School-based Myopia Control Trial for Children With Premyopia or Myopia (NCT07746778) | Clinical Trial Compass
RecruitingNot Applicable
School-based Myopia Control Trial for Children With Premyopia or Myopia
China358 participantsStarted 2026-06-01
Plain-language 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.
Who can participate
Age range
6 Years – 11 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in axial length from baseline to 12 months
Timeframe: Baseline to 12 months
Trial details
NCT IDNCT07746778
SponsorShanghai Eye Disease Prevention and Treatment Center