MyopiaNCT06250920
Effect of Virtual Reality-Based Visual Training for Myopia Control in Children
A study testing Virtual reality visual training in people with Myopia and Myopia, Progressive, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
To assess the efficacy and safety of virtual reality-based visual training (VRVT) in myopia control among children. Read more about this study
- Who is it for?
- Ages 8 to 13 years
- Conditions the study is for
- Myopia, Myopia, Progressive
- What is being tested?
- Virtual reality visual training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 30 Aug 2021
- 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 8 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 8-13 years old (inclusive), regardless of gender;
- The spherical equivalent of both eyes after cycloplegia was -3.00D to -0.50D (including);
- Binocular astigmatism ≤3.00D during screening;
- Anisometropia (according to spherical equivalent) ≤1.50D during screening;
- The intraocular pressure of any eye during screening was ≤21mmHg;
- At the time of screening, the best corrected distance visual acuity of any eye was ≥1.0 or LogMAR≤0;
- Good binocular stereopsis and stereopsis acuity ≤60 ";
- The subjects and their legal guardians were willing to participate in the study and signed written informed consent.
Who cannot join
- Existing or previous history of ophthalmic organic diseases, ophthalmic surgery, and obvious strabismus after wearing glasses;
- Using orthokeratology lenses, feeding instrument and other myopia prevention and control methods that may affect the study in the past 6 months;
- Subjects with poor vestibular function such as motion sickness and seasickness;
- Any history of diseases or syndromes that may cause severe myopia (e.g., Marfan syndrome, Stickler syndrome, retinopathy of prematurity, etc.); 5, any eye refractive media abnormalities (such as cornea, lens abnormalities, etc.);
- 6. Long-term use (i.e., more than 7 consecutive days in 1 month or more than 30 days in total in 1 year) of any local or systemic use of anticholinergic/anticholinergic drugs (e.g., atropine, scopolamine, tolacamide, etc.) within 21 days before screening and during the expected period of the study, allowing the use of cycloplegic drops for optometry and other examinations; 7. Severe systemic disease considered by the investigator as not suitable for the study; 8. Participation in other clinical trials within 30 days before screening; 9. Only one eye met the inclusion criteria; 10. Poor compliance, unable to go to medical institutions for treatment on a timely and regular basis as required; 11. Any other circumstances deemed inappropriate by the investigator to participate in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 270002
About this study
Official title: Effect of Virtual Reality-Based Visual Training for Myopia Control in Children: a Randomized Controlled Trial
To assess the efficacy and safety of virtual reality-based visual training (VRVT) in myopia control among children.
- Conditions
- Myopia, Myopia, Progressive
- Being tested
- Virtual reality visual training
- Medical subject headings
- Myopia, Myopia, Degenerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality visual trainingDevice
Children in intervention group were administered at home under the supervision of parents for 20 minutes per session every day with virtual reality visual training
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality-based visual training group | Experimental | Not described Receives: Device: Virtual reality visual training |
| Single-Vision Spectacle Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in axial length
Measured: baseline and the 3-month follow-up visits
Secondary outcomes (1)
changes in subfoveal choroidal thickness
Measured: baseline and the 3-month follow-up visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start1 Dec 2020
- Primary completion30 Aug 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies of the same condition, open and under way.
- 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
- Care provider, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing Yu, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06250920
- Sponsor's protocol ID
- 4.1/20-260/01
- Status last verified
- Feb 2024
- First submitted
- 1 Feb 2024
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xu Z, Zou A, Li L, Wu Y, Cai W, Ma J, Yu J. Effect of virtual reality-based visual training for myopia control in children: a randomized controlled trial. BMC Ophthalmol. 2024 Sep 16;24(1):358. doi: 10.1186/s12886-024-03580-w.
PubMed 39278928
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality-Based Visual Training for Myopia Control in Children: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06250920
- Acronym / sponsor ID
- 4.1/20-260/01
- Conditions
- Myopia, Myopia, Progressive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 9 Feb 2024 (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.
To assess the efficacy and safety of virtual reality-based visual training (VRVT) in myopia control among children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality-based visual training group | Experimental | Device: Virtual reality visual training |
| Single-Vision Spectacle Group | No intervention | – |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Age 8-13 years old (inclusive), regardless of gender;
- The spherical equivalent of both eyes after cycloplegia was -3.00D to -0.50D (including);
- Binocular astigmatism ≤3.00D during screening;
- Anisometropia (according to spherical equivalent) ≤1.50D during screening;
- The intraocular pressure of any eye during screening was ≤21mmHg;
Key exclusion criteria (5 listed)
- Existing or previous history of ophthalmic organic diseases, ophthalmic surgery, and obvious strabismus after wearing glasses;
- Using orthokeratology lenses, feeding instrument and other myopia prevention and control methods that may affect the study in the past 6 months;
- Subjects with poor vestibular function such as motion sickness and seasickness;
- Any history of diseases or syndromes that may cause severe myopia (e.g., Marfan syndrome, Stickler syndrome, retinopathy of prematurity, etc.); 5, any eye refractive media abnormalities (such as cornea, lens abnormalities, etc.);
- 6. Long-term use (i.e., more than 7 consecutive days in 1 month or more than 30 days in total in 1 year) of any local or systemic use of anticholinergic/anticholinergic drugs (e.g., atropine, scopolamine, tolacamide, etc.) within 21 days before screening and during the expected period of the study, allowing the use of cycloplegic drops for optometry and other examinations; 7. Severe systemic disease considered by the investigator as not suitable for the study; 8. Participation in other clinical trials within 30 days before screening; 9. Only one eye met the inclusion criteria; 10. Poor compliance, unable to go to medical institutions for treatment on a timely and regular basis as required; 11. Any other circumstances deemed inappropriate by the investigator to participate in the study.
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 |
|---|---|---|
| Virtual reality visual trainingChildren in intervention group were administered at home under the supervision of parents for 20 minutes per session every day with virtual reality visual training | Device | Virtual reality-based visual training group |
Primary outcome
changes in axial length
Time frame: baseline and the 3-month follow-up visits
1 secondary outcome
changes in subfoveal choroidal thickness
Time frame: baseline and the 3-month follow-up visits.
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 9 Feb 2024.
- Derived from this study: PubMed 39278928Xu Z, Zou A, Li L, Wu Y, Cai W, Ma J, Yu J. Effect of virtual reality-based visual training for myopia control in children: a randomized controlled trial. BMC Ophthalmol. 2024 Sep 16;24(1):358. doi: 10.1186/s12886-024-03580-w.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality visual training in people with Myopia and Myopia, Progressive, run by Shanghai 10th People's Hospital 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 8 inclusion and 5 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 9 Feb 2024. 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?
changes in axial length (time frame: baseline and the 3-month follow-up visits). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06250920, which also lists 1 linked publication.
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 9 Feb 2024.