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Acupuncture Intervention on the Brain and Vision Mechanism of Amblyopia Patients

Acupuncture Intervention on the Brain and Vision Mechanism of Amblyopia Patients

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100004369
Enrollment
Unknown
Registered
2021-02-01
Start date
2021-02-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Amblyopia in children and adolescents

Interventions

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. Age: 6-12 years old; 2. Anisometropic amblyopia should meet at least one of the following criteria: a. After cycloplegia, the difference between the equivalent spherical degrees of the eyes in refraction is >= 1.50 D. b. After ciliary muscle paralysis, the difference between the optometry and the cylinder lens is >= 1.00 D. 3. Vision: a. The best corrected visual acuity for amblyopic eyes is between 0.1 and 0.8. b. The visual acuity difference between the two eyes is more than 2 lines. 4. There are no other organic diseases affecting vision in both eyes, and form deprivation factors (leukoplakia, congenital cataract, complete ptosis, etc.) are excluded. 5. Informed consent, and voluntarily sign the informed consent, in line with ethical standards; the process of obtaining the informed consent should comply with GCP regulations. Only those who meet the above conditions can be selected.

Exclusion criteria

Exclusion criteria: 1. After ciliary muscle paralysis, the equivalent spherical degree of refraction is <= -6.0D. 2. Patients with organic eye diseases that can cause form deprivation, such as corneal leukoplakia, congenital cataracts, and complete ptosis. 3. According to the judgment of the investigator, other lesions that reduce the possibility of enrollment or complicate enrollment are likely to cause loss to follow-up. 4. Patients with mental or legal disabilities. 5. Those who are participating in other clinical trials. If one of the above matches, it will be excluded.

Design outcomes

Primary

MeasureTime frame
best corrected visual acuity;oxyhemoglobin;deoxyhemoglobin;Total hemoglobin;Diopter after pupil dilation;

Secondary

MeasureTime frame
VEP;stereopsis;contrast sensitivity;PRA;NRA;

Countries

China

Contacts

Public ContactHongsheng Bi

Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine

hongshengbi@163.com+86 13698636748

Outcome results

None listed

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