Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06354309
Status:
COMPLETED
Last Update Posted:
2024-04-09
First Post:
2024-04-03
Brief Title:
The Impact of Immersive Virtual Reality Training on Adult Motion Sickness and Ocular Surface A Pilot Study
Sponsor:
He Eye Hospital
Organization:
He Eye Hospital
Study Overview
Official Title:
The Impact of Immersive Virtual Reality Training on Adult Motion Sickness and Ocular Surface A Pilot Study
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 10 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 IRB2023K02301
31Research 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 32 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
33 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
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 10 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 IRB2023K02301
31Research 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 32 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
33 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None