Skip to main content
Clinical Trials/NCT06354309
NCT06354309
Completed
Not Applicable

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

He Eye Hospital1 site in 1 country38 target enrollmentAugust 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Amblyopia
Sponsor
He Eye Hospital
Enrollment
38
Locations
1
Primary Endpoint
Simulator Sickness Questionnaire Score
Status
Completed
Last Updated
11 months ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2023
End Date
October 20, 2023
Last Updated
11 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
He Eye Hospital
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Simulator Sickness Questionnaire Score

Time Frame: Baseline, 30min, 60min

Record the simulator sickness questionnaire score after use virtual reality game

Secondary Outcomes

  • Lipid layer classification(Baseline, 30min, 60min)
  • Eye surface temperature(Baseline, 30min, 60min)
  • Visual quality questionnaire score(Baseline, 30min, 60min)
  • Non-invasive tear breakup time(Baseline, 30min, 60min)
  • Eye blink frequency(Baseline, 30min, 60min)
  • Ocular surface disease index dry eye questionnaire score(Baseline, 30min, 60min)
  • Postural stability(Baseline, 30min, 60min)
  • Tear meniscus height(Baseline, 30min, 60min)
  • Visual fatigue questionnaire score(Baseline, 30min, 60min)

Study Sites (1)

Loading locations...

Similar Trials