Refractive ErrorsSPARKNCT07746804
School-based Myopia Prevention Trial for Children With Insufficient Hyperopic Reserve
A study testing Auricular Acupressure and Eye Health Education in people with Refractive Errors and Hyperopia, 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 for myopia prevention in non-myopic primary school students with insufficient hyperopic reserve. Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Refractive Errors, Hyperopia, Myopia
- What is being tested?
- Auricular Acupressure and Eye Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 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
- Healthy volunteers accepted
- Child
Who may be able to join
- Students in grades 1 to 4 from participating primary schools.
- Non-myopic children with insufficient hyperopic reserve, defined as cycloplegic spherical equivalent refraction in the worse eye greater than +0.75 D and below the following age-specific upper limits: +1.72 D at age 6 years; +1.48 D at age 7 years; +1.19 D at age 8 years; +1.11 D at age 9 years; +0.92 D at age 10 years; and +0.83 D at age 11 years.
- Written informed consent provided by a parent or legal guardian, with 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 School-based Auricular Acupressure for Myopia Prevention in Non-myopic Children With Insufficient Hyperopic Reserve
This is a prospective, school-based randomized controlled trial designed to evaluate auricular acupressure for myopia prevention in non-myopic primary school students with insufficient hyperopic reserve. Enrolled students in grades 1 to 4 will be randomly assigned to either an auricular acupressure intervention or usual daily activities without additional study-related myopia prevention intervention. Outcomes will include changes in axial length and cycloplegic spherical equivalent refraction, incident myopia, intervention adherence, and safety outcomes over 12 months.
Read the detailed description
This prospective, school-based randomized controlled trial will be conducted among non-myopic children with insufficient hyperopic reserve. Eligible participants are students in grades 1 to 4 from participating primary schools who meet the eligibility criteria for insufficient hyperopic reserve and whose parents or legal guardians provide written informed consent.
Insufficient hyperopic reserve is defined as cycloplegic spherical equivalent refraction in the worse eye greater than +0.75 D but lower than the age-specific reference value for hyperopic reserve.
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 auricular acupressure administered according to the study protocol in addition to standard school-based eye health education. The control group will receive standard school-based eye health education only and will not receive auricular acupressure or other additional study-related myopia prevention intervention.
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, the incidence of myopia during follow-up, adherence to auricular acupressure, and safety outcomes and adverse events.
- Conditions
- Refractive Errors, Hyperopia, Myopia
- Being tested
- Auricular Acupressure, Eye Health Education
- Keywords
- Myopia Prevention, Auricular Acupressure, Hyperopic Reserve, Axial Length
- Medical subject headings
- Refractive Errors, Hyperopia, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular AcupressureOther
Auricular acupressure will be performed using adhesive patches containing vaccaria seeds applied to selected auricular acupoints, including liver, spleen, heart, eye, kidney, Mu 1, Mu 2, and Shenmen. The intervention will be delivered once weekly 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. 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.
Eye Health EducationBehavioural
Standard school-based eye health education will include general guidance on healthy visual behaviors, near-work habits, reading posture, lighting conditions, eye exercises, and regular eye examinations.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants in the intervention group will receive auricular acupressure for myopia prevention during the 12-month study period. The intervention will be delivered by trained medical personnel according to a standardized protocol. Receives: Other: Auricular Acupressure; Behavioral: Eye Health Education |
| Control Group | Active comparator | Participants in the control group will receive standard school-based eye health education and maintain their usual daily activities during the 12-month study period. They will not receive auricular acupressure or other additional study-related myopia prevention intervention. Receives: Behavioral: Eye Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in axial length
Defined as the difference in axial length between the 12-month follow-up visit and baseline.
Measured: Baseline to 12 months
Secondary outcomes (4)
Change in cycloplegic spherical equivalent refraction
Defined as the difference in cycloplegic spherical equivalent refraction between the 12-month follow-up visit and baseline.
Measured: Baseline to 12 months
Incidence of myopia during follow-up
Defined as the proportion of participants who develop myopia during the 12-month follow-up period. Myopia is defined as uncorrected visual acuity less than 5.0 in either eye and non-cycloplegic spherical equivalent refraction less than -0.50 D in either eye.
Measured: During the 12-month follow-up period
Adherence to auricular acupressure
Defined as adherence to scheduled auricular acupressure sessions during the study period.
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, including local skin irritation, allergy, pain, itching, redness, swelling, or other ear 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 Refractive ErrorsStudies 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 incident myopia, good adherence to auricular acupressure, and adverse events, mixed-effects logistic regression models or generalized estimating equations will be used as appropriate. Time-to-event analyses for incident myopia may be conducted using Kaplan-Meier curves and log-rank tests as exploratory analyses. Cox proportional hazards models may also be used to estimate hazard ratios and 95% confidence intervals, as appropriate.
- Masking
- None (open label)
- Enrolment
- 130 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
- NCT07746804
- Sponsor's protocol ID
- KY2026-001-RE-012
- 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 School-based Auricular Acupressure for Myopia Prevention in Non-myopic Children With Insufficient Hyperopic Reserve
- ClinicalTrials.gov ID
- NCT07746804
- Acronym / sponsor ID
- SPARK / KY2026-001-RE-012
- Conditions
- Refractive Errors, Hyperopia, Myopia
- Keywords
- Myopia Prevention, Auricular Acupressure, Hyperopic Reserve, Axial Length
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 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 for myopia prevention in non-myopic primary school students with insufficient hyperopic reserve. Enrolled students in grades 1 to 4 will be randomly assigned to either an auricular acupressure intervention or usual daily activities without additional study-related myopia prevention intervention. Outcomes will include changes in axial length and cycloplegic spherical equivalent refraction, incident myopia, intervention adherence, and safety outcomes over 12 months.
Detailed description
This prospective, school-based randomized controlled trial will be conducted among non-myopic children with insufficient hyperopic reserve. Eligible participants are students in grades 1 to 4 from participating primary schools who meet the eligibility criteria for insufficient hyperopic reserve and whose parents or legal guardians provide written informed consent.
Insufficient hyperopic reserve is defined as cycloplegic spherical equivalent refraction in the worse eye greater than +0.75 D but lower than the age-specific reference value for hyperopic reserve.
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 auricular acupressure administered according to the study protocol in addition to standard school-based eye health education. The control group will receive standard school-based eye health education only and will not receive auricular acupressure or other additional study-related myopia prevention intervention.
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, the incidence of myopia during follow-up, adherence to auricular acupressure, 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 incident myopia, good adherence to auricular acupressure, and adverse events, mixed-effects logistic regression models or generalized estimating equations will be used as appropriate. Time-to-event analyses for incident myopia may be conducted using Kaplan-Meier curves and log-rank tests as exploratory analyses. Cox proportional hazards models may also be used to estimate hazard ratios and 95% confidence intervals, as appropriate.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Auricular Acupressure, Behavioral: Eye Health EducationParticipants in the intervention group will receive auricular acupressure for myopia prevention during the 12-month study period. The intervention will be delivered by trained medical personnel according to a standardized protocol. |
| Control Group | Active comparator | Behavioral: Eye Health EducationParticipants in the control group will receive standard school-based eye health education and maintain their usual daily activities during the 12-month study period. They will not receive auricular acupressure or other additional study-related myopia prevention intervention. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Students in grades 1 to 4 from participating primary schools.
- Non-myopic children with insufficient hyperopic reserve, defined as cycloplegic spherical equivalent refraction in the worse eye greater than +0.75 D and below the following age-specific upper limits: +1.72 D at age 6 years; +1.48 D at age 7 years; +1.19 D at age 8 years; +1.11 D at age 9 years; +0.92 D at age 10 years; and +0.83 D at age 11 years.
- Written informed consent provided by a parent or legal guardian, with 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 |
|---|---|---|
| Auricular AcupressureAuricular acupressure will be performed using adhesive patches containing vaccaria seeds applied to selected auricular acupoints, including liver, spleen, heart, eye, kidney, Mu 1, Mu 2, and Shenmen. The intervention will be delivered once weekly 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. 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 |
| Eye Health EducationStandard school-based eye health education will include general guidance on healthy visual behaviors, near-work habits, reading posture, lighting conditions, eye exercises, and regular eye examinations. | Behavioural | Control Group, Intervention Group |
Primary outcome
Change in axial length
Time frame: Baseline to 12 months
Defined as the difference in axial length between the 12-month follow-up visit and baseline.
4 secondary outcomes
Change in cycloplegic spherical equivalent refraction
Time frame: Baseline to 12 months
Incidence of myopia during follow-up
Time frame: During the 12-month follow-up period
Adherence to auricular acupressure
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
Related trials for Refractive Errors
RecruitingPhase 3
A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control
Myopia
RecruitingPhase 4
Arcuate Incisions With Light Adjustable Lens for Astigmatism Correction in Lens Surgery
Astigmatism
Not yet recruiting
Evaluation of the Agreement Between Automated Program-Operated Phoropter Subjective Refraction and Optometrist-Performed Subjective Refraction
Refractive Errors
Not yet recruiting
Consistency of an Automated Subjective Refraction Program Between Personnel With Diverse Professional Backgrounds and Senior Optometrists
Refractive Errors
Recruiting
Evaluation of Orthokeratology Lenses With a 5MM Optic Zone Diameter
Myopia, Astigmatism
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 Auricular Acupressure and Eye Health Education in people with Refractive Errors and Hyperopia, 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 3 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 (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.