Effectiveness of Virtual Reality Training in Amblyopia

NCT ID: NCT05732467

Last Updated: 2023-02-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-14
• Study Completion Date: 2024-06-30

Brief Summary

The goal of this clinical trial is to evaluate the efficacy and safety of visual function training software (model: SJ-JRS2021) in the treatment of mild to moderate amblyopia in children. The main questions it aims to answer are:

• Whether virtual reality training is more effective than occlusion therapy
• Safety of virtual reality training in amblyopia treatment If participants have refractive problems, correct the refraction first and wear corrective glasses. The experimental group will be treated using visual function training therapy software (model: SJ-JRS2021). The control group will be treated with occlusion therapy covering the contralateral eye for 2 hours a day. Researchers will compare experimental group with control group to see if the experimental group has better corrected vision recovery.

Conditions

Amblyopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

experimental group

Group Type: EXPERIMENTAL

visual function training software

Intervention Type: DEVICE

Experimental group: If there is a refractive problem, first correct the refraction, wear corrective glasses, and then use visual function training therapy software (model: SJ-JRS2021) for treatment.

corrective glasses

Intervention Type: OTHER

corrective glasses

control group

Group Type: OTHER

occlusion therapy

Intervention Type: OTHER

Control group: If there is a refractive problem, correct the refraction first, wear corrective glasses combined with occlusion therapy, and cover the fellow eye for 2 hours a day.

corrective glasses

Intervention Type: OTHER

corrective glasses

Interventions

visual function training software

Experimental group: If there is a refractive problem, first correct the refraction, wear corrective glasses, and then use visual function training therapy software (model: SJ-JRS2021) for treatment.

Intervention Type: DEVICE

occlusion therapy

Control group: If there is a refractive problem, correct the refraction first, wear corrective glasses combined with occlusion therapy, and cover the fellow eye for 2 hours a day.

Intervention Type: OTHER

corrective glasses

corrective glasses

Intervention Type: OTHER

Other Intervention Names

visual function training software (model: SJ-JRS2021)

Eligibility Criteria

Inclusion Criteria

• Age 4-7 years old (including 4 and 7 years old), both sexes;
• Monocular amblyopia was diagnosed;
• The corrected visual acuity of amblyopia is between 0.2 (inclusive) and 0.6, and the binocular visual difference is more than 2 lines;
• The guardian of the subject can understand the purpose of the trial and sign the informed consent. The subject can cooperate with the treatment and related ophthalmic examination

Exclusion Criteria

• The subject has tumor, heart disease, hypertension and epilepsy;
• The subject has an implanted electronic device, such as a pacemaker;
• The subject has suffered from mental illness;
• Subject suffers from vertigo, fear of heights or brain trauma;
• The subject has photophobia and tears caused by keratitis, conjunctivitis, internal trichiasis and other diseases at any time;
• The subject has strabismus or congenital cataract, congenital ptosis, trauma and other ocular organic lesions and related surgical history;
• Subject has had any form of treatment for amblyopia other than refractive correction and covering treatment.
• Other conditions, such as severe heart, liver and kidney disease, under which the investigator considers that the patient should not participate in the trial for safety reasons or in the interest of the patient.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiajing Tang

Role: STUDY_CHAIR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Locations

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiajing Tang

Role: CONTACT

xiajingtang@zju.edu.cn

+86 13732227517

Facility Contacts

Xiajing Tang

Role: primary

xiajingtang@zju.edu.cn

+86 13732227517

Other Identifiers

2022-0755

Identifier Type: -

Identifier Source: org_study_id