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OpenTrials
Completed

NCT Number: NCT06354309

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

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

He Eye Hospital

Shenyang, Liaoning, 110034, China

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

virtual reality game

Other

Pre and post control study after use virtual reality game

Primary outcomes

  1. Simulator Sickness Questionnaire Score

    Time frame: Baseline, 30min, 60min

    Record the simulator sickness questionnaire score after use virtual reality game

Secondary outcomes

  1. Postural stability

    Time frame: Baseline, 30min, 60min

    Record the postural stability level after use virtual reality game

  2. Non-invasive tear breakup time

    Time frame: Baseline, 30min, 60min

    Check with Eye Surface Analyzer (OCULUS, Germany)

  3. Tear meniscus height

    Time frame: Baseline, 30min, 60min

    Check with Eye Surface Analyzer (OCULUS, Germany)

  4. Lipid layer classification

    Time frame: Baseline, 30min, 60min

    Check with DR-1 dry eye measurement

  5. Eye blink frequency

    Time frame: Baseline, 30min, 60min

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

  6. Eye surface temperature

    Time frame: Baseline, 30min, 60min

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

  7. Ocular surface disease index dry eye questionnaire score

    Time frame: Baseline, 30min, 60min

    Record with OSDI questionaire

  8. Visual quality questionnaire score

    Time frame: Baseline, 30min, 60min

    Record with visual quality questionnaire

  9. Visual fatigue questionnaire score

    Time frame: Baseline, 30min, 60min

    Record with visual fatigue questionaire

Sponsors and collaborators

Lead sponsor

He Eye Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 9, 2024
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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