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Completed

NCT Number: NCT05732467

Effectiveness of Virtual Reality Training in Amblyopia

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.

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Key information

Conditions

Amblyopia Brain Diseases Central Nervous System Diseases Eye Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vision Disorders

Age range

4 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

visual function training software

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.

Other names: visual function training software (model: SJ-JRS2021)

Occlusion therapy

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

Other

corrective glasses

Primary outcomes

  1. Best corrected visual acuity

    Time frame: 16 weeks

Secondary outcomes

  1. Near stereopsis

    Time frame: 16 weeks

  2. contrast sensitivity

    Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Feb 17, 2023
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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