AmblyopiaNCT06354309
Impact of Different Types of Virtual Reality Games on Motion Sickness and Ocular in Adults: A Pilot Study
A study testing Virtual reality game in people with Amblyopia and Motion Sickness, run by He Eye Hospital at 1 site in China.
Trial summary
The research project titled "The Impact of Immersive Virtual Reality Training on Adult: Motion Sickness, and Ocular Surface: A Pilot Study" aimed to evaluate the initial safety impact of head-mounted virtual reality (HMVR) devices with virtual reality amblyopia training games on postural stability, motion sickness… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Amblyopia, Motion Sickness, Dry Eye
- What is being tested?
- Virtual reality game
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 20 Oct 2023
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age >= 18
- Best vision >=1.0
- Titmus is between 40s and 60s
Who cannot join
- History of eye surgery and trauma within 3 months
- Active eye diseases
- Pregnancy and lactation period
- Allergic to fluorescein sodium
- The researcher determined that the subjects were not suitable for this study
Trial locations and contacts
1 site in 1 country.
About this study
The research project titled "The Impact of Immersive Virtual Reality Training on Adult: Motion Sickness, and Ocular Surface: A Pilot Study" aimed to evaluate the initial safety impact of head-mounted virtual reality (HMVR) devices with virtual reality amblyopia training games on postural stability, motion sickness, and ocular surface in healthy adult participants. 38 adults (76 eyes) with normal corrected vision and stereo vision were recruited. All subjects used HMVR device for two consecutive training sessions (30 minutes each, 10 minutes intervals). Before training, after the first training and the second training, recorded the results including best corrected visual acuity (BCVA), ocular position, stereo vision, postural stability, non-invasive tear breakup time (NITBUT), tear meniscus height (TMH), red eye analysis, lipid layer classification (TFLL), eye blink frequency, eye surface temperature, simulator sickness questionnaire (SSQ) score, ocular surface disease index (OSDI) dry eye questionnaire score, visual quality questionnaire score and visual fatigue questionnaire score.
Read the detailed description
- Title: The Impact of Immersive Virtual Reality Training on Adult: Motion Sickness, and Ocular Surface: A Pilot Study.
- Purpose: To evaluate the initial safety impact of head-mounted virtual reality (HMVR) devices with virtual reality amblyopia training games on postural stability, motion sickness, and ocular surface in healthy adult participants.
- Methods: A total of 38 healthy adult volunteers (18 males, 20 females) aged 18-42 years old were recruited from Shenyang He Eye Specialist Hospital from July to August 2023. Inclusion criteria: age ≥18 years; BCVA >=1.0; Titmus is between 40-60 ". Exclusion criteria: history of eye surgery and trauma within 3 months; Active eye problems; Pregnancy or lactation; Those who were determined by the investigator to be unsuitable for this study. This study was approved by the Ethics Committee of Shenyang He Eye Specialist Hospital (IRB(2023)K023.01).
3.1Research equipment Pico VR all-in-one (Neo2 Lite, Hainan Creative Vision Future Technology Co., LTD., China (referred to as "PICO") is a VR headset, which is used together with BeiShiYou visual function training software (BV-2, Shenyang BeiYou Technology Co., LTD., referred to as "BeiShiYou") 3.2 Procedure The procedure was divided into four steps: A. Sign the informed consent. B. First ophthalmic examination (diopter, BCVA, ocular position, stereo vision, postural stability, non-invasive tear breakup time, tear meniscus height, red eye analysis, lipid layer classification, eye blink frequency, eye surface temperature) and questionnaires survey (simulator sickness questionnaire, semans balance disorder scale, ocular surface disease index dry eye questionnaire, visual quality questionnaire and visual fatigue questionnaire). C. Conduct the first VR headset game training for 30 minutes, and then conduct the second eye examination and questionnaire survey above. D. Conduct the second VR headset game training for 30 minutes, and then conduct the third eye examination and questionnaire survey above (Figure 2).
3.3 Observation Indicators includes Simulator sickness questionnaire (SSQ), Postural stability, Non-invasive tear breakup time (NITBUT), Tear meniscus height, Lipid layer classification, Eye blink frequency, Central ocular surface temperature, Dry eye questionnaire score, Visual quality questionnaire score, Visual fatigue score.
- Conditions
- Amblyopia, Motion Sickness, Dry Eye
- Being tested
- Virtual reality game
- Keywords
- Visual function training, Amblyopia, Virtual reality, Motion Sickness, Dry eye
- Medical subject headings
- Amblyopia, Motion Sickness, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality gameOther
Pre and post control study after use virtual reality game
| Study group | Role | What they receive |
|---|---|---|
| Pre and post control study | Experimental | The subjects used the HMVR for 2 sessions of game training (30 minutes each, 10 minutes intervals). Receives: Other: Virtual reality game |
What is being measured
The primary outcome is the main question the study is designed to answer.
Simulator Sickness Questionnaire Score
Record the simulator sickness questionnaire score after use virtual reality game
Measured: Baseline, 30min, 60min
Secondary outcomes (9)
Postural stability
Record the postural stability level after use virtual reality game
Measured: Baseline, 30min, 60min
Non-invasive tear breakup time
Check with Eye Surface Analyzer (OCULUS, Germany)
Measured: Baseline, 30min, 60min
Tear meniscus height
Check with Eye Surface Analyzer (OCULUS, Germany)
Measured: Baseline, 30min, 60min
Lipid layer classification
Check with DR-1 dry eye measurement
Measured: Baseline, 30min, 60min
Eye blink frequency
Collect the blink frequency with DJI Pocket 2 Creator Combo (Shenzhen DJI Innovation Technology Co., LTD.)
Measured: Baseline, 30min, 60min
Eye surface temperature
Collect eye surface temperature with Flir ONE Pro mobile phone Infrared thermal camera for Apple IOS (Teledyne FLIR, USA)
Measured: Baseline, 30min, 60min
Ocular surface disease index dry eye questionnaire score
Record with OSDI questionaire
Measured: Baseline, 30min, 60min
Visual quality questionnaire score
Record with visual quality questionnaire
Measured: Baseline, 30min, 60min
Visual fatigue questionnaire score
Record with visual fatigue questionaire
Measured: Baseline, 30min, 60min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start1 Aug 2023
- Primary completion20 Oct 2023
- Study completion20 Oct 2023
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.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- He Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ling Xu, MD, Principal investigator, He Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06354309
- Sponsor's protocol ID
- VR_Study
- Status last verified
- Jun 2025
- First submitted
- 3 Apr 2024
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Different Types of Virtual Reality Games on Motion Sickness and Ocular in Adults: A Pilot Study
- ClinicalTrials.gov ID
- NCT06354309
- Acronym / sponsor ID
- VR_Study
- Conditions
- Amblyopia, Motion Sickness, Dry Eye
- Keywords
- Visual function training, Amblyopia, Virtual reality, Motion Sickness, Dry eye
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- He Eye HospitalUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 20 Oct 2023 (actual)
- Study completion
- 20 Oct 2023 (actual)
- First posted
- 9 Apr 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.
The research project titled "The Impact of Immersive Virtual Reality Training on Adult: Motion Sickness, and Ocular Surface: A Pilot Study" aimed to evaluate the initial safety impact of head-mounted virtual reality (HMVR) devices with virtual reality amblyopia training games on postural stability, motion sickness, and ocular surface in healthy adult participants. 38 adults (76 eyes) with normal corrected vision and stereo vision were recruited. All subjects used HMVR device for two consecutive training sessions (30 minutes each, 10 minutes intervals). Before training, after the first training and the second training, recorded the results including best corrected visual acuity (BCVA), ocular position, stereo vision, postural stability, non-invasive tear breakup time (NITBUT), tear meniscus height (TMH), red eye analysis, lipid layer classification (TFLL), eye blink frequency, eye surface temperature, simulator sickness questionnaire (SSQ) score, ocular surface disease index (OSDI) dry eye questionnaire score, visual quality questionnaire score and visual fatigue questionnaire score.
Detailed description
- Title: The Impact of Immersive Virtual Reality Training on Adult: Motion Sickness, and Ocular Surface: A Pilot Study.
- Purpose: To evaluate the initial safety impact of head-mounted virtual reality (HMVR) devices with virtual reality amblyopia training games on postural stability, motion sickness, and ocular surface in healthy adult participants.
- Methods: A total of 38 healthy adult volunteers (18 males, 20 females) aged 18-42 years old were recruited from Shenyang He Eye Specialist Hospital from July to August 2023. Inclusion criteria: age ≥18 years; BCVA >=1.0; Titmus is between 40-60 ". Exclusion criteria: history of eye surgery and trauma within 3 months; Active eye problems; Pregnancy or lactation; Those who were determined by the investigator to be unsuitable for this study. This study was approved by the Ethics Committee of Shenyang He Eye Specialist Hospital (IRB(2023)K023.01).
3.1Research equipment Pico VR all-in-one (Neo2 Lite, Hainan Creative Vision Future Technology Co., LTD., China (referred to as "PICO") is a VR headset, which is used together with BeiShiYou visual function training software (BV-2, Shenyang BeiYou Technology Co., LTD., referred to as "BeiShiYou") 3.2 Procedure The procedure was divided into four steps: A. Sign the informed consent. B. First ophthalmic examination (diopter, BCVA, ocular position, stereo vision, postural stability, non-invasive tear breakup time, tear meniscus height, red eye analysis, lipid layer classification, eye blink frequency, eye surface temperature) and questionnaires survey (simulator sickness questionnaire, semans balance disorder scale, ocular surface disease index dry eye questionnaire, visual quality questionnaire and visual fatigue questionnaire). C. Conduct the first VR headset game training for 30 minutes, and then conduct the second eye examination and questionnaire survey above. D. Conduct the second VR headset game training for 30 minutes, and then conduct the third eye examination and questionnaire survey above (Figure 2).
3.3 Observation Indicators includes Simulator sickness questionnaire (SSQ), Postural stability, Non-invasive tear breakup time (NITBUT), Tear meniscus height, Lipid layer classification, Eye blink frequency, Central ocular surface temperature, Dry eye questionnaire score, Visual quality questionnaire score, Visual fatigue score.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pre and post control study | Experimental | Other: Virtual reality gameThe subjects used the HMVR for 2 sessions of game training (30 minutes each, 10 minutes intervals). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age >= 18
- Best vision >=1.0
- Titmus is between 40s and 60s
Key exclusion criteria (5 listed)
- History of eye surgery and trauma within 3 months
- Active eye diseases
- Pregnancy and lactation period
- Allergic to fluorescein sodium
- The researcher determined that the subjects were not suitable for this 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 gamePre and post control study after use virtual reality game | Other | Pre and post control study |
Primary outcome
Simulator Sickness Questionnaire Score
Time frame: Baseline, 30min, 60min
Record the simulator sickness questionnaire score after use virtual reality game
9 secondary outcomes
Postural stability
Time frame: Baseline, 30min, 60min
Non-invasive tear breakup time
Time frame: Baseline, 30min, 60min
Tear meniscus height
Time frame: Baseline, 30min, 60min
Lipid layer classification
Time frame: Baseline, 30min, 60min
Eye blink frequency
Time frame: Baseline, 30min, 60min
Eye surface temperature
Time frame: Baseline, 30min, 60min
Ocular surface disease index dry eye questionnaire score
Time frame: Baseline, 30min, 60min
Visual quality questionnaire score
Time frame: Baseline, 30min, 60min
Visual fatigue questionnaire score
Time frame: Baseline, 30min, 60min
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 3 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Ling Xu, MD principal investigator
He Eye Hospital
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 game in people with Amblyopia and Motion Sickness, run by He Eye 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 3 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 3 Jun 2025. 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?
Simulator Sickness Questionnaire Score (time frame: Baseline, 30min, 60min). 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 3 Jun 2025.