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Status unknownNCT03427697Updated Jul 8, 2020

Effect of VR and Accommdation Relax on Controlling Myopia in Children

An interventional study of Virtual reality and accommodation relax techniques in combination in Myopia, Accommodation Spasm and Children, sponsored by Beijing Tongren Hospital. Status unknown at 1 site in China. Open to participants aged 6 Years to 9 Years. Per ClinicalTrials.gov, last updated 2020-07-08.

Sponsored by Beijing Tongren Hospital · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jul 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
1,000
Allocation
Randomized
Ages
6 Years to 9 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Myopia
  • Accommodation Spasm
  • Children

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03

In context

Myopia

1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 78 across 923 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

Beijing Tongren Hospital is the lead sponsor of 164 studies on the registry; 54 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 9 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Can not endure virtual reality video;
  • Can not cooperate with ocular examinations;
  • Receiving other interventions for controlling myopia;
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
1,000 participants (estimated)

Study arms

  • 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

  • No intervention
    Control group

    No intervention will be performed in the control group

Interventions

  • DeviceVirtual 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.

06

What researchers measure

Primary outcomes

  1. Myopia progression

    The change in spherical equivalent

    Time frame: One year

  2. Axial elongation

    Chnage in axial length

    Time frame: One year

Secondary outcomes

  1. Accommodative lag

    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

07

Study locations

1 site
  • Beijing Tongren Hospital
    Beijing, Beijing 100730, China
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2020; primary completion for Dec 2022, 27 months later.

Of 200 non-industry interventional studies with no phase under Myopia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 27 months is close to that.

Counting every sponsor, half of 434 studies reached it within 14 months; a quarter within 3 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 17, 2017
First posted
Feb 9, 2018
StartEst.
Sep 18, 2020
Primary completionEst.
Dec 18, 2022
CompletionEst.
Dec 31, 2022
Last update
Jul 8, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 8, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03427697
Lead sponsor
Beijing Tongren Hospital
Responsible party
Shi-Ming Li (Associate professor, Beijing Tongren Hospital) — Principal investigator
First posted
Feb 9, 2018
Start date
Sep 18, 2020 (estimated)
Primary completion
Dec 18, 2022 (estimated)
Completion
Dec 31, 2022 (estimated)
Last update
Jul 8, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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