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Effect of VR and Accommdation Relax on Controlling Myopia in Children

Primary Purpose

Myopia, Accommodation Spasm, Children

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Virtual reality and accommodation relax techniques in combination
Sponsored by
Beijing Tongren Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myopia

Eligibility Criteria

6 Years - 9 Years (Child)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Beijing Tongren Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

Head-mounted video display which shows video with virtual reality and accommodation relax technique in combination,40 minutes per day

No intervention will be performed in the control group

Outcomes

Primary Outcome Measures

Myopia progression
The change in spherical equivalent
Axial elongation
Chnage in axial length

Secondary Outcome Measures

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

Full Information

First Posted
December 17, 2017
Last Updated
July 7, 2020
Sponsor
Beijing Tongren Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03427697
Brief Title
Effect of VR and Accommdation Relax on Controlling Myopia in Children
Official Title
Effect of Virtual Reality and Accommodation Relax Techniques in Combination on Controlling Myopia Development in School-aged Children
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 18, 2020 (Anticipated)
Primary Completion Date
December 18, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tongren Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Accommodation Spasm, Children

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Head-mounted video display which shows video with virtual reality and accommodation relax technique in combination,40 minutes per day
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention will be performed in the control group
Intervention Type
Device
Intervention Name(s)
Virtual reality and accommodation relax techniques in combination
Intervention Description
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.
Primary Outcome Measure Information:
Title
Myopia progression
Description
The change in spherical equivalent
Time Frame
One year
Title
Axial elongation
Description
Chnage in axial length
Time Frame
One year
Secondary Outcome Measure Information:
Title
Accommodative lag
Description
Difference between accommodative demand and accommodative response measured by an open-field autorefractor (WAM-5500, Grand Seiko Co Ltd, Hiroshima, Japan)
Time Frame
One week and One month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
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;
Facility Information:
Facility Name
Beijing Tongren Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China

12. IPD Sharing Statement

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Effect of VR and Accommdation Relax on Controlling Myopia in Children

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