Effectiveness of Virtual Reality Training in Amblyopia

Not Applicable

Recruiting

• Conditions: Amblyopia
• Interventions: Other: occlusion therapy; Device: visual function training software; Other: corrective glasses

• Registration Number: NCT05732467
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-14
• Status Verified: 2023-02
• Study First Submitted: 2023-02-08
• Study First Submitted QC: 2023-02-16
• Last Update Submitted: 2023-02-16
• Study First Posted: 2023-02-17
• Last Update Posted: 2023-02-17
• Primary Completion: 2023-07
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	occlusion therapy	-
experimental group	visual function training software	-
experimental group	corrective glasses	-
control group	corrective glasses	-

Primary Outcome Measures

Name	Time	Method
Best corrected visual acuity	16 weeks

Secondary Outcome Measures

Name	Time	Method
Near stereopsis	16 weeks
contrast sensitivity	16 weeks

Trial Locations

Locations (1)

The Second Affiliated Hospital of Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China