- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03427697
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
Status
Unknown
Conditions
Intervention / Treatment
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.
Sponsor
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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