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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2023-10-20

Brief Summary

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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

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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.

Conditions

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Amblyopia Motion Sickness Dry Eye

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

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).

Group Type EXPERIMENTAL

Virtual reality game

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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He Eye Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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China

Other Identifiers

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VR_Study

Identifier Type: -

Identifier Source: org_study_id

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