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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03427697
Other study ID # TRECKY20170704
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 18, 2020
Est. completion date December 31, 2022

Study information

Verified date July 2020
Source Beijing Tongren Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1000
Est. completion date December 31, 2022
Est. primary completion date December 18, 2022
Accepts healthy volunteers No
Gender All
Age group 6 Years to 9 Years
Eligibility 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 Design


Related Conditions & MeSH terms


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.

Locations

Country Name City State
China Beijing Tongren Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Beijing Tongren Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Myopia progression The change in spherical equivalent One year
Primary Axial elongation Chnage in axial length One year
Secondary 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
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