AmblyopiaNCT05732467
Effectiveness of Virtual Reality Training in Amblyopia
A study testing visual function training software, occlusion therapy and corrective glasses in people with Amblyopia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 7 years
- Conditions the study is for
- Amblyopia
- What is being tested?
- visual function training software, occlusion therapy and corrective glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 14 Nov 2022to 8 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
About this study
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.
- Conditions
- Amblyopia
- Being tested
- visual function training software, occlusion therapy, corrective glasses
- Keywords
- amblyopia, virtual reality
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
visual function training softwareDevice
Also called visual function training software (model: SJ-JRS2021)
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.
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.
corrective glassesOther
corrective glasses
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Not described Receives: Device: visual function training software; Other: corrective glasses |
| control group | Other | Not described Receives: Other: occlusion therapy; Other: corrective glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected visual acuity
Measured: 16 weeks
Secondary outcomes (2)
Near stereopsis
Measured: 16 weeks
contrast sensitivity
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start14 Nov 2022
- Primary completion8 Nov 2023
- Study completion8 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmblyopiaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiajing Tang, Study chair, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05732467
- Sponsor's protocol ID
- 2022-0755
- Status last verified
- Feb 2023
- First submitted
- 8 Feb 2023
- Last updated
- 1 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Virtual Reality Training in Amblyopia
- ClinicalTrials.gov ID
- NCT05732467
- Acronym / sponsor ID
- 2022-0755
- Conditions
- Amblyopia
- Keywords
- amblyopia, virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 8 Nov 2023 (actual)
- Study completion
- 8 Nov 2024 (actual)
- First posted
- 17 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Device: visual function training software, Other: corrective glasses |
| control group | Other | Other: occlusion therapy, Other: corrective glasses |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| visual function training softwareAlso: visual function training software (model: SJ-JRS2021)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. | Device | experimental group |
| occlusion therapyControl 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. | Other | control group |
| corrective glassescorrective glasses | Other | control group, experimental group |
Primary outcome
Best corrected visual acuity
Time frame: 16 weeks
2 secondary outcomes
Near stereopsis
Time frame: 16 weeks
contrast sensitivity
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiajing Tang study chair
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing visual function training software, occlusion therapy and corrective glasses in people with Amblyopia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best corrected visual acuity (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.