NCT05732467

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 14, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 17, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

February 17, 2023

Status Verified

February 1, 2023

Enrollment Period

8 months

First QC Date

February 8, 2023

Last Update Submit

February 16, 2023

Conditions

Amblyopia

Keywords

amblyopiavirtual reality

Outcome Measures

Primary Outcomes (1)

  • Best corrected visual acuity

    16 weeks

Secondary Outcomes (2)

  • Near stereopsis

    16 weeks

  • contrast sensitivity

    16 weeks

Study Arms (2)

experimental group

EXPERIMENTAL
Device: visual function training softwareOther: corrective glasses

control group

OTHER
Other: occlusion therapyOther: corrective glasses

Interventions

visual function training softwareDEVICE

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)
experimental group
occlusion therapyOTHER

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.

control group
corrective glassesOTHER

corrective glasses

control groupexperimental group

Eligibility Criteria

Age4 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Amblyopia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVision DisordersSensation DisordersNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Xiajing Tang

    Second Affiliated Hospital, School of Medicine, Zhejiang University

    STUDY CHAIR

Central Study Contacts

Xiajing Tang

CONTACT

+86 13732227517xiajingtang@zju.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2023

First Posted

February 17, 2023

Study Start

November 14, 2022

Primary Completion

July 1, 2023

Study Completion

June 1, 2024

Last Updated

February 17, 2023

Record last verified: 2023-02

Locations

CN(1)