Myopic ChildrenNCT06860737
A Randomized Clinical Trial on the Effectiveness of Novel Plano Spectacle Lenses on Myopia Prevention in Pre-myopic Children
A study testing Novel plano spectacle lenses in people with Myopic Children, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
Trial summary
Evaluate the efficacy, safety and wearing time compliance of novel plano spectacle lenses in delaying myopia onset in pre-myopic children and provide scientific basis for the development of myopia prevention strategies for children. Read more about this study
- Who is it for?
- Ages 6 to 9 years
- Conditions the study is for
- Myopic Children
- What is being tested?
- Novel plano spectacle lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 388 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2025to Jun 2026
- 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 6 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- At the time of signing the informed consent form, the subject's age must be ≥6 years and <10 years (6-9.99 years);
- Both eyes are not myopic (SE>-0.50D under cycloplegia) and at least one eye meets the pre-myopia condition ( -0.50D< SE under cycloplegia ≤+0.75D); [spherical equivalent (SE)=Sph+Cyl/2]
- Astigmatism ≤1.00D in each eye;
- Difference in SER (Anisometropia) between the two eyes should not exceed ≤1.50D;
- Unaided distance and near visual acuity of at least 0.1 logMAR in each eye ;
- Be in good general health;
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- Be able to actively cooperate with the intervention plan and ophthalmological examination;
- Normal binocular vision
- At least one parent with SER ≤-3.00 D
Who cannot join
- Incapable of expressing consent
- All categories of persons particularly protected by law
- Subject in another study which might have an influence on vision or interfere with study assessment.
- Previous use of other prevention solutions, such as but not limited to red light therapy within 6 months, Atropine and other interventions were used within 3 months;
- History or presence of an ocular disease, systemic disease, strabismus or amblyopia or other binocular vision abnormalities, accommodation dysfunction, cataract and eye surgery;
- Those who are allergic cycloplegic drugs;
- Other reasons that the investigator considers inappropriate for inclusion in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Clinical Trial on the Effectiveness of Novel Spectacle Lenses for Myopia Prevention in Pre-myopic Children
Evaluate the efficacy, safety and wearing time compliance of novel plano spectacle lenses in delaying myopia onset in pre-myopic children and provide scientific basis for the development of myopia prevention strategies for children.
Read the detailed description
Children aged 6-9 years old with pre-myopia are randomly assigned to a control group and an intervention group at a 1:1 ratio. The intervention group uses novel plano spectacle lenses for at least 8 hours a day, and the control group doesn't receive any intervention. The efficacy of novel plano spectacle lenses in delaying myopia onset in pre-myopia children is evaluated by comparing the one-year incidence of myopia onset between intervention group and control group.
- Conditions
- Myopic Children
- Being tested
- Novel plano spectacle lenses
- Keywords
- pre-myopic children, evaluation, intervention, comliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel plano spectacle lensesDevice
Use of novel plano spectacle lenses for at least 8 hours a day with objective wearing time measured by smart frame and objective outdoor time measured by smart bracelet.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Use of novel plano spectacle lenses for at least 8 hours a day with objective wearing time measured by smart frame and objective outdoor time measured by smart bracelet. Receives: Device: Novel plano spectacle lenses |
| Control group | No intervention | Objectively measuring outdoor time by smart bracelet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
One-year cumulative myopia incidence in either eye
One-year cumulative myopia incidence in either eye
Measured: From enrollment to the end of intervention for one year
Secondary outcomes (8)
Changes of spherical equivalent under cycloplegia
Changes of spherical equivalent under cycloplegia
Measured: From enrollment to the end of intervention for one year
Changes of axial length
Changes of axial length
Measured: From enrollment to the end of intervention for one year
Changes of choroidal thickness
Changes of choroidal thickness
Measured: From enrollment to the end of intervention for one year
Changes of unaided distance visual acuity
Changes of unaided distance visual acuity
Measured: From enrollment to the end of intervention for one year
Changes of visual acuity with novel spectacle lenses and Single Vision spectacle lenses
Changes of visual acuity with novel spectacle lenses and Single Vision spectacle lenses
Measured: From enrollment to the end of intervention for one year
Changes of accommodation function
Changes of accommodation function
Measured: From enrollment to the end of intervention for one year
Wearing time recorded in the questionnaire and smart frame
Wearing time recorded in the questionnaire and smart frame
Measured: From enrollment to the end of intervention for one year
Objective outdoor time recorded with smart bracelet
Objective outdoor time recorded with smart bracelet
Measured: From enrollment to the end of intervention for one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start15 Mar 2025
- Primary completionApr 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myopic ChildrenStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Children aged 6-9 years old with pre-myopia are randomly assigned to a control group and an intervention group at a 1:1 ratio. The intervention group uses novel plano spectacle lenses for at least 8 hours a day, and the control group doesn't receive any intervention. The efficacy of novel plano spectacle lenses in delaying myopia onset in pre-myopia children is evaluated by comparing the one-year incidence of myopia onset between intervention group and control group.
- Masking
- None (open label)
- Enrolment
- 388 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment Center
- Sponsor type
- University, hospital or other
- Collaborators
- Essilor International
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06860737
- Sponsor's protocol ID
- WS10405
- Status last verified
- Mar 2025
- First submitted
- 2 Mar 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang J, Du L, Chen J, Zhang B, Yang J, Du Y, Gao W, Zou H, Xu X, He X. A randomized clinical trial on the effectiveness of plano spectacle lenses with lenslets on myopia prevention in pre-myopic children: Study protocol of a randomized controlled trial. Acta Ophthalmol. 2026 May;104(3):e329-e336. doi: 10.1111/aos.70007. Epub 2025 Sep 21.
PubMed 40976937
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial on the Effectiveness of Novel Spectacle Lenses for Myopia Prevention in Pre-myopic Children
- ClinicalTrials.gov ID
- NCT06860737
- Acronym / sponsor ID
- WS10405
- Conditions
- Myopic Children
- Keywords
- pre-myopic children, evaluation, intervention, comliance
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 388 participants (estimated)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Collaborators
- Essilor International
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 6 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.
Evaluate the efficacy, safety and wearing time compliance of novel plano spectacle lenses in delaying myopia onset in pre-myopic children and provide scientific basis for the development of myopia prevention strategies for children.
Detailed description
Children aged 6-9 years old with pre-myopia are randomly assigned to a control group and an intervention group at a 1:1 ratio. The intervention group uses novel plano spectacle lenses for at least 8 hours a day, and the control group doesn't receive any intervention. The efficacy of novel plano spectacle lenses in delaying myopia onset in pre-myopia children is evaluated by comparing the one-year incidence of myopia onset between intervention group and control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Children aged 6-9 years old with pre-myopia are randomly assigned to a control group and an intervention group at a 1:1 ratio. The intervention group uses novel plano spectacle lenses for at least 8 hours a day, and the control group doesn't receive any intervention. The efficacy of novel plano spectacle lenses in delaying myopia onset in pre-myopia children is evaluated by comparing the one-year incidence of myopia onset between intervention group and control group.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Novel plano spectacle lensesUse of novel plano spectacle lenses for at least 8 hours a day with objective wearing time measured by smart frame and objective outdoor time measured by smart bracelet. |
| Control group | No intervention | –Objectively measuring outdoor time by smart bracelet. |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- At the time of signing the informed consent form, the subject's age must be ≥6 years and <10 years (6-9.99 years);
- Both eyes are not myopic (SE>-0.50D under cycloplegia) and at least one eye meets the pre-myopia condition ( -0.50D< SE under cycloplegia ≤+0.75D); [spherical equivalent (SE)=Sph+Cyl/2]
- Astigmatism ≤1.00D in each eye;
- Difference in SER (Anisometropia) between the two eyes should not exceed ≤1.50D;
- Unaided distance and near visual acuity of at least 0.1 logMAR in each eye ;
Key exclusion criteria (7 listed)
- Incapable of expressing consent
- All categories of persons particularly protected by law
- Subject in another study which might have an influence on vision or interfere with study assessment.
- Previous use of other prevention solutions, such as but not limited to red light therapy within 6 months, Atropine and other interventions were used within 3 months;
- History or presence of an ocular disease, systemic disease, strabismus or amblyopia or other binocular vision abnormalities, accommodation dysfunction, cataract and eye surgery;
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 |
|---|---|---|
| Novel plano spectacle lensesUse of novel plano spectacle lenses for at least 8 hours a day with objective wearing time measured by smart frame and objective outdoor time measured by smart bracelet. | Device | Intervention group |
Primary outcome
One-year cumulative myopia incidence in either eye
Time frame: From enrollment to the end of intervention for one year
One-year cumulative myopia incidence in either eye
8 secondary outcomes
Changes of spherical equivalent under cycloplegia
Time frame: From enrollment to the end of intervention for one year
Changes of axial length
Time frame: From enrollment to the end of intervention for one year
Changes of choroidal thickness
Time frame: From enrollment to the end of intervention for one year
Changes of unaided distance visual acuity
Time frame: From enrollment to the end of intervention for one year
Changes of visual acuity with novel spectacle lenses and Single Vision spectacle lenses
Time frame: From enrollment to the end of intervention for one year
Changes of accommodation function
Time frame: From enrollment to the end of intervention for one year
Wearing time recorded in the questionnaire and smart frame
Time frame: From enrollment to the end of intervention for one year
Objective outdoor time recorded with smart bracelet
Time frame: From enrollment to the end of intervention for one year
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 8 Dec 2025.
- Derived from this study: PubMed 40976937Wang J, Du L, Chen J, Zhang B, Yang J, Du Y, Gao W, Zou H, Xu X, He X. A randomized clinical trial on the effectiveness of plano spectacle lenses with lenslets on myopia prevention in pre-myopic children: Study protocol of a randomized controlled trial. Acta Ophthalmol. 2026 May;104(3):e329-e336. doi: 10.1111/aos.70007. Epub 2025 Sep 21.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel plano spectacle lenses in people with Myopic Children, 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 9 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 8 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 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?
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?
One-year cumulative myopia incidence in either eye (time frame: From enrollment to the end of intervention for one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06860737, which also lists 1 linked publication.
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 8 Dec 2025; AzTrials last refreshed its copy on 7 Nov 2026.