Effect of VR and Accommdation Relax on Controlling Myopia in Children

NCT03427697 — Not applicable, Unknown, 1000 participants, Beijing Tongren Hospital

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

Registry	NCT03427697
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: triple, prevention
Enrollment	1000 (Estimated)
Sponsor	Beijing Tongren Hospital (Other)
Conditions	Myopia, Accommodation Spasm, Children
Interventions	Virtual reality and accommodation relax techniques in combination (Device)
Dates	start 2020-09-18 (estimated), primary completion 2022-12-18 (estimated), completion 2022-12-31 (estimated), first posted 2018-02-09, last updated 2020-07-08
Locations	1 site in China

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Intervention group	Experimental	Device: Virtual reality and accommodation relax techniques in combination	Head-mounted video display which shows video with virtual reality and accommodation relax technique in combination,40 minutes per day
Control group	No intervention		No intervention will be performed in the control group

Virtual reality and accommodation relax techniques in combination (Device): 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.

+Outcome measures

Primary outcomes

Myopia progression [One year]: The change in spherical equivalent
Axial elongation [One year]: Chnage in axial length

Secondary outcomes

Accommodative lag [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)

+Eligibility

Sex: All, ages: 6 Years to 9 Years

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;

+Locations (1)

Facility	City	Country	Status
Beijing Tongren Hospital	Beijing, Beijing Municipality	China

My Notes

Public

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