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Changes in the range and extent of neural activity in area V1 in amblyopic children treated with binocular schlieren and monocular masking

Changes in the range and extent of neural activity in area V1 in amblyopic children treated with binocular schlieren and monocular masking

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077880
Enrollment
Unknown
Registered
2023-11-22
Start date
2023-12-01
Completion date
Unknown
Last updated
2023-11-27

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

Conditions

Amblyopia

Interventions

normal control group:none
Monocular masking treatment group:Perform monocular occlusion therapy for 2h per day, at least 5 days per week, for 12 weeks of maintenance therapy
Binocular vision treatment group :Home training of amblyopic patients in binocular vision therapy using the Amblyopia Binocular Vision Therapy System for 1.5 hours per day, at least five days per week

Sponsors

Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 18 Years

Inclusion criteria

Inclusion criteria: Normal control group: 1) 6-18 years old, subject to his/her written consent, and gender-neutral; 2) Best-corrected visual acuity = 1.0 in both eyes; difference in visual acuity between eyes = 2 lines. Experimental group: 1) 6-18 years old, subject to their written consent, gender is not limited; (2) Monocular refractive amblyopia: best-corrected visual acuity =0.6 in the amblyopic eye, visual acuity =0.8 in the contralateral eye; visual acuity difference =2 lines between eyes. Visual acuity difference between two eyes = 2 lines; (3) Have normal thinking and language communication ability, and can actively cooperate with the treatment as required; (4) Parents agree to be randomized and sign an informed consent form. A personally signed and dated informed consent form A personally signed and dated informed consent form indicates that the patient (or legal representative) has been informed of all relevant information about the study.

Exclusion criteria

Exclusion criteria: 1) Presence of organic lesions that cause reduced visual acuity; 2) Paracentric gaze; 3) Systemic diseases affecting intelligence, etc; 4) Other conditions that, in the judgment of the investigator, make participation in the study unsuitable.

Design outcomes

Primary

MeasureTime frame
Changes in the degree and extent of neural activity in area V1;

Secondary

MeasureTime frame
Changes in vision and visual function;

Countries

China

Contacts

Public ContactHong Liu

Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine

liuhongzef@263.net+86 189 1778 5745

Outcome results

None listed

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