Effect of VR and Accommdation Relax on Controlling Myopia in Children

ID: NCT03427697
Status: Not yet recruiting
Phase: N/A
Start Date: April 18, 2018
First Submitted: December 17, 2017
Last Updated: February 23, 2018
Results: N/A
Sponsors & Collaborators: Beijing Tongren Hospital
Location: China
Conditions: Myopia, Accommodation Spasm, Children
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Study Description

Brief Summary

This study evaluates the effect of virtual reality and accommodation relax technique on controlling onset and development of myopia in school-aged children. Half of the children will receive head-mounted video display which shows video with virtual reality and accommodation relax technique in combination, while the other half will receive no intervention.

Detailed Description

Condition or disease Intervention/treatment Phase

Accommodation Spasm

Children

Myopia

Device: Virtual reality and accommodation relax techniques in combination
Other Names
N/A

Tracking Information

First Submitted DateDecember 17, 2017
Last Update Posted DateFebruary 23, 2018
Anticipated Start DateApril 18, 2018
Anticipated Completion DateSeptember 18, 2020
Anticipated Primary Completion DateMay 18, 2020
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Axial elongation [Time Frame: One year]

    Chnage in axial length

  • Myopia progression [Time Frame: One year]

    The change in spherical equivalent

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Accommodative lag [Time Frame: One week and One month]

    Difference between accommodative demand and accommodative response measured by an open-field autorefractor (WAM-5500, Grand Seiko Co Ltd, Hiroshima, Japan)

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleEffect of VR and Accommdation Relax on Controlling Myopia in Children
Official TitleEffect of Virtual Reality and Accommodation Relax Techniques in Combination on Controlling Myopia Development in School-aged Children
Brief Summary

This study evaluates the effect of virtual reality and accommodation relax technique on controlling onset and development of myopia in school-aged children. Half of the children will receive head-mounted video display which shows video with virtual reality and accommodation relax technique in combination, while the other half will receive no intervention.

Detailed Description

Study TypeInterventional
Study PhaseN/A
Estimated Enrollment
1000
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Triple
Primary Purpose
Prevention
Conditions
Accommodation Spasm
Children
Myopia
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Device: Virtual reality and accommodation relax techniques in combination

The children will be given head-mounted video display to watch video at break of classes, 40 minutes per day in total. The video will be shown by virtual reality and accommodation relax techniques in combination.

Other Names
Study Groups/Cohorts
Intervention group
Head-mounted video display which shows video with virtual reality and accommodation relax technique in combination,40 minutes per day

Control group
No intervention will be performed in the control group

Study Arms
Experimental Intervention group
Head-mounted video display which shows video with virtual reality and accommodation relax technique in combination,40 minutes per day
Device : Virtual reality and accommodation relax techniques in combination
The children will be given head-mounted video display to watch video at break of classes, 40 minutes per day in total. The video will be shown by virtual reality and accommodation relax techniques in combination.

Arm Intervention/Treatment
Experimental Intervention group
Head-mounted video display which shows video with virtual reality and accommodation relax technique in combination,40 minutes per day
Device : Virtual reality and accommodation relax techniques in combination

Recruitment Information

Recruitment Status:Not yet recruiting
Enrollment1000
Completion DateSeptember 18, 2020
Eligibility Criteria: Inclusion Criteria:
- Best corrected visual acuity >=20/20 for each eye;
- Astigmastism less than 1.5 D;
- Anisometropia less than 1.0D;
- No other ocular or systematic diseases;

Exclusion Criteria:
- Can not endure virtual reality video;
- Can not cooperate with ocular examinations;
- Receiving other interventions for controlling myopia;
GenderAll
Age6 Years to 9 Years
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
China

Administrative Information

NCT Number:NCT03427697
Other Study ID Numbers
TRECKY20170704
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible PartyShi-Ming Li, Beijing Tongren Hospital
Study Sponsor
Beijing Tongren Hospital
Collaborators
Not Available
Investigators
Not Available