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School-based Myopia Control Trial for Children With Premyopia or Myopia

NCT07746778 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 358

Last updated 2026-08-05

No results posted yet for this study

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. 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.

Conditions

  • Myopia
  • Refractive Errors

Interventions

DEVICE

Defocus Spectacle Lenses

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.

OTHER

Auricular Acupressure

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.

Sponsors & Collaborators

  • Shanghai Eye Disease Prevention and Treatment Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2027-06-30
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07746778 on ClinicalTrials.gov