NCT07746778 School-based Myopia Control Trial for Children With Premyopia or Myopia
| NCT ID | NCT07746778 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Eye Disease Prevention and Treatment Center |
| Condition | Myopia |
| Study Type | INTERVENTIONAL |
| Enrollment | 358 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 358 participants in total. It began in 2026-06-01 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07746778 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 11 Years, studying Myopia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07746778 currently recruiting?
Yes, NCT07746778 is actively recruiting participants. Contact the research team at xianhezi@163.com for enrollment information.
Where is the NCT07746778 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07746778 clinical trial?
NCT07746778 is sponsored by Shanghai Eye Disease Prevention and Treatment Center. The trial plans to enroll 358 participants.