MyopiaSPARKNCT07746778
School-based Myopia Control Trial for Children With Premyopia or Myopia
A study testing Defocus Spectacle Lenses and Auricular Acupressure in people with Myopia and Refractive Errors, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
Trial summary
This is a prospective, school-based randomized controlled trial designed to evaluate auricular acupressure combined with defocus spectacle lenses for myopia control in primary school students with premyopia or myopia. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Myopia, Refractive Errors
- What is being tested?
- Defocus Spectacle Lenses and Auricular Acupressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 358 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to Dec 2027
- 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 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Students in grades 1 to 4 from participating primary schools.
- Children with premyopia or myopia at baseline, defined as cycloplegic spherical equivalent refraction in the worse eye greater than -0.50 D and less than or equal to +0.75 D for premyopia, or less than or equal to -0.50 D for myopia.
- Written informed consent provided by a parent or legal guardian, and age-appropriate assent obtained from the child when applicable.
- Willingness to participate in baseline and follow-up assessments during the study period.
Who cannot join
- Strabismus, amblyopia, or other ocular abnormalities.
- Systemic disease or other medical conditions that may affect study participation.
- Has received any myopia prevention intervention in the past 3 months.
- Known skin sensitivity, local ear skin lesions, or other conditions judged unsuitable for auricular acupressure.
- Any other condition judged by the study doctors to make participation inappropriate.
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
Xiangui He, PhD, +86 021-62717733, xianhezi@163.com
Jingjing Wang, PhD, 13011220912, 13011220912@163.com
About this study
Official title: A Randomized Controlled Trial of Auricular Acupressure Combined With Defocus Spectacle Lenses for Myopia Control in Children With Premyopia or Myopia
This is a prospective, school-based randomized controlled trial designed to evaluate auricular acupressure combined with defocus spectacle lenses for myopia control in primary school students with premyopia or myopia. Enrolled students in grades 1 to 4 will be randomly assigned to either defocus spectacle lenses combined with auricular acupressure or defocus spectacle lenses alone. Outcomes will include changes in axial length and cycloplegic spherical equivalent refraction, adherence to the assigned intervention, and safety outcomes over 12 months.
Read the detailed description
This prospective, school-based randomized controlled trial will be conducted among primary school students with premyopia or myopia. Eligible participants are students in grades 1 to 4 from participating primary schools who meet the study criteria for premyopia or myopia based on cycloplegic spherical equivalent refraction and whose parents or legal guardians provide written informed consent.
Premyopia is defined as cycloplegic spherical equivalent refraction in the worse eye greater than -0.50 D and less than or equal to +0.75 D. Myopia is defined as cycloplegic spherical equivalent refraction in the worse eye less than or equal to -0.50 D.
Within each participating school, students will be stratified by grade and randomly assigned in a 1:1 ratio to the intervention group or the control group. The intervention group will receive defocus spectacle lenses combined with auricular acupressure according to the study protocol. The control group will receive defocus spectacle lenses alone according to the study protocol. Defocus spectacle lenses will be prescribed and fitted according to standardized procedures. Auricular acupressure will be delivered by trained medical personnel using auricular acupressure patches applied to selected auricular acupoints according to the standardized study protocol.
Comprehensive ophthalmic examinations will be conducted at baseline and 12 months according to the study protocol. An interim follow-up visit will be conducted at 6 months, including visual acuity assessment, non-cycloplegic autorefraction, and axial length measurement. The primary outcome is the change in axial length from baseline to 12 months. Secondary outcomes include the change in cycloplegic spherical equivalent refraction, adherence to the assigned intervention, and safety outcomes and adverse events.
- Conditions
- Myopia, Refractive Errors
- Being tested
- Defocus Spectacle Lenses, Auricular Acupressure
- Keywords
- Myopia Control, Premyopia, Defocus Spectacle Lenses, Auricular Acupressure, Axial Length
- Medical subject headings
- Myopia, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Defocus Spectacle LensesDevice
Defocus spectacle lenses will be prescribed and fitted for eligible participants according to standardized procedures. The lenses are designed to provide refractive correction while introducing peripheral myopic defocus for myopia control. Participants with premyopia will be instructed to wear the spectacles for at least 8 hours per day, while participants with myopia will be instructed to wear them for at least 12 hours per day. Lens fitting, adaptation, follow-up, and any lens or frame adjustments will be monitored and documented during the study period. If adjustments are required due to discomfort, prescription change, poor fit, or lens/frame damage, they will be managed according to standardized procedures whenever feasible. Participants will remain in their originally assigned group for the primary intention-to-treat analysis, and lens-wear adherence and major lens adjustments may be considered in per-protocol or sensitivity analyses.
Auricular AcupressureOther
Auricular acupressure will be performed using auricular acupressure patches applied to selected auricular acupoints, including liver, spleen, heart, eye, kidney, Mu 1, Mu 2, and Shenmen. The intervention will be delivered once per week by trained medical personnel according to a standardized protocol. Each application will remain in place for 5 days, followed by a 2-day rest period, with the treated ear alternated weekly. Participants will be instructed to press the patches three times daily, in the morning, at noon, and before bedtime, with 10 to 20 presses each time. Adherence to auricular acupressure will be assessed based on attendance at scheduled sessions, patch retention, and completion of participant pressing instructions recorded by study personnel or school health teachers. If patches fall off, loosen, or cause local discomfort, the school health teacher or study personnel will be informed and appropriate management will be provided.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants in the intervention group will receive defocus spectacle lenses combined with auricular acupressure during the 12-month study period. Defocus spectacle lenses will be prescribed and fitted according to standardized procedures. In addition, auricular acupressure will be performed by trained medical personnel according to the study protocol. Receives: Device: Defocus Spectacle Lenses; Other: Auricular Acupressure |
| Control Group | Active comparator | Participants in the control group will receive defocus spectacle lenses alone during the 12-month study period. The lenses will be prescribed and fitted according to the same standardized procedures as those used in the intervention group, but participants will not receive auricular acupressure. Receives: Device: Defocus Spectacle Lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in axial length from baseline to 12 months
Change in axial length is defined as the difference between axial length measured at 12 months and axial length measured at baseline.
Measured: Baseline to 12 months
Secondary outcomes (3)
Change in cycloplegic spherical equivalent refraction from baseline to 12 months
Change in cycloplegic spherical equivalent refraction is defined as the difference between the 12-month value and the baseline value.
Measured: Baseline to 12 months
Adherence to the assigned intervention
Defined as adherence to the assigned intervention during the study period, including attendance at scheduled auricular acupressure sessions, patch retention, completion of participant pressing instructions, and spectacle lens wear as applicable.
Measured: During the 12-month follow-up period
Safety outcomes and adverse events
Defined as the occurrence of any adverse events related to auricular acupressure or defocus spectacle lens wear, including local skin irritation, allergy, pain, itching, redness, swelling, ear discomfort, visual discomfort, dizziness, or other spectacle-related discomfort.
Measured: During the 12-month follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start1 Jun 2026
- Primary completionJun 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.
- 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
- Participants will be stratified by grade within each participating school and randomly assigned in a 1:1 ratio to either the intervention group or the control group. For continuous outcomes, including changes in axial length and cycloplegic spherical equivalent refraction, linear mixed-effects models will be used to account for potential clustering within schools and repeated measurements over time. For binary outcomes, including adherence to the assigned intervention and adverse events, mixed-effects logistic regression models or generalized estimating equations will be used as appropriate. Sensitivity analyses will be conducted to assess the robustness of the findings under different assumptions regarding clustering effects.
- Masking
- None (open label)
- Enrolment
- 358 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
- NCT07746778
- Sponsor's protocol ID
- KY2026-001-RE-013
- Acronym
- SPARK
- Status last verified
- Jul 2026
- First submitted
- 31 Jul 2026
- Last updated
- 5 Aug 2026
- 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 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Auricular Acupressure Combined With Defocus Spectacle Lenses for Myopia Control in Children With Premyopia or Myopia
- ClinicalTrials.gov ID
- NCT07746778
- Acronym / sponsor ID
- SPARK / KY2026-001-RE-013
- Conditions
- Myopia, Refractive Errors
- Keywords
- Myopia Control, Premyopia, Defocus Spectacle Lenses, Auricular Acupressure, Axial Length
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 358 participants (estimated)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 Aug 2026 (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.
This is a prospective, school-based randomized controlled trial designed to evaluate auricular acupressure combined with defocus spectacle lenses for myopia control in primary school students with premyopia or myopia. Enrolled students in grades 1 to 4 will be randomly assigned to either defocus spectacle lenses combined with auricular acupressure or defocus spectacle lenses alone. Outcomes will include changes in axial length and cycloplegic spherical equivalent refraction, adherence to the assigned intervention, and safety outcomes over 12 months.
Detailed description
This prospective, school-based randomized controlled trial will be conducted among primary school students with premyopia or myopia. Eligible participants are students in grades 1 to 4 from participating primary schools who meet the study criteria for premyopia or myopia based on cycloplegic spherical equivalent refraction and whose parents or legal guardians provide written informed consent.
Premyopia is defined as cycloplegic spherical equivalent refraction in the worse eye greater than -0.50 D and less than or equal to +0.75 D. Myopia is defined as cycloplegic spherical equivalent refraction in the worse eye less than or equal to -0.50 D.
Within each participating school, students will be stratified by grade and randomly assigned in a 1:1 ratio to the intervention group or the control group. The intervention group will receive defocus spectacle lenses combined with auricular acupressure according to the study protocol. The control group will receive defocus spectacle lenses alone according to the study protocol. Defocus spectacle lenses will be prescribed and fitted according to standardized procedures. Auricular acupressure will be delivered by trained medical personnel using auricular acupressure patches applied to selected auricular acupoints according to the standardized study protocol.
Comprehensive ophthalmic examinations will be conducted at baseline and 12 months according to the study protocol. An interim follow-up visit will be conducted at 6 months, including visual acuity assessment, non-cycloplegic autorefraction, and axial length measurement. The primary outcome is the change in axial length from baseline to 12 months. Secondary outcomes include the change in cycloplegic spherical equivalent refraction, adherence to the assigned intervention, and safety outcomes and adverse events.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be stratified by grade within each participating school and randomly assigned in a 1:1 ratio to either the intervention group or the control group. For continuous outcomes, including changes in axial length and cycloplegic spherical equivalent refraction, linear mixed-effects models will be used to account for potential clustering within schools and repeated measurements over time. For binary outcomes, including adherence to the assigned intervention and adverse events, mixed-effects logistic regression models or generalized estimating equations will be used as appropriate. Sensitivity analyses will be conducted to assess the robustness of the findings under different assumptions regarding clustering effects.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: Defocus Spectacle Lenses, Other: Auricular AcupressureParticipants in the intervention group will receive defocus spectacle lenses combined with auricular acupressure during the 12-month study period. Defocus spectacle lenses will be prescribed and fitted according to standardized procedures. In addition, auricular acupressure will be performed by trained medical personnel according to the study protocol. |
| Control Group | Active comparator | Device: Defocus Spectacle LensesParticipants in the control group will receive defocus spectacle lenses alone during the 12-month study period. The lenses will be prescribed and fitted according to the same standardized procedures as those used in the intervention group, but participants will not receive auricular acupressure. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Students in grades 1 to 4 from participating primary schools.
- Children with premyopia or myopia at baseline, defined as cycloplegic spherical equivalent refraction in the worse eye greater than -0.50 D and less than or equal to +0.75 D for premyopia, or less than or equal to -0.50 D for myopia.
- Written informed consent provided by a parent or legal guardian, and age-appropriate assent obtained from the child when applicable.
- Willingness to participate in baseline and follow-up assessments during the study period.
Key exclusion criteria (5 listed)
- Strabismus, amblyopia, or other ocular abnormalities.
- Systemic disease or other medical conditions that may affect study participation.
- Has received any myopia prevention intervention in the past 3 months.
- Known skin sensitivity, local ear skin lesions, or other conditions judged unsuitable for auricular acupressure.
- Any other condition judged by the study doctors to make participation inappropriate.
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 |
|---|---|---|
| Defocus Spectacle LensesDefocus spectacle lenses will be prescribed and fitted for eligible participants according to standardized procedures. The lenses are designed to provide refractive correction while introducing peripheral myopic defocus for myopia control. Participants with premyopia will be instructed to wear the spectacles for at least 8 hours per day, while participants with myopia will be instructed to wear them for at least 12 hours per day. Lens fitting, adaptation, follow-up, and any lens or frame adjustments will be monitored and documented during the study period. If adjustments are required due to discomfort, prescription change, poor fit, or lens/frame damage, they will be managed according to standardized procedures whenever feasible. Participants will remain in their originally assigned group for the primary intention-to-treat analysis, and lens-wear adherence and major lens adjustments may be considered in per-protocol or sensitivity analyses. | Device | Control Group, Intervention Group |
| Auricular AcupressureAuricular acupressure will be performed using auricular acupressure patches applied to selected auricular acupoints, including liver, spleen, heart, eye, kidney, Mu 1, Mu 2, and Shenmen. The intervention will be delivered once per week by trained medical personnel according to a standardized protocol. Each application will remain in place for 5 days, followed by a 2-day rest period, with the treated ear alternated weekly. Participants will be instructed to press the patches three times daily, in the morning, at noon, and before bedtime, with 10 to 20 presses each time. Adherence to auricular acupressure will be assessed based on attendance at scheduled sessions, patch retention, and completion of participant pressing instructions recorded by study personnel or school health teachers. If patches fall off, loosen, or cause local discomfort, the school health teacher or study personnel will be informed and appropriate management will be provided. | Other | Intervention Group |
Primary outcome
Change in axial length from baseline to 12 months
Time frame: Baseline to 12 months
Change in axial length is defined as the difference between axial length measured at 12 months and axial length measured at baseline.
3 secondary outcomes
Change in cycloplegic spherical equivalent refraction from baseline to 12 months
Time frame: Baseline to 12 months
Adherence to the assigned intervention
Time frame: During the 12-month follow-up period
Safety outcomes and adverse events
Time frame: During the 12-month follow-up period
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 5 Aug 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Defocus Spectacle Lenses and Auricular Acupressure in people with Myopia and Refractive Errors, 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 4 inclusion and 5 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 5 Aug 2026. 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, PhD (+86 021-62717733, xianhezi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in axial length from baseline to 12 months (time frame: Baseline to 12 months). 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 5 Aug 2026.