School-based Myopia Prevention Trial for Children With Insufficient Hyperopic Reserve

NCT07746804 | Recruiting

• 1 other identifier: KY2026-001-RE-012
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Refractive Errors; Hyperopia; Myopia

Keywords

Myopia Prevention; Auricular Acupressure; Hyperopic Reserve; Axial Length

Outcome Measures

Primary Outcomes (1)

• Change in axial length

  Defined as the difference in axial length between the 12-month follow-up visit and baseline.

  Baseline to 12 months

Secondary Outcomes (4)

• Change in cycloplegic spherical equivalent refraction

  Baseline to 12 months

• Incidence of myopia during follow-up

  During the 12-month follow-up period

• Adherence to auricular acupressure

  During the 12-month follow-up period

• Safety Outcomes and Adverse Events

  During the 12-month follow-up period

Study Arms (2)

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.

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.

Behavioral: Eye Health Education

Interventions

Auricular Acupressure OTHER

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.

Intervention Group

Eye Health Education BEHAVIORAL

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.

Control Group; Intervention Group

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Eye Disease Prevention and Treatment Center: lead

Study Sites (1)

Shanghai Eye Disease Prevention and Treatment Center

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Refractive Errors; Hyperopia; Myopia

Condition Hierarchy (Ancestors)

Eye Diseases

Central Study Contacts

Xiangui He, PhD

CONTACT

+86 021-62717733; xianhezi@163.com

Jingjing Wang, PhD

CONTACT

13011220912; 13011220912@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 5, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 5, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)