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Recruiting NCT06992622

Zhejiang Adolescent Spine and Vision Health Cohort: A Longitudinal Database Analysis

Observational Scoliosis Idiopathic Myopia Vision Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Scoliosis Idiopathic, Myopia, Vision Disorders. Basic parameters: 6 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Detailed description

Scoliosis is the most common pediatric musculoskeletal disorder, affecting up to 4% of otherwise healthy children worldwide. Approximately 80-90% of cases are idiopathic scoliosis (IS), predominantly emerging during adolescence. While mild IS often causes no symptoms, moderate cases may lead to spinal deformity and mild respiratory dysfunction, with severe cases potentially resulting in cardiopulmonary compromise or even paralysis.

Despite extensive research exploring potential causes - including genetic, neuroendocrine, skeletal, muscular, postural, biomechanical and lifestyle factors - the underlying mechanisms of IS remain unclear. Bracing currently stands as the only proven conservative treatment to slow progression, yet 20-30% of braced patients still require eventual surgical correction. Adolescence represents both a critical window for rapid curve progression and the optimal period for effective intervention. Early screening has been demonstrated to significantly improve outcomes, highlighting the importance of preventive strategies during this developmental stage.

Recent studies across various populations have reported scoliosis prevalence rates ranging from 0.27% to 3.5%, with notable regional variations:

Singaporean studies found rates between 0.27%-2.49%

Greek research reported 1.7% prevalence

Large-scale US screening showed 0.9% prevalence

Chinese studies documented rates from 1.07% (Guangzhou) to 3.5% (Hong Kong)

Most existing research has been cross-sectional in design, lacking prospective data on curve progression patterns and associated risk factors.

This prospective cohort study aims to: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.

Primary outcome measures

  • Scoliosis Curve Angle [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.]]
  • Angle of Trunk Rotation [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 outcome measures (3)
  • Cycloplegic Mean Spherical Equivalent (MSE) for Myopia Diagnosis [Time frame: Baseline and every 24 months (±1 month) until study completion, up to 96 months.]
  • Daily Near-Work Duration (UVD) Assessed by 30-Minute Block Questionnaire [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.]
  • Axial Length (AL) Growth Rate Measured by Swept-Source OCT [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.]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • • 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
  • Previous diagnosis or treatment of SDB more than 6 months ago
  • Plans to relocate within the next 24 months

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • The Second Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang 325000 — Wenzhou

Identifiers

NCT: NCT06992622 · SAHoWMU-CR2025-08-220

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗