Virtual Reality TherapyNCT07042022
Digital Defocus Vision Training (DDVT) System Development and Application
A study testing Development of digital defocus vision training (DDVT) in people with Virtual Reality Therapy, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 2 sites in China.
Trial summary
Myopia is the first major disease affecting the visual health of young children. With the increase in the use of electronic products and the decrease in the time for outdoor exercise, the incidence of myopia is increasing year by year. Smith et al. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality Therapy
- What is being tested?
- Development of digital defocus vision training (DDVT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 2 sitesChina
- Study dates
- 1 Oct 2024to 8 Oct 2025
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children aged 6 to 12 years
- diagnosis of myopia with SER of -0.75 to -6.00 D
- regular astigmatism, and astigmatism less than 2.50D
- anisometropia less than 1.50 D
- a logMAR best-corrected visual acuity (BCVA) of 0.00 or better
- an understanding by participants and their legal guardians of the purpose of the study
Who cannot join
- other myopia control therapies in the last 6 months (including but not limited to atropine and orthokeratology)
- strabismus, amblyopia, congenital lens dislocation, congenital cataract, glaucoma, uveitis, nystagmus, keratoconus, eye neoplasms and other ocular diseases
- systemic diseases such as nephrotic syndrome or diabetes
- structural changes in the eyeball, a history of ocular surgery or trauma
- other systemic diseases affecting eye health
- participants in other clinical trials at the same time.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing Ophthalmology and Visual Sciences Key Laboratory, Beijing Tongren Eye Center
Beijing, 100730
State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science, Sun Yat-Sen Universit
Guangzhou, Guangdong, 510060
About this study
Official title: Development of Digital Defocus Vision Training (DDVT) System Based on Virtual Reality Technology and Its Application in Myopia Regulation
Myopia is the first major disease affecting the visual health of young children. With the increase in the use of electronic products and the decrease in the time for outdoor exercise, the incidence of myopia is increasing year by year. Smith et al. firstly found that peripheral retinal defocus affects the course of myopia development in rhesus monkeys. Subsequent studies have shown that peripheral retinal hyperopic defocus can lead to the growth of the axial length (AL), leading to the development of myopia, while peripheral retinal myopic defocus can effectively slow down the growth of the AL, thus delaying the progression of myopia. Defocus signals can simultaneously change the thickness of the choroid, the vascular tissue behind the retina, and the pigment epithelium, and change the thickness and hardness of the sclera, inhibiting or promoting the growth of the axial length. Therefore, many methods have been designed to intervene in the development of myopia, including orthokeratology and peripheral defocusing glasses. The maintenance process of orthokeratology lens is complex and there is a risk of infection. Peripheral defocus glasses need to be worn for a long time, and the visual quality is unstable. It is still necessary to explore safer, more effective and more practical methods for myopia control. In addition, there may be some correlation between the development of myopia and the decrease of choroidal blood flow. Defocus signal may promote the increase of choroidal blood flow, which may be a way to prevent and control myopia.
Therefore, the investigators integrated the digital defocus paradigm into VR devices and developed a digital defocus vision training (DDVT) system. The purpose of this study was to investigate the effectiveness and safety of DDVT in the prevention and control of myopia in children.
- Conditions
- Virtual Reality Therapy
- Being tested
- Development of digital defocus vision training (DDVT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Development of digital defocus vision training (DDVT)Device
During a six-month follow-up period, participants received 10 minutes of DDVT twice a day (once in the morning, and the other in the afternoon) using a head-mounted VR display. In daily life during non-training sessions, participants were required to wear frame glasses with complete correction.
| Study group | Role | What they receive |
|---|---|---|
| DDVT training group | Experimental | During a six-month follow-up period, participants received 10 minutes of DDVT twice a day (once in the morning, and the other in the afternoon) using a head-mounted virtual reality (VR) display. In daily life during non-training sessions, participants were required to wear frame glasses with complete correction. Receives: Device: Development of digital defocus vision training (DDVT) |
| control group | No intervention | The control group did not have any myopia prevention and control intervention in half a year, and only wore complete-corrected frame glasses in daily life |
What is being measured
The primary outcome is the main question the study is designed to answer.
the axial length （AL）
The axial length of the eye is the distance from the anterior surface of the cornea to the posterior surface of the retina. In a normal adult, it is approximately 24 mm , and its growth is closely related to myopia . AL was measured using the IOL Master (Carl Zeiss 500, Meditec, Oberkochen, Germany)
Measured: 1 year
Secondary outcomes (1)
spherical equivalent refraction
Then used 0.5% tropicamide, five minutes apart, to perform three cycloplegia. The pupil is not considered fully dilated until it is larger than 6mm and/or has no light reflex. Autorefraction was measured in each eye using the Topcon KR-8800 (Topcon, Tokyo, Japan). Cycloplegic spherical equivalent refraction (SER) was defined as the spherical degree plus half of the cylindrical degree.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start1 Oct 2024
- Primary completion1 Oct 2025
- Study completion8 Oct 2025
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 Virtual Reality TherapyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Yuan, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07042022
- Sponsor's protocol ID
- 2023KYPJ282
- Status last verified
- Jun 2025
- First submitted
- 7 Jun 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhong J, Liu Y, Peng T, Ma J, Huang Z, Yang X, Li SM, Yuan J. Digital Defocus Vision Training Using Virtual Reality for Myopia Control: A Randomized Clinical Trial. JAMA Ophthalmol. 2026 Aug 27:e263490. doi: 10.1001/jamaophthalmol.2026.3490. Online ahead of print.
PubMed 42658516
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Digital Defocus Vision Training (DDVT) System Based on Virtual Reality Technology and Its Application in Myopia Regulation
- ClinicalTrials.gov ID
- NCT07042022
- Acronym / sponsor ID
- 2023KYPJ282
- Conditions
- Virtual Reality Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 8 Oct 2025 (actual)
- First posted
- 27 Jun 2025 (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.
Myopia is the first major disease affecting the visual health of young children. With the increase in the use of electronic products and the decrease in the time for outdoor exercise, the incidence of myopia is increasing year by year. Smith et al. firstly found that peripheral retinal defocus affects the course of myopia development in rhesus monkeys. Subsequent studies have shown that peripheral retinal hyperopic defocus can lead to the growth of the axial length (AL), leading to the development of myopia, while peripheral retinal myopic defocus can effectively slow down the growth of the AL, thus delaying the progression of myopia. Defocus signals can simultaneously change the thickness of the choroid, the vascular tissue behind the retina, and the pigment epithelium, and change the thickness and hardness of the sclera, inhibiting or promoting the growth of the axial length. Therefore, many methods have been designed to intervene in the development of myopia, including orthokeratology and peripheral defocusing glasses. The maintenance process of orthokeratology lens is complex and there is a risk of infection. Peripheral defocus glasses need to be worn for a long time, and the visual quality is unstable. It is still necessary to explore safer, more effective and more practical methods for myopia control. In addition, there may be some correlation between the development of myopia and the decrease of choroidal blood flow. Defocus signal may promote the increase of choroidal blood flow, which may be a way to prevent and control myopia.
Therefore, the investigators integrated the digital defocus paradigm into VR devices and developed a digital defocus vision training (DDVT) system. The purpose of this study was to investigate the effectiveness and safety of DDVT in the prevention and control of myopia in children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DDVT training group | Experimental | Device: Development of digital defocus vision training (DDVT)During a six-month follow-up period, participants received 10 minutes of DDVT twice a day (once in the morning, and the other in the afternoon) using a head-mounted virtual reality (VR) display. In daily life during non-training sessions, participants were required to wear frame glasses with complete correction. |
| control group | No intervention | –The control group did not have any myopia prevention and control intervention in half a year, and only wore complete-corrected frame glasses in daily life |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- children aged 6 to 12 years
- diagnosis of myopia with SER of -0.75 to -6.00 D
- regular astigmatism, and astigmatism less than 2.50D
- anisometropia less than 1.50 D
- a logMAR best-corrected visual acuity (BCVA) of 0.00 or better
Key exclusion criteria (6 listed)
- other myopia control therapies in the last 6 months (including but not limited to atropine and orthokeratology)
- strabismus, amblyopia, congenital lens dislocation, congenital cataract, glaucoma, uveitis, nystagmus, keratoconus, eye neoplasms and other ocular diseases
- systemic diseases such as nephrotic syndrome or diabetes
- structural changes in the eyeball, a history of ocular surgery or trauma
- other systemic diseases affecting eye health
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 |
|---|---|---|
| Development of digital defocus vision training (DDVT)During a six-month follow-up period, participants received 10 minutes of DDVT twice a day (once in the morning, and the other in the afternoon) using a head-mounted VR display. In daily life during non-training sessions, participants were required to wear frame glasses with complete correction. | Device | DDVT training group |
Primary outcome
the axial length （AL）
Time frame: 1 year
The axial length of the eye is the distance from the anterior surface of the cornea to the posterior surface of the retina. In a normal adult, it is approximately 24 mm , and its growth is closely related to myopia . AL was measured using the IOL Master (Carl Zeiss 500, Meditec, Oberkochen, Germany)
1 secondary outcome
spherical equivalent refraction
Time frame: 1 year
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 6 Jan 2026.
- Derived from this study: PubMed 42658516Zhong J, Liu Y, Peng T, Ma J, Huang Z, Yang X, Li SM, Yuan J. Digital Defocus Vision Training Using Virtual Reality for Myopia Control: A Randomized Clinical Trial. JAMA Ophthalmol. 2026 Aug 27:e263490. doi: 10.1001/jamaophthalmol.2026.3490. Online ahead of print.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Development of digital defocus vision training (DDVT) in people with Virtual Reality Therapy, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 2 sites 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 6 inclusion and 6 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 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
the axial length （AL） (time frame: 1 year). 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 NCT07042022, 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 6 Jan 2026.