Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06354309 |
| Other study ID # |
vr_study |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2023 |
| Est. completion date |
October 20, 2023 |
Study information
| Verified date |
April 2024 |
| Source |
He Eye Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
