The Impact of Immersive Virtual Reality Training on Adult: Motion Sickness, and Ocular Surface: 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.

Study Overview

• Status: Completed
• Conditions: Dry Eye; Amblyopia; Motion Sickness
• Intervention / Treatment: Other: Virtual reality game

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.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110034
      • He Eye Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Pre and post control study after use virtual reality game

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Simulator Sickness Questionnaire Score	Record the simulator sickness questionnaire score after use virtual reality game	Baseline, 30min, 60min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postural stability	Record the postural stability level after use virtual reality game	Baseline, 30min, 60min
Non-invasive tear breakup time	Check with Eye Surface Analyzer (OCULUS, Germany)	Baseline, 30min, 60min
Tear meniscus height	Check with Eye Surface Analyzer (OCULUS, Germany)	Baseline, 30min, 60min
Lipid layer classification	Check with DR-1 dry eye measurement	Baseline, 30min, 60min
Eye blink frequency	Collect the blink frequency with DJI Pocket 2 Creator Combo (Shenzhen DJI Innovation Technology Co., LTD.)	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)	Baseline, 30min, 60min
Ocular surface disease index dry eye questionnaire score	Record with OSDI questionaire	Baseline, 30min, 60min
Visual quality questionnaire score	Record with visual quality questionnaire	Baseline, 30min, 60min
Visual fatigue questionnaire score	Record with visual fatigue questionaire	Baseline, 30min, 60min

Collaborators and Investigators

• Sponsor: He Eye Hospital
• Investigators: Principal Investigator: Ling Xu, MD, He Eye Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Actual): October 20, 2023
• Study Completion (Actual): October 20, 2023

Study Registration Dates

• First Submitted: April 3, 2024
• First Submitted That Met QC Criteria: April 8, 2024
• First Posted (Actual): April 9, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Virtual reality; Amblyopia; Dry eye; Motion Sickness; Visual function training
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Lacrimal Apparatus Diseases; Sensation Disorders; Vision Disorders; Dry Eye Syndromes; Amblyopia; Motion Sickness
• Other Study ID Numbers: vr_study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No