Other: Potential adverse events | |
| DIMS/HAL | Children or young adults with active myopia treated with myopia control glasses. Receives: Other: Demographic data collection; Other: Ophthalmological history; Other: Ophthalmological data at each examination; Other: Potential adverse events | |
| Various combined treatments | Children or young adults with active myopia treated with ATROPINE 0.01% eye drops or myopia control glasses or contact lenses, and their various combinations. Receives: Other: Demographic data collection; Other: Ophthalmological history; Other: Ophthalmological data at each examination; Other: Potential adverse events |
What is being measured
The primary outcome is the main question the study is designed to answer.
Database of active treatments for myopia
Database established with data from children or young adults with active myopia treated with ATROPINE 0.01% eye drops or myopia control spectacles or contact lenses, and their various combinations.
Measured: Month 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start20 Oct 2024
- Primary completion7 May 2025
- Study completion7 May 2025
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 Centre Hospitalier Universitaire de Saint EtienneThe 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
- Retrospective
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Caroline TRONE, Md, Principal investigator, CHU de Saint-Étienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07120165
- Sponsor's protocol ID
- IRBN1022025/CHUSTE
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Myopia Control Interventions : A Comparison of Myopia Control in European Children, Adolescents and Young Adults With Defocus Incorporated Multiple Segments (DIMS) and Highly Aspherical Lenslets (HAL) Spectacles, Atropine, Lenses and Combined Treatments
- ClinicalTrials.gov ID
- NCT07120165
- Acronym / sponsor ID
- IRBN1022025/CHUSTE
- Conditions
- Myopia
- Keywords
- Myopia, children, teenagers, atropine, lunettes, contact lenses, combinations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 20 Oct 2024 (actual)
- Primary completion
- 7 May 2025 (actual)
- Study completion
- 7 May 2025 (actual)
- First posted
- 13 Aug 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.
The prevalence of myopia and its complications has risen considerably in recent decades, particularly among children and teenagers. This trend is also spreading in Europe, driven by the increase in screen time and the intensive use of new technologies and social media, particularly among the younger generation.
Several treatment options are available today, including pharmacological treatments with atropine eye drops, as well as optical myopia control systems in the form of glasses or contact lenses.
These different treatments have been used in clinical practice at Saint-Étienne University Hospital since 2017 for atropine, and more recently with the development of optical myopia control systems and their combinations.
Little clinical data has been published to date on these different treatment combinations in the French population.
The investigators would therefore like to set up a database to publish their results and share their experience.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Atropine 0.01% | – | Other: Demographic data collection, Other: Ophthalmological history, Other: Ophthalmological data at each examination, Other: Potential adverse eventsChildren or young adults with active myopia treated with ATROPINE 0.01% eye drops. |
| DIMS/HAL | – | Other: Demographic data collection, Other: Ophthalmological history, Other: Ophthalmological data at each examination, Other: Potential adverse eventsChildren or young adults with active myopia treated with myopia control glasses. |
| Various combined treatments | – | Other: Demographic data collection, Other: Ophthalmological history, Other: Ophthalmological data at each examination, Other: Potential adverse eventsChildren or young adults with active myopia treated with ATROPINE 0.01% eye drops or myopia control glasses or contact lenses, and their various combinations. |
Who may qualify
- Ages
- Up to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children or young adults with active myopia treated with ATROPINE 0.01% eye drops or myopia control glasses or contact lenses, and their various combinations will be included.
Key inclusion criteria (3 listed)
- Children or young adults with active myopia treated with ATROPINE 0.01% eye drops or myopia control glasses or contact lenses, and their various combinations
- patient affiliated with a social security organization
- agreement of both parents or the patient if adult
Key exclusion criteria (1 listed)
- non compliance with treatment
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 |
|---|---|---|
| Demographic data collectionDemographic data collection: age, gender, level of education/study, time spent in near vision, sports practice, medical history | Other | Atropine 0.01%, DIMS/HAL, Various combined treatments |
| Ophthalmological historyOphthalmological history: age of myopia discovery, parental refraction, previous refractions, presence of a braking treatment | Other | Atropine 0.01%, DIMS/HAL, Various combined treatments |
| Ophthalmological data at each examinationOphthalmological data at each examination: visual acuity, subjective refraction, cycloplegia with SKIACOL, axial length. | Other | Atropine 0.01%, DIMS/HAL, Various combined treatments |
| Potential adverse eventsPotential adverse events: halos, photophobia, stinging, infections, etc. | Other | Atropine 0.01%, DIMS/HAL, Various combined treatments |
Primary outcome
Database of active treatments for myopia
Time frame: Month 5
Database established with data from children or young adults with active myopia treated with ATROPINE 0.01% eye drops or myopia control spectacles or contact lenses, and their various combinations.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Marie-Caroline TRONE, Md principal investigator
CHU de Saint-Étienne
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 Centre Hospitalier Universitaire de Saint Etienne 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 1 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: finished, as of the sponsor's last update on 13 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Database of active treatments for myopia (time frame: Month 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 13 Aug 2025.