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

Sponsor
Shanghai Eye Disease Prevention and Treatment Center
Study ID
NCT07746778
Status
Recruiting
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Conditions

  • Myopia
  • Refractive Errors

Eligibility Criteria

Sex
ALL
Age
6 Years - 11 Years
Healthy Volunteers
Not accepted

Interventions

  • Defocus Spectacle Lenses — DEVICE
    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.
  • Auricular Acupressure — OTHER
    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.

Study Details

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.

Key Dates

First listed
Aug 5, 2026
Start date
Jun 1, 2026
Status verified
Jul 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
358 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Intervention Group
    Participants in the intervention group will receive defocus spectacle lenses combined with auricular acupressure during the 12-month study period. Defocus spectacle lenses will be prescribed and fitted according to standardized procedures. In addition, auricular acupressure will be performed by trained medical personnel according to the study protocol.
  • Active Comparator: Control Group
    Participants in the control group will receive defocus spectacle lenses alone during the 12-month study period. The lenses will be prescribed and fitted according to the same standardized procedures as those used in the intervention group, but participants will not receive auricular acupressure.

Primary Outcome Measure

Change in axial length from baseline to 12 months [ Time Frame: Baseline to 12 months ]

Central Contacts

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