School-based Myopia Prevention Trial for Children With Adequate Hyperopic Reserve

NCT07746752 | Recruiting

• 1 other identifier: KY2026-001-RE-011
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, school-based randomized controlled trial designed to evaluate a wearable device-supported outdoor activity program for myopia prevention in primary school students with adequate hyperopic reserve. Enrolled students in grades 1 to 4 will be randomly assigned to either a wearable device-supported outdoor activity program plus routine school-based eye health education or routine school-based eye health education alone. Outcomes will include changes in axial length and cycloplegic spherical equivalent refraction, incident myopia, intervention adherence, and safety outcomes over 12 months.

Conditions

Myopia; Hyperopia; Refractive Errors

Keywords

Myopia Prevention; Adequate Hyperopic Reserve; School-based Myopia Prevention; Outdoor Activity

Outcome Measures

Primary Outcomes (1)

• Change in Axial Length

  Change in axial length is defined as the difference between axial length measured at 12 months and axial length measured at baseline.

  Baseline to 12 months

Secondary Outcomes (4)

• Change in Cycloplegic Spherical Equivalent Refraction

  Baseline to 12 months

• Incidence of Myopia During Follow-up

  During the 12-month follow-up period

• Adherence to Wearable Device Use

  During the 12-month follow-up period

• Safety Outcomes and Adverse Events

  During the 12-month follow-up period

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants in the intervention group will receive a wearable device-supported outdoor activity program in addition to routine school-based eye health education during the 12-month study period.

Behavioral: Wearable Device-Supported Myopia Prevention Program; Behavioral: Eye Health Education

Control Group

ACTIVE COMPARATOR

Participants in the control group will receive routine school-based eye health education and maintain their usual daily activities during the 12-month study period. They will not receive structured outdoor activity targets, wearable device-supported outdoor activity monitoring, or reminders.

Behavioral: Eye Health Education

Interventions

Wearable Device-Supported Myopia Prevention Program BEHAVIORAL

The wearable device-supported program will use smart wearable wristbands to monitor outdoor activity time and provide reminders. Students in the intervention group will be encouraged to increase outdoor activity, with targets of at least 1 hour per day on school days and at least 2 hours per day on weekends. Data recorded by the wearable device will be used to quantify daily outdoor activity and assess adherence to the intervention.

Intervention Group

Eye Health Education BEHAVIORAL

Routine school-based eye health education will include general guidance on healthy visual behaviors, including reducing prolonged near work, maintaining appropriate reading posture and lighting conditions, performing standard eye exercises, and undergoing regular eye examinations.

Control Group; Intervention Group

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Students in grades 1 to 4 from participating schools.
• Non-myopic children with adequate hyperopic reserve at baseline, defined as cycloplegic spherical equivalent refraction in the worse eye within the following age-specific reference ranges: +1.72 D to +2.45 D at age 6 years; +1.48 D to +2.00 D at age 7 years; +1.19 D to +1.79 D at age 8 years; +1.11 D to +1.38 D at age 9 years; +0.92 D to +1.16 D at age 10 years; and +0.83 D to +1.07 D at age 11 years.
• Written informed consent provided by a parent or legal guardian, with assent obtained from the child when appropriate.

You may not qualify if:

• Strabismus, amblyopia, or other ocular abnormalities.
• Systemic disease or other medical conditions that may affect study participation.
• Has received any myopia prevention intervention in the past 3 months.
• Any other condition judged by the study doctors to make participation inappropriate.

Sponsors & Collaborators

• Shanghai Eye Disease Prevention and Treatment Center: lead

Study Sites (1)

Shanghai Eye Disease Prevention and Treatment Center

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Myopia; Refractive Errors; Hyperopia

Condition Hierarchy (Ancestors)

Eye Diseases

Central Study Contacts

Xiangui He, PhD

CONTACT

+86 021-62717733; xianhezi@163.com

Jingjing Wang, PhD

CONTACT

13011220912; 13011220912@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be stratified by grade within each participating school and randomly assigned in a 1:1 ratio to either the intervention group or the control group. For continuous outcomes, including changes in axial length and cycloplegic spherical equivalent refraction, mixed-effects models will be used to account for potential clustering within schools and grades. For binary outcomes, including incident myopia, good adherence to wearable device use, and adverse events, generalized estimating equations will be used as appropriate. Sensitivity analyses will be conducted to assess the robustness of the findings under different assumptions regarding clustering effects.

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 5, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)