Acupuncture Intervention on the Brain and Vision Mechanism of Amblyopia Patients

Phase 1

Recruiting

• Conditions: Amblyopia in children and adolescents

• Registration Number: ITMCTR2100004369
• Lead Sponsor: Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
best corrected visual acuity;oxyhemoglobin;deoxyhemoglobin;Total hemoglobin;Diopter after pupil dilation;

Secondary Outcome Measures

Name	Time	Method
VEP;stereopsis;contrast sensitivity;PRA;NRA;