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CompletedNCT05732467Updated Jun 1, 2026

Effectiveness of Virtual Reality Training in Amblyopia

An interventional study of visual function training software and occlusion therapy in Amblyopia, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Completed at 1 site in China. Open to participants aged 4 Years to 7 Years. Per ClinicalTrials.gov, last updated 2026-06-01.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
4 Years to 7 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Amblyopia

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Keywords

  • amblyopia
  • virtual reality
03

Who can participate

Ages eligible
4 Years to 7 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
90 participants (actual)

Study arms

  • Experimental
    experimental group

    Device: visual function training software · Other: corrective glasses

  • Other
    control group

    Other: occlusion therapy · Other: corrective glasses

Interventions

  • Devicevisual 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.

    Also known as: visual function training software (model: SJ-JRS2021)

  • Otherocclusion 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.

  • Othercorrective glasses

    corrective glasses

05

What researchers measure

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

06

Study locations

1 site
  • The Second Affiliated Hospital of Zhejiang University School of Medicine
    Hangzhou, Zhejiang, China
07

Registry details

Key details

Study ID
NCT05732467
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible party
Sponsor
First posted
Feb 17, 2023
Start date
Nov 14, 2022
Primary completion
Nov 8, 2023
Completion
Nov 8, 2024
Last update
Jun 1, 2026

Study contacts

Xiajing Tang
study chair · Second Affiliated Hospital, School of Medicine, Zhejiang University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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