MyopiaNCT04252989
Atropine 0.01% Eyedrops for Evolutive Myopia Treatment in Children
An observational study of Myopia and Children, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Prevalence of myopia and its complications has been increasing over the past decades, especially among children and adolescents. It reaches record levels in Asia: nearly 80% of the population in some regions in 2012 where the investigators speak in terms of epidemic. Read more about this study
- Who is it for?
- Ages Up to 18 years
- What is being tested?
- data collection
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 18 Dec 2019to Dec 2027
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with active myopia treated with ATROPINE 0.01% eye drops
Who may be able to join
- Children with active myopia treated with ATROPINE 0.01% eye drops
- patient affiliated with a social security organization
- agreement of both parents
Who cannot join
- non compliance with treatment
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
CHU de Saint Etienne
Saint-Etienne, 42055
Marie Caroline TRONE, MD, (0)4 77 82 92 72 ext. +33, m.caroline.trone@chu-st-etienne.fr
Philippe GAIN, MD PhD
About this study
Official title: Atropine 0.01% Eyedrops for Evolutive Myopia Treatment in Children. MYOPSTOP
Prevalence of myopia and its complications has been increasing over the past decades, especially among children and adolescents. It reaches record levels in Asia: nearly 80% of the population in some regions in 2012 where the investigators speak in terms of epidemic.
ATROPINE 0.01% eyedrops one drop per day is today an evolutive myopia treatment, whose results are promising.
The investigators use this eye drops in our clinical practice at hospital of Saint-Etienne since 2017.
Few clinical data have been published so far concerning the French population.
The investigators would like to build a database so that the investigators can publish our results and share our experience.
- Being tested
- data collection
- Keywords
- atropine
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data collectionOther
- Demographic data: age, sex
- Ophthalmological history: refraction of parents, previous refractions
- Ophthalmological data at each examination: intra-ocular pression, objective refraction after "fog", cycloplegia with SKIACOL, slit lamp, dilated eye exam, biometrics
- Potential undesirable events (halos, photophobia...)
| Study group | Role | What they receive |
|---|---|---|
| Children with active myopia treated with ATROPINE eye drops | Not described Receives: Other: data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
previous refractions
effectiveness of ATROPINE 0.01% eyedrops in our current clinical practice
Measured: every 6 months up to age 18 years
refraction of parents
effectiveness of ATROPINE 0.01% eyedrops in our current clinical practice
Measured: every 6 months up to age 18 years
intra-ocular pression
effectiveness of ATROPINE 0.01% eyedrops in our current clinical practice
Measured: every 6 months up to age 18 years
objective refraction after "fog"
effectiveness of ATROPINE 0.01% eyedrops in our current clinical practice
Measured: every 6 months up to age 18 years
cycloplegia with SKIACOL
effectiveness of ATROPINE 0.01% eyedrops in our current clinical practice
Measured: every 6 months up to age 18 years
slit lamp
effectiveness of ATROPINE 0.01% eyedrops in our current clinical practice
Measured: every 6 months up to age 18 years
dilated eye exam
effectiveness of ATROPINE 0.01% eyedrops in our current clinical practice
Measured: every 6 months up to age 18 years
biometrics
effectiveness of ATROPINE 0.01% eyedrops in our current clinical practice
Measured: every 6 months up to age 18 years
Secondary outcomes (1)
undesirable events collection
measured the tolerance of ATROPINE 0.01% eyedrops. Number of participants with treatment-related adverse events.
Measured: every 6 months up to age 18 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start18 Dec 2019
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (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 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
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie Caroline TRONE, Principal investigator, CHU de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04252989
- Sponsor's protocol ID
- IRBN962019/CHUSTE
- Status last verified
- Mar 2025
- First submitted
- 15 Jan 2020
- Last updated
- 18 Mar 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 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atropine 0.01% Eyedrops for Evolutive Myopia Treatment in Children. MYOPSTOP
- ClinicalTrials.gov ID
- NCT04252989
- Acronym / sponsor ID
- IRBN962019/CHUSTE
- Keywords
- atropine
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 18 Dec 2019 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 Feb 2020 (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.
Prevalence of myopia and its complications has been increasing over the past decades, especially among children and adolescents. It reaches record levels in Asia: nearly 80% of the population in some regions in 2012 where the investigators speak in terms of epidemic.
ATROPINE 0.01% eyedrops one drop per day is today an evolutive myopia treatment, whose results are promising.
The investigators use this eye drops in our clinical practice at hospital of Saint-Etienne since 2017.
Few clinical data have been published so far concerning the French population.
The investigators would like to build a database so that the investigators can publish our results and share our experience.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with active myopia treated with ATROPINE eye drops | – | Other: data collection |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with active myopia treated with ATROPINE 0.01% eye drops
Key inclusion criteria (3 listed)
- Children with active myopia treated with ATROPINE 0.01% eye drops
- patient affiliated with a social security organization
- agreement of both parents
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 |
|---|---|---|
| data collection* Demographic data: age, sex * Ophthalmological history: refraction of parents, previous refractions * Ophthalmological data at each examination: intra-ocular pression, objective refraction after "fog", cycloplegia with SKIACOL, slit lamp, dilated eye exam, biometrics * Potential undesirable events (halos, photophobia...) | Other | Children with active myopia treated with ATROPINE eye drops |
Primary outcome
previous refractions
Time frame: every 6 months up to age 18 years
effectiveness of ATROPINE 0.01% eyedrops in our current clinical practice
refraction of parents
Time frame: every 6 months up to age 18 years
effectiveness of ATROPINE 0.01% eyedrops in our current clinical practice
intra-ocular pression
Time frame: every 6 months up to age 18 years
effectiveness of ATROPINE 0.01% eyedrops in our current clinical practice
objective refraction after "fog"
Time frame: every 6 months up to age 18 years
effectiveness of ATROPINE 0.01% eyedrops in our current clinical practice
cycloplegia with SKIACOL
Time frame: every 6 months up to age 18 years
effectiveness of ATROPINE 0.01% eyedrops in our current clinical practice
slit lamp
Time frame: every 6 months up to age 18 years
effectiveness of ATROPINE 0.01% eyedrops in our current clinical practice
dilated eye exam
Time frame: every 6 months up to age 18 years
effectiveness of ATROPINE 0.01% eyedrops in our current clinical practice
biometrics
Time frame: every 6 months up to age 18 years
effectiveness of ATROPINE 0.01% eyedrops in our current clinical practice
1 secondary outcome
undesirable events collection
Time frame: every 6 months up to age 18 years
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 18 Mar 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.
Marie Caroline TRONE principal investigator
CHU de Saint Etienne
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 and Children, 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: looking for participants now, as of the sponsor's last update on 18 Mar 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 Marie Caroline TRONE (04 77 82 94 28 ext. +33, m.caroline.trone@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
previous refractions (time frame: every 6 months up to age 18 years). The study lists 8 primary outcomes in all. 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 18 Mar 2025.