School-based Myopia Control Trial for Children With Premyopia or Myopia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-11
SponsorShanghai Eye Disease Prevention and Treatment Center
About this trial
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.
Eligibility criteria
Qualifiers
Students in grades 1 to 4 from participating primary schools.
Children with premyopia or myopia at baseline, defined as cycloplegic spherical equivalent refraction in the worse eye greater than -0.50 D and less than or equal to +0.75 D for premyopia, or less than or equal to -0.50 D for myopia.
Written informed consent provided by a parent or legal guardian, and age-appropriate assent obtained from the child when applicable.
Willingness to participate in baseline and follow-up assessments during the study period.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Defocus Spectacle Lenses
- Auricular Acupressure
Treatment groups
358 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov