MyopiaSPARKNCT07746752
School-based Myopia Prevention Trial for Children With Adequate Hyperopic Reserve
A study testing Wearable Device-Supported Myopia Prevention Program and Eye Health Education in people with Myopia and Refractive Errors, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Refractive Errors, Hyperopia
- What is being tested?
- Wearable Device-Supported Myopia Prevention Program and Eye Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Eye Disease Prevention and Treatment Center
Shanghai, Shanghai Municipality
Xiangui He, PhD, +86 021-62717733, xianhezi@163.com
Jingjing Wang, PhD, 13011220912, 13011220912@163.com
About this study
Official title: A Randomized Controlled Trial of a School-based Wearable Device-Supported Outdoor Activity Program for Myopia Prevention in Children With Adequate Hyperopic Reserve
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.
Read the detailed description
This prospective, school-based randomized controlled trial will be conducted among non-myopic children with adequate hyperopic reserve. Eligible participants are students in grades 1 to 4 from participating primary schools who meet the age-specific criteria for adequate hyperopic reserve based on cycloplegic spherical equivalent refraction in the worse eye and whose parents or legal guardians provide written informed consent.
Within each participating school, students will be stratified by grade and randomly assigned in a 1:1 ratio to the intervention group or the control group. The intervention group will receive routine school-based eye health education and wearable device-supported monitoring and reminders for outdoor activity. The control group will receive routine school-based eye health education and maintain usual daily activities without wearable device-supported outdoor activity monitoring or reminders.
Baseline and follow-up assessments will include ophthalmic examinations according to the study protocol. An interim follow-up assessment will also be conducted at 6 months, including visual acuity assessment, non-cycloplegic autorefraction, and axial length measurement. The primary outcome is the change in axial length from baseline to 12 months. Secondary outcomes include the change in cycloplegic spherical equivalent refraction, the incidence of myopia during follow-up, achievement of outdoor activity targets, adherence to wearable device use, and safety outcomes and adverse events.
- Conditions
- Myopia, Refractive Errors, Hyperopia
- Being tested
- Wearable Device-Supported Myopia Prevention Program, Eye Health Education
- Keywords
- Myopia Prevention, Adequate Hyperopic Reserve, School-based Myopia Prevention, Outdoor Activity
- Medical subject headings
- Myopia, Refractive Errors, Hyperopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable Device-Supported Myopia Prevention ProgramBehavioural
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.
Eye Health EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Eye Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 12 months
Secondary outcomes (4)
Change in Cycloplegic Spherical Equivalent Refraction
Change in cycloplegic spherical equivalent refraction is defined as the difference between the 12-month value and the baseline value.
Measured: Baseline to 12 months
Incidence of Myopia During Follow-up
Defined as the proportion of participants who develop myopia during follow-up, with myopia defined as uncorrected visual acuity less than 5.0 in either eye and non-cycloplegic spherical equivalent refraction less than -0.50 D in either eye.
Measured: During the 12-month follow-up period
Adherence to Wearable Device Use
Defined as adherence to wearing the study wearable device during the intervention period, as assessed using data recorded by the wearable device.
Measured: During the 12-month follow-up period
Safety Outcomes and Adverse Events
Defined as the occurrence of any adverse events related to wearable device use or increased outdoor activity, including skin irritation, device-related discomfort, eye discomfort related to sunlight exposure, or outdoor activity-related injuries.
Measured: During the 12-month follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start1 Jun 2026
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07746752
- Sponsor's protocol ID
- KY2026-001-RE-011
- Acronym
- SPARK
- Status last verified
- Apr 2026
- First submitted
- 31 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a School-based Wearable Device-Supported Outdoor Activity Program for Myopia Prevention in Children With Adequate Hyperopic Reserve
- ClinicalTrials.gov ID
- NCT07746752
- Acronym / sponsor ID
- SPARK / KY2026-001-RE-011
- Conditions
- Myopia, Refractive Errors, Hyperopia
- Keywords
- Myopia Prevention, Adequate Hyperopic Reserve, School-based Myopia Prevention, Outdoor Activity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This prospective, school-based randomized controlled trial will be conducted among non-myopic children with adequate hyperopic reserve. Eligible participants are students in grades 1 to 4 from participating primary schools who meet the age-specific criteria for adequate hyperopic reserve based on cycloplegic spherical equivalent refraction in the worse eye and whose parents or legal guardians provide written informed consent.
Within each participating school, students will be stratified by grade and randomly assigned in a 1:1 ratio to the intervention group or the control group. The intervention group will receive routine school-based eye health education and wearable device-supported monitoring and reminders for outdoor activity. The control group will receive routine school-based eye health education and maintain usual daily activities without wearable device-supported outdoor activity monitoring or reminders.
Baseline and follow-up assessments will include ophthalmic examinations according to the study protocol. An interim follow-up assessment will also be conducted at 6 months, including visual acuity assessment, non-cycloplegic autorefraction, and axial length measurement. The primary outcome is the change in axial length from baseline to 12 months. Secondary outcomes include the change in cycloplegic spherical equivalent refraction, the incidence of myopia during follow-up, achievement of outdoor activity targets, adherence to wearable device use, and safety outcomes and adverse events.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Wearable Device-Supported Myopia Prevention Program, Behavioral: Eye Health EducationParticipants 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. |
| Control Group | Active comparator | Behavioral: Eye Health EducationParticipants 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. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable Device-Supported Myopia Prevention ProgramThe 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. | Behavioural | Intervention Group |
| Eye Health EducationRoutine 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. | Behavioural | Control Group, Intervention Group |
Primary outcome
Change in Axial Length
Time frame: Baseline to 12 months
Change in axial length is defined as the difference between axial length measured at 12 months and axial length measured at baseline.
4 secondary outcomes
Change in Cycloplegic Spherical Equivalent Refraction
Time frame: Baseline to 12 months
Incidence of Myopia During Follow-up
Time frame: During the 12-month follow-up period
Adherence to Wearable Device Use
Time frame: During the 12-month follow-up period
Safety Outcomes and Adverse Events
Time frame: During the 12-month follow-up period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable Device-Supported Myopia Prevention Program and Eye Health Education in people with Myopia and Refractive Errors, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiangui He, PhD (+86 021-62717733, xianhezi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Axial Length (time frame: Baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.