MyopiaEOMNCT07176949
Early-Onset Myopia Intervention Project
A study testing 0.01% atropine eye drops, 0.05% atropine eye drops and Spectacle lenses with highly aspherical lenslets in people with Myopia and Pre-myopia, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
Trial summary
The prevalence of myopia among children has been increasing year by year, which has become a globle public health issue. Studies have shown that defocusing lenses and atroping eyedrops can control the progression of myopia, but there is little evidence of its efficacy in myopia intervention of young pre-schoolers who… Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Myopia, Pre-myopia
- What is being tested?
- 0.01% atropine eye drops, 0.05% atropine eye drops and Spectacle lenses with highly aspherical lenslets
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 508 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 31 May 2028
- Phase
- Interventional
- 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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 3-6 years, gender unrestricted;
- Bilateral cycloplegic spherical equivalent (SE) ≤ +0.75 D, astigmatism ≤-2.5 D, anisometropia ≤2.5 D;
- Best corrected visual acuity: ≥0.5 for ages 3-5, ≥0.7 for age 6;
- Accept regular follow-up, written informed consent from guardians, verbal informed consent from children;
- Possess normal thinking and language communication skills, and can actively cooperate to wear spectacles as required.
Who cannot join
- Existence of strabismus or amblyopia or other binocular vision abnormalities, accommodation dysfunction, cataract and history of eye surgery;
- Any ocular or systemic disease that may affect vision and refractive development (e.g., Keratoconus, Marfan syndrome, retinopathy of prematurity, etc.);
- Current or previous use of other treatments for myopia intervention, such as pharmacological (atropine) and optical (orthokeratology lenses or DIMS spectacle lenses) approaches, interrupt use for at least 4 weeks;
- Allergy or contraindication to cycloplegic drugs;
- Epilepsy or other mental disorders unable to expressing consent;
- Other conditions deemed unsuitable for participation by the researcher.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Eye Disease Prevention and Treatment Center
Shanghai, Shanghai Municipality
Tianyu Cheng, Dr, +86 18817552005, s70444@126.com
About this study
Official title: Project on Myopia Surveillance and Intervention Services for Preschool Children in Shanghai
The prevalence of myopia among children has been increasing year by year, which has become a globle public health issue. Studies have shown that defocusing lenses and atroping eyedrops can control the progression of myopia, but there is little evidence of its efficacy in myopia intervention of young pre-schoolers who will face a greater risk of progression to high myopia later in life. Therefore, this study aims to evaluate the effectiveness and safety of spectacle lenses with highly aspherical lenslets (Essilor's Stellest) , as well as 0.01% and 0.05% low concentration atropine eyedrops in myopia intervention among young children aged 3-6.
- Conditions
- Myopia, Pre-myopia
- Being tested
- 0.01% atropine eye drops, 0.05% atropine eye drops, Spectacle lenses with highly aspherical lenslets
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.01% atropine eye dropsDrug
Participants will use 0.01% atropine eyedrops nightly for myopia control.
0.05% atropine eye dropsDrug
Participants will use 0.05% atropine eyedrops nightly for myopia control.
Spectacle lenses with highly aspherical lensletsDevice
These are a special type of eyeglass lenses designed primarily to slow down the progression of myopia (nearsightedness) in children. The center of the lens provides a clear correction for distance vision, just like regular glasses. The surrounding area contains hundreds of tiny, invisible, and highly aspherical (complex curved) microlenses. These microlenses create a special optical effect. While the child looks straight ahead clearly, peripheral light rays are focused in front of the retina. This is called "myopic defocus." Research suggests that this myopic defocus signal helps to control the excessive elongation of the eyeball, which is the main cause of myopia getting worse.
| Study group | Role | What they receive |
|---|---|---|
| No Intervention | No intervention | No intervention for myopia control |
| Spectacle Lenses with Highly Aspherical Lenslets | Experimental | Wearing spectacle lenses with highly aspherical lenslets for myopia control Receives: Device: Spectacle lenses with highly aspherical lenslets |
| 0.01% Atropine | Experimental | Nightly use of 0.01% atropine eyedrops for myopia control Receives: Drug: 0.01% atropine eye drops |
| 0.05% Atropine | Experimental | Nightly use of 0.05% atropine eyedrops for myopia control Receives: Drug: 0.05% atropine eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cycloplegic spherical equivalence
Measured by an auto-refractometer
Measured: 2 year
Secondary outcomes (3)
Changes in axial length
Measured by an IOL-Master
Measured: 2 years
Proportion of subjects with non-rapid myopia progression
Rapid myopia progression is defined as: spherical equivalence increase (become less positive or more negative refractive error) of any eye ≥ 0.5 D in half a year.
Measured: 2 years
The duration of non-rapid myopia progression
Rapid myopia progression is defined as: spherical equivalence increase (become less positive or more negative refractive error) of any eye ≥ 0.5 D in half a year.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start1 Jun 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion31 May 2028 (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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 508 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07176949
- Sponsor's protocol ID
- EC-20240712-11
- Acronym
- EOM
- Status last verified
- Sep 2025
- First submitted
- 10 Sep 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project on Myopia Surveillance and Intervention Services for Preschool Children in Shanghai
- ClinicalTrials.gov ID
- NCT07176949
- Acronym / sponsor ID
- EOM / EC-20240712-11
- Conditions
- Myopia, Pre-myopia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 508 participants (estimated)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 16 Sep 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 among children has been increasing year by year, which has become a globle public health issue. Studies have shown that defocusing lenses and atroping eyedrops can control the progression of myopia, but there is little evidence of its efficacy in myopia intervention of young pre-schoolers who will face a greater risk of progression to high myopia later in life. Therefore, this study aims to evaluate the effectiveness and safety of spectacle lenses with highly aspherical lenslets (Essilor's Stellest) , as well as 0.01% and 0.05% low concentration atropine eyedrops in myopia intervention among young children aged 3-6.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No Intervention | No intervention | –No intervention for myopia control |
| Spectacle Lenses with Highly Aspherical Lenslets | Experimental | Device: Spectacle lenses with highly aspherical lensletsWearing spectacle lenses with highly aspherical lenslets for myopia control |
| 0.01% Atropine | Experimental | Drug: 0.01% atropine eye dropsNightly use of 0.01% atropine eyedrops for myopia control |
| 0.05% Atropine | Experimental | Drug: 0.05% atropine eye dropsNightly use of 0.05% atropine eyedrops for myopia control |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age 3-6 years, gender unrestricted;
- Bilateral cycloplegic spherical equivalent (SE) ≤ +0.75 D, astigmatism ≤-2.5 D, anisometropia ≤2.5 D;
- Best corrected visual acuity: ≥0.5 for ages 3-5, ≥0.7 for age 6;
- Accept regular follow-up, written informed consent from guardians, verbal informed consent from children;
- Possess normal thinking and language communication skills, and can actively cooperate to wear spectacles as required.
Key exclusion criteria (6 listed)
- Existence of strabismus or amblyopia or other binocular vision abnormalities, accommodation dysfunction, cataract and history of eye surgery;
- Any ocular or systemic disease that may affect vision and refractive development (e.g., Keratoconus, Marfan syndrome, retinopathy of prematurity, etc.);
- Current or previous use of other treatments for myopia intervention, such as pharmacological (atropine) and optical (orthokeratology lenses or DIMS spectacle lenses) approaches, interrupt use for at least 4 weeks;
- Allergy or contraindication to cycloplegic drugs;
- Epilepsy or other mental disorders unable to expressing consent;
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 |
|---|---|---|
| 0.01% atropine eye dropsParticipants will use 0.01% atropine eyedrops nightly for myopia control. | Drug | 0.01% Atropine |
| 0.05% atropine eye dropsParticipants will use 0.05% atropine eyedrops nightly for myopia control. | Drug | 0.05% Atropine |
| Spectacle lenses with highly aspherical lensletsThese are a special type of eyeglass lenses designed primarily to slow down the progression of myopia (nearsightedness) in children. The center of the lens provides a clear correction for distance vision, just like regular glasses. The surrounding area contains hundreds of tiny, invisible, and highly aspherical (complex curved) microlenses. These microlenses create a special optical effect. While the child looks straight ahead clearly, peripheral light rays are focused in front of the retina. This is called "myopic defocus." Research suggests that this myopic defocus signal helps to control the excessive elongation of the eyeball, which is the main cause of myopia getting worse. | Device | Spectacle Lenses with Highly Aspherical Lenslets |
Primary outcome
Changes in cycloplegic spherical equivalence
Time frame: 2 year
Measured by an auto-refractometer
3 secondary outcomes
Changes in axial length
Time frame: 2 years
Proportion of subjects with non-rapid myopia progression
Time frame: 2 years
The duration of non-rapid myopia progression
Time frame: 2 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 16 Sep 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.01% atropine eye drops, 0.05% atropine eye drops and Spectacle lenses with highly aspherical lenslets in people with Myopia and Pre-myopia, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
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 5 inclusion and 6 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 16 Sep 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 China. 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 Xiangui He, Prof (+86 15000755422, xianhezi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in cycloplegic spherical equivalence (time frame: 2 year). 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 16 Sep 2025.