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Myopia Prevention Through Monitoring and Motivating Outdoor Activities With Smartwatches

Primary Purpose

Myopia, Progressive

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Outdoor activities motivation with smartwatches
Sponsored by
Shanghai Eye Disease Prevention and Treatment Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myopia, Progressive

Eligibility Criteria

4 Years - 9 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Outdoor activities motivating group

    Outdoor activities monitoring group

    Arm Description

    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.

    Outdoor activities are monitored with smartwatches.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    February 15, 2023
    Last Updated
    March 5, 2023
    Sponsor
    Shanghai Eye Disease Prevention and Treatment Center
    Collaborators
    Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05760911
    Brief Title
    Myopia Prevention Through Monitoring and Motivating Outdoor Activities With Smartwatches
    Official Title
    A Multi-center Clinical Study on the Myopia Prevention by Monitoring and Motivating Outdoor Activities With Smartwatches
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 15, 2023 (Anticipated)
    Primary Completion Date
    June 30, 2024 (Anticipated)
    Study Completion Date
    September 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shanghai Eye Disease Prevention and Treatment Center
    Collaborators
    Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myopia, Progressive

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Outdoor activities motivating group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Outdoor activities monitoring group
    Arm Type
    No Intervention
    Arm Description
    Outdoor activities are monitored with smartwatches.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Outdoor activities motivation with smartwatches
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    The change of spherical equivalent
    Description
    The mean change of spherical equivalent after cycloplegia was calculated during the study.
    Time Frame
    Two years
    Secondary Outcome Measure Information:
    Title
    The change of axial length
    Description
    The mean change of axial length by IOL Master was calculated during the study.
    Time Frame
    Two years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    9 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Haidong Zou, MD
    Phone
    02153555032
    Email
    zouhaidong@sjtu.edu.cn
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jun Chen, PhD
    Email
    chenjun_0809@163.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Myopia Prevention Through Monitoring and Motivating Outdoor Activities With Smartwatches

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