Clinical trial NCT06354309: Impact of Different Types of Virtual Reality Games on Motion Sickness and Ocular in Adults: A Pilot Study
Official title: Impact of Different Types of Virtual Reality Games on Motion Sickness and Ocular in Adults: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amblyopia
Motion Sickness
Dry Eye
Keywords: Visual function training
Amblyopia
Virtual reality
Motion Sickness
Dry eye
Lead sponsor: He Eye Hospital
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Simulator Sickness Questionnaire Score
timeFrame: Baseline, 30min, 60min
Secondary outcomes:
measure: Postural stability
timeFrame: Baseline, 30min, 60min
measure: Non-invasive tear breakup time
timeFrame: Baseline, 30min, 60min
measure: Tear meniscus height
timeFrame: Baseline, 30min, 60min
measure: Lipid layer classification
timeFrame: Baseline, 30min, 60min
measure: Eye blink frequency
timeFrame: Baseline, 30min, 60min
measure: Eye surface temperature
timeFrame: Baseline, 30min, 60min
measure: Ocular surface disease index dry eye questionnaire score
timeFrame: Baseline, 30min, 60min
measure: Visual quality questionnaire score
timeFrame: Baseline, 30min, 60min
measure: Visual fatigue questionnaire score
timeFrame: Baseline, 30min, 60min
Other outcomes:
Locations:
city: Shenyang
country: China
facility: He Eye Hospital
state: Liaoning
Study officials:
affiliation: He Eye Hospital
name: Ling Xu, MD
role: PRINCIPAL_INVESTIGATOR
References: