A Multi-center Clinical Study on the Myopia Prevention by Monitoring and Motivating Outdoor Activities With Smartwatches
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 1,200
- Primary Endpoint
- The change of spherical equivalent
Study Overview
Brief 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:
- 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 4 Years to 9 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Outdoor activities motivating group
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.
Intervention: Outdoor activities motivation with smartwatches (Behavioral)
Outdoor activities monitoring group
Outdoor activities are monitored with smartwatches.
Outcomes
Primary Outcomes
The change of spherical equivalent
Time Frame: Two years
The mean change of spherical equivalent after cycloplegia was calculated during the study.
Secondary Outcomes
- The change of axial length(Two years)