Impact of Different Types of Virtual Reality Games on Motion Sickness and Ocular in Adults: A Pilot Study
NCT ID: NCT06354309
Last Updated: 2025-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
38 participants
INTERVENTIONAL
2023-08-01
2023-10-20
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Pre and post control study
The subjects used the HMVR for 2 sessions of game training (30 minutes each, 10 minutes intervals).
Virtual reality game
Pre and post control study after use virtual reality game
Interventions
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Virtual reality game
Pre and post control study after use virtual reality game
Eligibility Criteria
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Inclusion Criteria
* Best vision \>=1.0
* Titmus is between 40s and 60s
Exclusion Criteria
* Active eye diseases
* Pregnancy and lactation period
* Allergic to fluorescein sodium
* The researcher determined that the subjects were not suitable for this study
18 Years
50 Years
ALL
Yes
Sponsors
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He Eye Hospital
OTHER
Responsible Party
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Principal Investigators
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Ling Xu, MD
Role: PRINCIPAL_INVESTIGATOR
He Eye Hospital
Locations
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He Eye Hospital
Shenyang, Liaoning, China
Countries
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Other Identifiers
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VR_Study
Identifier Type: -
Identifier Source: org_study_id
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