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Effectiveness of Virtual Reality Training in Amblyopia

Primary Purpose

Amblyopia

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
visual function training software
occlusion therapy
corrective glasses
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amblyopia focused on measuring amblyopia, virtual reality

Eligibility Criteria

4 Years - 7 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Second Affiliated Hospital of Zhejiang University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

experimental group

control group

Arm Description

Outcomes

Primary Outcome Measures

Best corrected visual acuity

Secondary Outcome Measures

Near stereopsis
contrast sensitivity

Full Information

First Posted
February 8, 2023
Last Updated
February 16, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT05732467
Brief Title
Effectiveness of Virtual Reality Training in Amblyopia
Official Title
Effectiveness of Virtual Reality Training in Amblyopia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 14, 2022 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amblyopia
Keywords
amblyopia, virtual reality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Title
control group
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
visual function training software
Other Intervention Name(s)
visual function training software (model: SJ-JRS2021)
Intervention Description
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
Other
Intervention Name(s)
occlusion therapy
Intervention Description
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
Intervention Name(s)
corrective glasses
Intervention Description
corrective glasses
Primary Outcome Measure Information:
Title
Best corrected visual acuity
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Near stereopsis
Time Frame
16 weeks
Title
contrast sensitivity
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiajing Tang
Phone
+86 13732227517
Email
xiajingtang@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiajing Tang
Organizational Affiliation
Second Affiliated Hospital, School of Medicine, Zhejiang University
Official's Role
Study Chair
Facility Information:
Facility Name
The Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiajing Tang
Phone
+86 13732227517
Email
xiajingtang@zju.edu.cn

12. IPD Sharing Statement

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Effectiveness of Virtual Reality Training in Amblyopia

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