Myopia, ProgressiveNCT05760911
Myopia Prevention Through Monitoring and Motivating Outdoor Activities With Smartwatches
A study testing Outdoor activities motivation with smartwatches in people with Myopia, Progressive, run by Shanghai Eye Disease Prevention and Treatment Center.
Trial summary
The goal of this multi-center, randomized, parallel-controlled clinical trial is to evaluate the effectiveness of outdoor activities monitoring and motivating by smartwatches to prevent myopia progression in children. The main question it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 4 to 9 years
- Conditions the study is for
- Myopia, Progressive
- What is being tested?
- Outdoor activities motivation with smartwatches
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2023to 30 Sep 2024
- 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 4 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gender is not limited;
- Age: 4 ~ 9 years old;
- Spherical equivalent: -0.5D < SE < 2.5D;
- Be able to follow up for at least 2 years;
- Be able to wear a smartwatch on a daily basis as required;
- Parents or guardians sign an informed consent form;
- Children over 6 years old need oral consent to participate.
Who cannot join
- Anisometropia > 1.50D;
- Using other interventions for controlling myopia including atropine, rigid orthokeratology lenses, bifocal lenses or progressive lenses, red light, acupuncture, etc.;
- Strabismus and/or amblyopia;
- Previous history of eye surgery (including strabismus correction);
- Ocular or systemic diseases that may be related to the development of myopia or myopia: such as Marfan syndrome, neonatal retinopathy, diabetes, etc.;
- Other circumstances that the investigator judges inappropriate to participate in the trial.
Trial locations and contacts
No sites are listed yet.
Jun Chen, PhD contact
About this study
Official title: A Multi-center Clinical Study on the Myopia Prevention by Monitoring and Motivating Outdoor Activities With Smartwatches
The goal of this multi-center, randomized, parallel-controlled clinical trial is to evaluate the effectiveness of outdoor activities monitoring and motivating by smartwatches to prevent myopia progression in children. The main question it aims to answer are:
- To evaluate the two-year change of spherical equivalent progression.
- To evaluate the change in axial length, the incidence of myopia, the time of outdoor activity, the choroid thickness, and blood flow through the two-year intervention.
Participants will wear smartwatches and receive Mini Program outdoor activity reminders and motivations. The required outdoor activity time is 2 hours from Monday to Friday and more than 2 hours on weekends. The control group will only wear smartwatches for monitoring. Researchers will compare the control group and the intervention group to see if outdoor activities can protect myopia or not.
- Conditions
- Myopia, Progressive
- Being tested
- Outdoor activities motivation with smartwatches
- Medical subject headings
- Myopia, Degenerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outdoor activities motivation with smartwatchesBehavioural
Wearing a smartwatch and receiving outdoor activity reminders and encouragement through a mini-program. The required outdoor time is at least 2 hours from Monday to Friday, and more than 2 hours on weekends.
| Study group | Role | What they receive |
|---|---|---|
| Outdoor activities motivating group | Experimental | Wear a smartwatch and receive Mini Program reminders and encouragement for outdoor activities. The required outdoor time is at least 2 hours from Monday to Friday and more than 2 hours on weekends. Receives: Behavioral: Outdoor activities motivation with smartwatches |
| Outdoor activities monitoring group | No intervention | Outdoor activities are monitored with smartwatches. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of spherical equivalent
The mean change of spherical equivalent after cycloplegia was calculated during the study.
Measured: Two years
Secondary outcomes (1)
The change of axial length
The mean change of axial length by IOL Master was calculated during the study.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start15 Mar 2023 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myopia, ProgressiveStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05760911
- Sponsor's protocol ID
- kjb-wb-v1.1-20220507
- Status last verified
- Mar 2023
- First submitted
- 15 Feb 2023
- Last updated
- 9 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Clinical Study on the Myopia Prevention by Monitoring and Motivating Outdoor Activities With Smartwatches
- ClinicalTrials.gov ID
- NCT05760911
- Acronym / sponsor ID
- kjb-wb-v1.1-20220507
- Conditions
- Myopia, Progressive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Collaborators
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Study start
- 15 Mar 2023 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 9 Mar 2023 (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.
The goal of this multi-center, randomized, parallel-controlled clinical trial is to evaluate the effectiveness of outdoor activities monitoring and motivating by smartwatches to prevent myopia progression in children. The main question it aims to answer are:
- To evaluate the two-year change of spherical equivalent progression.
- To evaluate the change in axial length, the incidence of myopia, the time of outdoor activity, the choroid thickness, and blood flow through the two-year intervention.
Participants will wear smartwatches and receive Mini Program outdoor activity reminders and motivations. The required outdoor activity time is 2 hours from Monday to Friday and more than 2 hours on weekends. The control group will only wear smartwatches for monitoring. Researchers will compare the control group and the intervention group to see if outdoor activities can protect myopia or not.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Outdoor activities motivating group | Experimental | Behavioral: Outdoor activities motivation with smartwatchesWear a smartwatch and receive Mini Program reminders and encouragement for outdoor activities. The required outdoor time is at least 2 hours from Monday to Friday and more than 2 hours on weekends. |
| Outdoor activities monitoring group | No intervention | –Outdoor activities are monitored with smartwatches. |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Gender is not limited;
- Age: 4 ~ 9 years old;
- Spherical equivalent: -0.5D < SE < 2.5D;
- Be able to follow up for at least 2 years;
- Be able to wear a smartwatch on a daily basis as required;
Key exclusion criteria (6 listed)
- Anisometropia > 1.50D;
- Using other interventions for controlling myopia including atropine, rigid orthokeratology lenses, bifocal lenses or progressive lenses, red light, acupuncture, etc.;
- Strabismus and/or amblyopia;
- Previous history of eye surgery (including strabismus correction);
- Ocular or systemic diseases that may be related to the development of myopia or myopia: such as Marfan syndrome, neonatal retinopathy, diabetes, etc.;
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 |
|---|---|---|
| Outdoor activities motivation with smartwatchesWearing a smartwatch and receiving outdoor activity reminders and encouragement through a mini-program. The required outdoor time is at least 2 hours from Monday to Friday, and more than 2 hours on weekends. | Behavioural | Outdoor activities motivating group |
Primary outcome
The change of spherical equivalent
Time frame: Two years
The mean change of spherical equivalent after cycloplegia was calculated during the study.
1 secondary outcome
The change of axial length
Time frame: Two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Jun Chen, PhD contact
Questions about this trial
What is this clinical trial studying?
A study testing Outdoor activities motivation with smartwatches in people with Myopia, Progressive, run by Shanghai Eye Disease Prevention and Treatment Center.
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 7 inclusion and 6 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 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Haidong Zou, MD (02153555032, zouhaidong@sjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of spherical equivalent (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Mar 2023.