Axial LengthNCT06607640
Study of the Intervention Effect of Outdoor Activity Period Patterns in Promoting Myopia Among Preschool Children
A study testing Increase outdoor activity time during specific time periods in people with Axial Length and Myopia, run by Fangbiao Tao.
Trial summary
This study is a randomized controlled trial based on outdoor activity interventions at specific time periods, involving preschool children aged 4 to 5 years. It compared the axial length and myopia incidence between the intervention group and the control group at the 6th and 12th months of the intervention to… Read more about this study
- Who is it for?
- Ages 4 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Axial Length, Myopia
- What is being tested?
- Increase outdoor activity time during specific time periods
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- No sites listed yet
- Study dates
- 21 Sep 2024to 21 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 4 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Students and their families were informed and voluntarily participated in the study, with parents signing the informed consent form.
- Able to cooperate with eye examinations and questionnaires.
Who cannot join
- Communication barriers, unable to cooperate.
- Strabismus, amblyopia, or any other ocular or systemic diseases that may affect refractive development.
- Children currently using orthokeratology lenses or rigid contact lenses.
- Using other interventions (such as acupuncture, massage, medication, ear acupuncture, etc.) to control myopia, apart from school eye exercises.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Study on the Association of Time Pattern of Outdoor Activity With Axial Length and Myopia of Preschool Children and Its Intervention
This study is a randomized controlled trial based on outdoor activity interventions at specific time periods, involving preschool children aged 4 to 5 years. It compared the axial length and myopia incidence between the intervention group and the control group at the 6th and 12th months of the intervention to determine the effect of outdoor activities at specific time periods on the prevention of myopia in preschool children. Additionally, the study investigated the association between outdoor activities at specific time periods and axial length and myopia in preschool children.
Read the detailed description
Preschool children with insufficient outdoor activity during specific time periods from one kindergarten were assigned to the intervention group, while those from another kindergarten with insufficient outdoor activity during specific time periods were assigned to the control group. The intervention group received an additional 1 hour of outdoor activity during a specific time period on each school day, while the control group did not receive any intervention and continued their regular routine. The intervention lasted for one year.
Participants underwent multiple assessments after joining the study. These assessments took place at baseline, at the 6th month of the intervention, and at the 12th month.
- Conditions
- Axial Length, Myopia
- Being tested
- Increase outdoor activity time during specific time periods
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Increase outdoor activity time during specific time periodsBehavioural
Also called Intervention with a specific outdoor activity model
The specific time periods of outdoor activity found to be beneficial for myopia prevention will be used as the intervention "target," and a one-year intervention will be initiated.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Increase outdoor activity time during specific time periods. | Experimental | The intervention group received an additional 1 hour of outdoor activity during a specific time period on each school day, with the intervention lasting for one year. Receives: Behavioral: Increase outdoor activity time during specific time periods |
| continued their regular indoor or outdoor routine | No intervention | The control group continued their regular indoor or outdoor routine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes in axial length (AL) and spherical equivalent (SE) compared to baseline after one year of intervention
The ocular physiological parameters, including axial length (AL), horizontal and vertical corneal curvature (K1 and K2), were measured using an optical biometer (model IOL Master 700). Each eye was measured three times, and if the difference between any two measurements exceeded 0.05 mm, the process was repeated until the difference was less than this value.An objective examination method was used under non-cycloplegic conditions (i.e., without pupil dilation), utilizing a tabletop automatic refractometer (ISO 10342-2010 Ophthalmic Instruments - Refractometers). The spherical equivalent (SE) was calculated as follows: SE = sphere power + 1/2 cylinder power.
Measured: at baseline, at the 6th month of the intervention, and at the 12th month.
Secondary outcomes (1)
The incidence of myopia.
The incidence of myopia is defined as the occurrence of myopia in children who were not myopic at baseline.
Measured: at baseline, at the 6th month of the intervention, and at the 12th month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start21 Sep 2024 (estimated)
- Primary completion21 Sep 2025 (estimated)
- Study completion21 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Axial LengthStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fangbiao Tao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fangbiao Tao, Anhui Medical University
- Investigators
- Yang Feng, Principal investigator, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06607640
- Sponsor's protocol ID
- 20240666
- Status last verified
- Sep 2024
- First submitted
- 19 Sep 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Association of Time Pattern of Outdoor Activity With Axial Length and Myopia of Preschool Children and Its Intervention
- ClinicalTrials.gov ID
- NCT06607640
- Acronym / sponsor ID
- 20240666
- Conditions
- Axial Length, Myopia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Fangbiao TaoUniversity, hospital or other
- Study start
- 21 Sep 2024 (estimated)
- Primary completion
- 21 Sep 2025 (estimated)
- Study completion
- 21 Dec 2025 (estimated)
- First posted
- 23 Sep 2024 (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 study is a randomized controlled trial based on outdoor activity interventions at specific time periods, involving preschool children aged 4 to 5 years. It compared the axial length and myopia incidence between the intervention group and the control group at the 6th and 12th months of the intervention to determine the effect of outdoor activities at specific time periods on the prevention of myopia in preschool children. Additionally, the study investigated the association between outdoor activities at specific time periods and axial length and myopia in preschool children.
Detailed description
Preschool children with insufficient outdoor activity during specific time periods from one kindergarten were assigned to the intervention group, while those from another kindergarten with insufficient outdoor activity during specific time periods were assigned to the control group. The intervention group received an additional 1 hour of outdoor activity during a specific time period on each school day, while the control group did not receive any intervention and continued their regular routine. The intervention lasted for one year.
Participants underwent multiple assessments after joining the study. These assessments took place at baseline, at the 6th month of the intervention, and at the 12th month.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention: Increase outdoor activity time during specific time periods. | Experimental | Behavioral: Increase outdoor activity time during specific time periodsThe intervention group received an additional 1 hour of outdoor activity during a specific time period on each school day, with the intervention lasting for one year. |
| continued their regular indoor or outdoor routine | No intervention | –The control group continued their regular indoor or outdoor routine. |
Who may qualify
- Ages
- 4 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Students and their families were informed and voluntarily participated in the study, with parents signing the informed consent form.
- Able to cooperate with eye examinations and questionnaires.
Key exclusion criteria (4 listed)
- Communication barriers, unable to cooperate.
- Strabismus, amblyopia, or any other ocular or systemic diseases that may affect refractive development.
- Children currently using orthokeratology lenses or rigid contact lenses.
- Using other interventions (such as acupuncture, massage, medication, ear acupuncture, etc.) to control myopia, apart from school eye exercises.
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 |
|---|---|---|
| Increase outdoor activity time during specific time periodsAlso: Intervention with a specific outdoor activity modelThe specific time periods of outdoor activity found to be beneficial for myopia prevention will be used as the intervention "target," and a one-year intervention will be initiated. | Behavioural | Intervention: Increase outdoor activity time during specific time periods. |
Primary outcome
The changes in axial length (AL) and spherical equivalent (SE) compared to baseline after one year of intervention
Time frame: at baseline, at the 6th month of the intervention, and at the 12th month.
The ocular physiological parameters, including axial length (AL), horizontal and vertical corneal curvature (K1 and K2), were measured using an optical biometer (model IOL Master 700). Each eye was measured three times, and if the difference between any two measurements exceeded 0.05 mm, the process was repeated until the difference was less than this value.An objective examination method was used under non-cycloplegic conditions (i.e., without pupil dilation), utilizing a tabletop automatic refractometer (ISO 10342-2010 Ophthalmic Instruments - Refractometers). The spherical equivalent (SE) was calculated as follows: SE = sphere power + 1/2 cylinder power.
1 secondary outcome
The incidence of myopia.
Time frame: at baseline, at the 6th month of the intervention, and at the 12th month.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
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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. This study is not recruiting at the moment.
Yang Feng principal investigator
Anhui Medical University
Questions about this trial
What is this clinical trial studying?
A study testing Increase outdoor activity time during specific time periods in people with Axial Length and Myopia, run by Fangbiao Tao.
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 2 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: status not confirmed, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tao Fang biao, professor (13856986775, taofangbiao@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes in axial length (AL) and spherical equivalent (SE) compared to baseline after one year of intervention (time frame: at baseline, at the 6th month of the intervention, and at the 12th month.). 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 23 Sep 2024.