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A randomized controlled multicenter clinical study of Eye-TEAS intervention for pre-myopia

A randomized controlled multicenter clinical study of Eye-TEAS intervention for pre-myopia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039781
Enrollment
Unknown
Registered
2020-11-09
Start date
2021-02-24
Completion date
Unknown
Last updated
2024-10-28

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

Conditions

pre-myopia

Interventions

Intervention group:Eye-TEAS
Control group:Sham Eye-TEAS

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: Participants who meet the diagnostic criteria preliminary and also conformed all of the following conditions will be included: 1. Aged between 6 to 12 years old; 2. Subject has at least one eye with a refractive state of >-0.50 D and <=+0.75 D, astigmatism of equal or less than 1.50 D, and uncorrected visual acuity of equal or lower than 0.0 logMAR; 3. Participation is voluntarily and the parents or legal guardian of the children had signed the informed consent prior to inclusion.

Exclusion criteria

Exclusion criteria: Participants will be excluded from this trial if they have any of the following conditions: 1. Involved in any treatment for myopia, including orthokeratology, low-concentration atropine eye drops, medicine, acupuncture, electro-acupuncture, massage, moxibustion, ear acupuncture, vision training or other related treatments without termination; 2. Have serious systemic diseases, such as cardiovascular and cerebrovascular diseases, mental diseases, etc.; 3. Allergic to medical silicone; 4. According to the judgments of researchers, existing diseases or other situation which would reduce or complicate enrollment predispose to loss of follow-up; 5.Children with amblyopia, strabismus, corneal scar, cataract, glaucoma, ocular tumour, or other eye abnormalities were also excluded.

Design outcomes

Primary

MeasureTime frame
Incidence rate of myopia;

Secondary

MeasureTime frame
Uncorrected visual acuity;Cycloplegic spherical equivalent refraction;Axial length;Non-cycloplegic spherical equivalent refraction;Corneal curvature;Amplitude of accommodation;Accommodation facility;Incidence rate of myopia;

Countries

China

Contacts

Public ContactBi Hongsheng

Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine

hongshengbi@163.com+86 139 5311 3696

Outcome results

None listed

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