NCT06354309

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 9, 2024

Completed
Last Updated

June 3, 2025

Status Verified

June 1, 2025

Enrollment Period

3 months

First QC Date

April 3, 2024

Last Update Submit

June 1, 2025

Conditions

AmblyopiaMotion SicknessDry Eye

Keywords

Visual function trainingAmblyopiaVirtual realityMotion SicknessDry eye

Outcome Measures

Primary Outcomes (1)

  • Simulator Sickness Questionnaire Score

    Record the simulator sickness questionnaire score after use virtual reality game

    Baseline, 30min, 60min

Secondary Outcomes (9)

  • Postural stability

    Baseline, 30min, 60min

  • Non-invasive tear breakup time

    Baseline, 30min, 60min

  • Tear meniscus height

    Baseline, 30min, 60min

  • Lipid layer classification

    Baseline, 30min, 60min

  • Eye blink frequency

    Baseline, 30min, 60min

  • +4 more secondary outcomes

Study Arms (1)

Pre and post control study

EXPERIMENTAL

The subjects used the HMVR for 2 sessions of game training (30 minutes each, 10 minutes intervals).

Other: Virtual reality game

Interventions

Virtual reality gameOTHER

Pre and post control study after use virtual reality game

Pre and post control study

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age \>= 18
  • Best vision \>=1.0
  • Titmus is between 40s and 60s

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

He Eye Hospital

Shenyang, Liaoning, 110034, China

Location

MeSH Terms

Conditions

AmblyopiaMotion SicknessDry Eye Syndromes

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVision DisordersSensation DisordersNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsLacrimal Apparatus Diseases

Study Officials

  • Ling Xu, MD

    He Eye Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2024

First Posted

April 9, 2024

Study Start

August 1, 2023

Primary Completion

October 20, 2023

Study Completion

October 20, 2023

Last Updated

June 3, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)