Clinical trial NCT06992622: Zhejiang Adolescent Spine and Vision Health Cohort: A Longitudinal Database Analysis
Official title: Zhejiang Adolescent Spine and Vision Health Cohort: A Longitudinal Database Analysis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Scoliosis Idiopathic
Myopia
Vision Disorders
Keywords: Adolescent idiopathic scoliosis
Longitudinal progression
Spine-vision comorbidity
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2025-05-28
Enrollment: 73000
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents participating in the Zhejiang Adolescent Spine and Vision Health Screening Program, China

Brief summary: 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.

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

Primary outcomes:
measure: Scoliosis Curve Angle
timeFrame: Baseline, 24 months (±1 month), and 48 months (±1 month) after enrollment; data will be analyzed through study completion, up to 96 months.]
measure: Angle of Trunk Rotation
timeFrame: 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:
measure: Cycloplegic Mean Spherical Equivalent (MSE) for Myopia Diagnosis
timeFrame: Baseline and every 24 months (±1 month) until study completion, up to 96 months.
measure: Daily Near-Work Duration (UVD) Assessed by 30-Minute Block Questionnaire
timeFrame: Baseline, 24 months (±1 month), and 48 months (±1 month) after enrollment; data will be analyzed through study completion, up to 96 months.
measure: Axial Length (AL) Growth Rate Measured by Swept-Source OCT
timeFrame: Baseline, 24 months (±1 month), and 48 months (±1 month) after enrollment; data will be analyzed through study completion, up to 96 months.
Other outcomes:
Locations:
city: WenZhou
country: China
facility: The Second Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang 325000
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital of Wenzhou Medical University
name: Xiangyang Wang
role: STUDY_CHAIR
References: