Myopia Prevention Through Monitoring and Motivating Outdoor Activities With Smartwatches

Not Applicable

Not yet recruiting

• Conditions: Myopia, Progressive
• Interventions: Behavioral: Outdoor activities motivation with smartwatches

• Registration Number: NCT05760911
• Lead Sponsor: Shanghai Eye Disease Prevention and Treatment Center

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:

1. To evaluate the two-year change of spherical equivalent progression.

2. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-15
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-05
• Last Update Submitted: 2023-03-05
• Study First Posted: 2023-03-09
• Last Update Posted: 2023-03-09
• Study Start: 2023-03-15
• Primary Completion: 2024-06-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

1. Gender is not limited;
2. Age: 4 ~ 9 years old;
3. Spherical equivalent: -0.5D < SE < 2.5D;
4. Be able to follow up for at least 2 years;
5. Be able to wear a smartwatch on a daily basis as required;
6. Parents or guardians sign an informed consent form;
7. Children over 6 years old need oral consent to participate.

Exclusion Criteria

1. Anisometropia > 1.50D;
2. Using other interventions for controlling myopia including atropine, rigid orthokeratology lenses, bifocal lenses or progressive lenses, red light, acupuncture, etc.;
3. Strabismus and/or amblyopia;
4. Previous history of eye surgery (including strabismus correction);
5. Ocular or systemic diseases that may be related to the development of myopia or myopia: such as Marfan syndrome, neonatal retinopathy, diabetes, etc.;
6. Other circumstances that the investigator judges inappropriate to participate in the trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Outdoor activities motivating group	Outdoor activities motivation with smartwatches	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.

Primary Outcome Measures

Name	Time	Method
The change of spherical equivalent	Two years	The mean change of spherical equivalent after cycloplegia was calculated during the study.

Secondary Outcome Measures

Name	Time	Method
The change of axial length	Two years	The mean change of axial length by IOL Master was calculated during the study.