Zhejiang Adolescent Spine and Vision Health Cohort: A Longitudinal Database Analysis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-17
SponsorSecond Affiliated Hospital of Wenzhou Medical University
About this trial
The aim of study: 1. To investigate the prevalence of scoliosis, other spinal deformities, myopia, and visual impairments in adolescents (aged 6-18) in Zhejiang Province.
2.To track 8-year dynamic changes in spinal curvature and analyze associations between scoliosis, vision disorders, and potential risk factors.
3.To deliver scoliosis health education during screenings.
4.To mitigate scoliosis progression through early detection and intervention.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of idiopathic scoliosis at their first clinic visit
Skeletally immature (Risser Sign 0-3)
Cobb angle between 11-40 degrees
Age between 6 and 17
Disqualifiers
• Patients with scoliosis other than idiopathic, or with other musculoskeletal or neurodevelopmental conditions that might be responsible for the scoliosis
History of previous spine surgery or spinal injury
Tumor or malignant tumor in the spine
Leg length discrepancy more than 20 mm
Trial population
Adolescents participating in the Zhejiang Adolescent Spine and Vision Health Screening Program, China
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
73,000 Participants
are grouped into 2 trial groupsGroup A: IS with Myopia
Group B: IS without Myopia
Trial outcomes
Primary outcomes
1
Scoliosis Curve Angle
A long standard standing whole spine radiograph will be used for measuring curve size in terms of Cobb angle according to the standard Cobb method
Time frame
Baseline, 24 months (±1 month), and 48 months (±1 month) after enrollment; data will be analyzed through study completion, up to 96 months.]2
Angle of Trunk Rotation
In addition to spinal x-rays, a Scoliometer can also help monitor curve progression. The Scoliometer is an inclinometer that measures the asymmetries between the sides of the trunk by measuring axial rotation in degrees. Numerous studies have found a high correlation between trunk axial rotation (ATR) values and the Cobb angles.
Time frame
Baseline, 24 months (±1 month), and 48 months (±1 month) after enrollment; data will be analyzed through study completion, up to 96 months.]Secondary outcomes
1
Cycloplegic Mean Spherical Equivalent (MSE) for Myopia Diagnosis
MSE (diopters) will be calculated as \[sphere + ½ cylinder\] using autorefraction (Topcon KR-800) under cycloplegia (1% cyclopentolate). Myopia is defined as MSE ≤-0.50D. Triplicate measurements will be averaged per eye.
Time frame
Baseline and every 24 months (±1 month) until study completion, up to 96 months.2
Daily Near-Work Duration (UVD) Assessed by 30-Minute Block Questionnaire
Daily near-work activities (reading/digital screen use) will be recorded through the validated 20-item Near-Vision Activity Questionnaire (NVAQ). Total daily UVD will be calculated by summing 30-minute activity blocks (maximum 16 blocks/day).
Time frame
Baseline, 24 months (±1 month), and 48 months (±1 month) after enrollment; data will be analyzed through study completion, up to 96 months.3
Axial Length (AL) Growth Rate Measured by Swept-Source OCT
AL (mm) will be measured using swept-source optical coherence tomography (Topcon Triton Plus). Annualized growth rates (mm/year) will be calculated by linear regression of AL against time between baseline and each follow-up.
Time frame
Baseline, 24 months (±1 month), and 48 months (±1 month) after enrollment; data will be analyzed through study completion, up to 96 months.Sponsors and contacts
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Source ClinicalTrials.gov