Study on the Association of Time Pattern of Outdoor Activity With Axial Length and Myopia of Preschool Children and Its Intervention
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 210
- Primary Endpoint
- The changes in axial length (AL) and spherical equivalent (SE) compared to baseline after one year of intervention
Study Overview
Brief 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 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 4 Years to 5 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Intervention: Increase outdoor activity time during specific time periods.
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.
Intervention: Increase outdoor activity time during specific time periods (Behavioral)
continued their regular indoor or outdoor routine
The control group continued their regular indoor or outdoor routine.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- The incidence of myopia.(at baseline, at the 6th month of the intervention, and at the 12th month.)
Investigators
Fangbiao Tao
Professor
Anhui Medical University