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
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