Effect of VR and Accommdation Relax on Controlling Myopia in Children

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

• Status: Unknown
• Conditions: Children; Myopia; Accommodation Spasm
• Intervention / Treatment: Device: Virtual reality and accommodation relax techniques in combination

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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.
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	The change in spherical equivalent	One year
Axial elongation	Chnage in axial length	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accommodative lag	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

• Sponsor: Beijing Tongren Hospital

Study record dates

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: Eye Diseases; Refractive Errors; Myopia
• 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