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Study on the effective methods, technologies and supporting products’ program of integrated traditional Chinese and Western medicine for myopia in children

The effect of eye health-related behaviors intervention on myopia prevention and control based on Eye-Monitoring in children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052101
Enrollment
Unknown
Registered
2021-10-17
Start date
2021-10-18
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Myopia

Interventions

Control group:None
Reminder only group:Eye-Monitor vibration intervention
Reminder & feedback group:Eye-Monitor vibration combined with vision-related behaviors feedback intervention

Sponsors

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

Eligibility

Sex/Gender
All
Age
7 Years to 10 Years

Inclusion criteria

Inclusion criteria: 1. All children graded 2-4 (7-10 years of age) without organic lesions that affect their visual acuity in the selected school are included in our study; 2. Organic lesions are diagnosed based on clinical or laboratory evidence; 3. The intensity and environment of the children's eye use are similar; 4. Children and their guardian voluntarily sign informed consent forms.

Exclusion criteria

Exclusion criteria: 1. Individuals with organic lesions such as corneal, iris, lens, and fundus lesions that affect vision in both or one eye, as well as subjects with amblyopia; 2. Anisometropia ( >= 1.50D); 3. Any eye wtih astigmatism ( >= 2.50D); 4. Children under myopia-control treatments are excluded, including Long term use of traditional Chinese medicine external treatment methods (including acupuncture, electroacupuncture, tuina, moxibustion, ear acupressure, etc.), orthokeratology, rigid gas permeable contact lens, progressive multifocal spectacles, peripheral defocus spectacles, multifocal and defocus soft contact lenses, low concentration atropine eye drops, visual therapy and other related treatments that have not been terminated; 5. Individuals with severe systemic diseases, such as cardiovascular, cerebrovascular, liver, kidney, hematopoietic system, and mental disorders; 6. Individuals with communication disorders; 7. Individuals participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
The changes in spherical equivalent of right eye in one year ;

Secondary

MeasureTime frame
The changes in axial length of right eye;The percentage of children with newly developed myopia of right eye;Average duration of the eyes at close distance;Working distance;The head tilting angle;The light intensity;Fast myopic rate shift of right eye;Participant compliance;

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 6, 2026