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A multi-center randomized controlled clinical study on Eye-TEAS controlling myopia in children and adolescents

Clinical study on 'three level prevention and control' scheme of integrated traditional Chinese and Western medicine for myopia in children and adolescents

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039918
Enrollment
Unknown
Registered
2020-11-14
Start date
2020-11-10
Completion date
Unknown
Last updated
2021-02-22

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

Conditions

Myopia in children and adolescents

Interventions

Frame + false Eye-TEAS group:Frame + false Eye-TEAS
Frame + Eye-TEAS group:Frame + Eye-TEAS
Corneal plastic lens + False Eye-TEAS group:Corneal plastic lens + False Eye-TEAS
Eye-TEAS+ corneal plastic lens group:Eye-TEAS+ corneal plastic lens

Sponsors

Ophthalmic hospital affiliated to Shandong University of traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 14 Years

Inclusion criteria

Inclusion criteria: 1. Subjects aged 8-14 years old; 2. The uncorrected visual acuity of both eyes was less than 1.0, and the best corrected visual acuity of both eyes was more than or equal to 1.0; 3. Subjects with binocular cycloplegia had se - 6.00D; binocular column diopter < 1.50D; anisometropia < 1.0d; 4. Subjects with long-range and short-range obliquity ranging from - 12 to + 6 prism degrees; 5. Subjects with no other organic lesions affecting vision in both eyes; 6. The subjects who have informed consent and sign the informed consent voluntarily are in line with the code of ethics; the process of obtaining the informed consent should comply with the provisions of GCP. Only those who meet the above conditions can be selected.

Exclusion criteria

Exclusion criteria: 1. In the past half a year, the subjects who have been treated with external therapy of traditional Chinese medicine, orthokeratology lens, rigid gas permeable contact lens, progressive multifocal lens, peripheral defocusing control lens, multifocal soft contact lens, low concentration atropine eye drops, visual training and other related treatments without termination; 2. Subjects with contraindications of wearing orthokeratology lens; 3. Subjects with history of ocular surgery, trauma or chronic ocular diseases in both eyes or one eye; 4. Patients with serious systemic diseases, such as cardiovascular, cerebrovascular, liver, kidney, hematopoietic system and mental diseases; allergic constitution or allergic to medical silica gel; or chronic mental diseases or mental disorders; 4; 5. According to the judgment of the researcher, other lesions that reduce or complicate the possibility of enrollment are likely to cause loss of follow-up; 6. Subjects participating in other clinical trials; 7. The subjects who met the diagnosis, but could not adhere to the treatment under the objective conditions, had poor compliance, did not obey the follow-up arrangement, and were easy to lose the follow-up. If one of the above is met, it will be excluded.

Design outcomes

Primary

MeasureTime frame
Anterior and posterior diopter of pupil;axial length;

Secondary

MeasureTime frame
vision;

Countries

China

Contacts

Public ContactHongsheng Bi

Ophthalmic Hospital affiliated to Shandong University of Traditional Chinese Medicine

hongshengbi1@163.com+86 13953113696

Outcome results

None listed

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