Effect of VR and Accommdation Relax on Controlling Myopia in Children

July 7, 2020 updated by: Shi-Ming Li, Beijing Tongren Hospital

Effect of Virtual Reality and Accommodation Relax Techniques in Combination on Controlling Myopia Development in School-aged Children

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Beijing
      • Beijing, Beijing, China, 100730
        • Beijing Tongren Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 9 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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
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.
No Intervention: Control group
No intervention will be performed in the control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Myopia progression
Time Frame: One year
The change in spherical equivalent
One year
Axial elongation
Time Frame: One year
Chnage in axial length
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
One week and One month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 18, 2020

Primary Completion (Anticipated)

December 18, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

December 17, 2017

First Submitted That Met QC Criteria

February 3, 2018

First Posted (Actual)

February 9, 2018

Study Record Updates

Last Update Posted (Actual)

July 8, 2020

Last Update Submitted That Met QC Criteria

July 7, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRECKY20170704

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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