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A Randomized Controlled Study on the Effectiveness of KUBOTA spectacles in Preventing Myopia Onset in Children with Pre-Myopia

A Randomized Controlled Study on the Effectiveness of KUBOTA spectacles in Preventing Myopia Onset in Children with Pre-Myopia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112577
Enrollment
Unknown
Registered
2025-11-17
Start date
2025-11-20
Completion date
Unknown
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

Interventions

Test group 1:Wear KUBOTA spectacles for minimum 2 hours daily, at least 6days per week
Test group 2:Health education

Sponsors

Shanghai Eye Disease Prevention and Treatment Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 10 Years

Inclusion criteria

Inclusion criteria: 1.At the time of signing the informed consent form, the subject's age must be =6 years and -0.50D under cycloplegia) and at least one eye meets the pre-myopia condition ( -0.50D= 0.8; 6.Be in good general health; 7.Be able to actively cooperate with the intervention plan and ophthalmological examination.

Exclusion criteria

Exclusion criteria: 1.Incapable of expressing consent; 2. Subject in another study which might have an influence on vision or interfere with study assessment; 3. Previous use of other prevention solutions, such as but not limited to red light therapy, low concentration atropine and other interventions were used within 6 months; 4. History of eye surgery, strabismus, amblyopia, or ocular diseases; 5. Those who are allergic cycloplegic drugs; 6.Other reasons that the investigator considers inappropriate for inclusion in the study.

Design outcomes

Primary

MeasureTime frame
1-year change of axial length;

Secondary

MeasureTime frame
1-year cumulative myopia incidence;1-year change in spherical equivalent;Change in visual acuity;Change in choroidal thickness/ blood flow;Compliance;Adaptability;

Countries

China

Contacts

Public ContactXiangui He

Shanghai Eye Disease Prevention and Treatment Center

xianhezi@163.com+86 21 5355 5032

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026