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Effectiveness of Integrated Traditional Chinese and Western Medicine in the Comprehensive Intervention for Myopia in Children: A Pragmatic Cluster Randomized Controlled Trial

Effectiveness of Integrated Traditional Chinese and Western Medicine in the Comprehensive Intervention for Myopia in Children: A Pragmatic Cluster-Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108784
Enrollment
Unknown
Registered
2025-09-05
Start date
2025-09-22
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

Myopia

Interventions

Control group:Conventional Eye Health Education
Intervention Group:The intervention group received a comprehensive integrated Chinese and Western medicine intervention, which included: Eye-Monitor usage behavior management, myopia early warning for

Sponsors

Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: (1) Aged 6 to 12 years old; (2) Best corrected distance visual acuity >=1.0; (3) No other organic diseases affecting visual acuity were found in either eye; (4) Voluntarily participated in this clinical study after providing written informed consent.

Exclusion criteria

Exclusion criteria: (1) Participants with organic ocular diseases affecting vision in one or both eyes (e.g., cornea, iris, lens, or ocular fundus) and those with strabismus or amblyopia; (2) Subjects with a history of ocular trauma or previous eye surgery were excluded; (3) Severe systemic diseases (e.g., cardiovascular, cerebrovascular, hepatic, renal, hematopoietic, or psychiatric disorders); (4) Intellectual disability or communication impairment; (5) Current participation in other clinical trials.

Design outcomes

Primary

MeasureTime frame
The changes in axial length of right eyes;

Secondary

MeasureTime frame
The rate of myopia incidence in right eyes;Rapid Myopia Progression Rate of right eyes;

Countries

China

Contacts

Public ContactBi Hongsheng

Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine

hongshengbi1@163.com+86 139 5311 3696

Outcome results

None listed

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