Hyperopia, Myopia, Refractive Errors
Conditions
Keywords
Myopia Prevention, Auricular Acupressure, Hyperopic Reserve, Axial Length
Brief 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. 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.
Interventions
OTHERAuricular Acupressure
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.
BEHAVIORALEye Health Education
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.
Sponsors
Shanghai Eye Disease Prevention and Treatment Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in axial length | Baseline to 12 months | Defined as the difference in axial length between the 12-month follow-up visit and baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in cycloplegic spherical equivalent refraction | Baseline to 12 months | Defined as the difference in cycloplegic spherical equivalent refraction between the 12-month follow-up visit and baseline. |
| Incidence of myopia during follow-up | During the 12-month follow-up period | 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. |
| Adherence to auricular acupressure | During the 12-month follow-up period | Defined as adherence to scheduled auricular acupressure sessions during the study period. |
| Safety Outcomes and Adverse Events | During the 12-month follow-up period | 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. |
Countries
China
Contacts
CONTACTXiangui He, PhD
CONTACTJingjing Wang, PhD
Outcome results
None listed