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CompletedNCT06354309Updated Jun 3, 2025

Impact of Different Types of Virtual Reality Games on Motion Sickness and Ocular in Adults: A Pilot Study

An interventional study of Virtual reality game in Amblyopia, Motion Sickness and Dry Eye, sponsored by He Eye Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-03.

Sponsored by He Eye Hospital · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Aug 2023, registered Apr 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
All
01

Study 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, 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
  1. Title: The Impact of Immersive Virtual Reality Training on Adult: Motion Sickness, and Ocular Surface: A Pilot Study.
  2. 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.
  3. 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.

02

Conditions studied

  • Amblyopia
  • Motion Sickness
  • Dry Eye

Keywords

  • Visual function training
  • Amblyopia
  • Virtual reality
  • Motion Sickness
  • Dry eye
03

In context

Amblyopia

189 studies on the registry are indexed under Amblyopia; 41 are open to participants now.

This study's enrollment of 38 is below the median of 60 across 137 interventional studies indexed under Amblyopia.

Browse Amblyopia studies →

Lead sponsor

He Eye Hospital is the lead sponsor of 31 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age >= 18
  • Best vision >=1.0
  • Titmus is between 40s and 60s

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
38 participants (actual)

Study arms

  • Experimental
    Pre and post control study

    The subjects used the HMVR for 2 sessions of game training (30 minutes each, 10 minutes intervals).

    Other: Virtual reality game

Interventions

  • OtherVirtual reality game

    Pre and post control study after use virtual reality game

06

What researchers measure

Primary outcomes

  1. Simulator Sickness Questionnaire Score

    Record the simulator sickness questionnaire score after use virtual reality game

    Time frame: Baseline, 30min, 60min

Secondary outcomes

  1. Postural stability

    Record the postural stability level after use virtual reality game

    Time frame: Baseline, 30min, 60min

  2. Non-invasive tear breakup time

    Check with Eye Surface Analyzer (OCULUS, Germany)

    Time frame: Baseline, 30min, 60min

  3. Tear meniscus height

    Check with Eye Surface Analyzer (OCULUS, Germany)

    Time frame: Baseline, 30min, 60min

  4. Lipid layer classification

    Check with DR-1 dry eye measurement

    Time frame: Baseline, 30min, 60min

  5. Eye blink frequency

    Collect the blink frequency with DJI Pocket 2 Creator Combo (Shenzhen DJI Innovation Technology Co., LTD.)

    Time frame: Baseline, 30min, 60min

  6. Eye surface temperature

    Collect eye surface temperature with Flir ONE Pro mobile phone Infrared thermal camera for Apple IOS (Teledyne FLIR, USA)

    Time frame: Baseline, 30min, 60min

  7. Ocular surface disease index dry eye questionnaire score

    Record with OSDI questionaire

    Time frame: Baseline, 30min, 60min

  8. Visual quality questionnaire score

    Record with visual quality questionnaire

    Time frame: Baseline, 30min, 60min

  9. Visual fatigue questionnaire score

    Record with visual fatigue questionaire

    Time frame: Baseline, 30min, 60min

07

Study locations

1 site
  • He Eye Hospital
    Shenyang, Liaoning 110034, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2023 to primary completion in Oct 2023, 2 months.

Of 58 non-industry interventional studies with no phase under Amblyopia, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 72. This study's 2 months is below that.

Counting every sponsor, half of 71 studies reached it within 33 months; a quarter within 17 and three quarters within 47.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 3, 2024
First posted
Apr 9, 2024
StartActual
Aug 1, 2023
Primary completionActual
Oct 20, 2023
CompletionActual
Oct 20, 2023
Last update
Jun 3, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06354309
Lead sponsor
He Eye Hospital
Responsible party
Sponsor
First posted
Apr 9, 2024
Start date
Aug 1, 2023
Primary completion
Oct 20, 2023
Completion
Oct 20, 2023
Last update
Jun 3, 2025

Study contacts

Ling Xu, MD
principal investigator · He Eye Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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