Myopia Prevention Through Monitoring and Motivating Outdoor Activities With Smartwatches

Shanghai Eye Disease Prevention and Treatment Center1,200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

1,200

Conditions

Myopia, Progressive

Interventions

Eligibility

Sex: ALLMin age: 4 YearsMax age: 9 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

The change of spherical equivalent

The mean change of spherical equivalent after cycloplegia was calculated during the study.

Time frame: Two years

Secondary Outcomes

The change of axial length

The mean change of axial length by IOL Master was calculated during the study.