MyopiaNCT03427697

Effect of VR and Accommdation Relax on Controlling Myopia in Children

A study testing Virtual reality and accommodation relax techniques in combination in people with Myopia and Accommodation Spasm, run by Beijing Tongren Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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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… Read more about this study

Who is it for?: Ages 6 to 9 years
Conditions the study is for: Myopia, Accommodation Spasm, Children
What is being tested?: Virtual reality and accommodation relax techniques in combination
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,000 participants
Where: 1 siteChina
Study dates: 18 Sep 2020to 31 Dec 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 9 years
All sexes
No healthy volunteers
Child

Who may be able to join

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;

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

Beijing Tongren Hospital
Beijing, Beijing Municipality, 100730

Other trials in China

About this study

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

Conditions: Myopia, Accommodation Spasm, Children
Being tested: Virtual reality and accommodation relax techniques in combination
Medical subject headings: Myopia, Spasm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Virtual reality and accommodation relax techniques in combinationDevice
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.

Study groups in NCT03427697
Study group	Role	What they receive
Intervention group	Experimental	Head-mounted video display which shows video with virtual reality and accommodation relax technique in combination,40 minutes per day Receives: Device: Virtual reality and accommodation relax techniques in combination
Control group	No intervention	No intervention will be performed in the control group

What is being measured

The primary outcome is the main question the study is designed to answer.

Myopia progression
The change in spherical equivalent
Measured: One year
Axial elongation
Chnage in axial length
Measured: 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)
Measured: One week and One month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Sep 202031 Dec 2022

First posted9 Feb 2018
Study start18 Sep 2020 (estimated)
Primary completion18 Dec 2022 (estimated)
Study completion31 Dec 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for MyopiaStudies of the same condition, open and under way.
More trials run by Beijing Tongren HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 1,000 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03427697
Sponsor's protocol ID: TRECKY20170704
Status last verified: Jul 2020
First submitted: 17 Dec 2017
Last updated: 8 Jul 2020
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
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BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
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Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Virtual Reality and Accommodation Relax Techniques in Combination on Controlling Myopia Development in School-aged Children
ClinicalTrials.gov ID: NCT03427697
Acronym / sponsor ID: TRECKY20170704
Conditions: Myopia, Accommodation Spasm, Children
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 1,000 participants (estimated)
Lead sponsor: Beijing Tongren HospitalUniversity, hospital or other
Study start: 18 Sep 2020 (estimated)
Primary completion: 18 Dec 2022 (estimated)
Study completion: 31 Dec 2022 (estimated)
First posted: 9 Feb 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Intervention group	Experimental	Device: Virtual reality and accommodation relax techniques in combinationHead-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

Who may qualify

Ages: 6 to 9 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

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;

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Virtual reality and accommodation relax techniques in combinationThe 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.	Device	Intervention group

Primary outcome

Myopia progression
Time frame: One year
The change in spherical equivalent
Axial elongation
Time frame: One year
Chnage in axial length

1 secondary outcome

Accommodative lag
Time frame: One week and One month

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.

Related trials for Myopia

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Virtual reality and accommodation relax techniques in combination in people with Myopia and Accommodation Spasm, run by Beijing Tongren Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Myopia progression (time frame: One year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03427697.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2020.