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

NCT06992622 | Recruiting DMC

• 1 other identifier: SAHoWMU-CR2025-08-220
• Study Type: observational
• Target: 73,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Scoliosis Idiopathic; Myopia; Vision Disorders

Keywords

Adolescent idiopathic scoliosis; Longitudinal progression; Spine-vision comorbidity

Outcome Measures

Primary Outcomes (2)

• 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

  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

  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.

  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 (3)

• Cycloplegic Mean Spherical Equivalent (MSE) for Myopia Diagnosis

  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

  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

  Baseline, 24 months (±1 month), and 48 months (±1 month) after enrollment; data will be analyzed through study completion, up to 96 months.

Study Arms (2)

IS with Myopia

diopathic scoliosis with untreated myopia

IS without Myopia

diopathic scoliosis without myopia

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Adolescents participating in the Zhejiang Adolescent Spine and Vision Health Screening Program, China

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang 325000

Wenzhou, Zhejiang, 325600, China

RECRUITING

MeSH Terms

Conditions

Myopia; Vision Disorders

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiangyang Wang

  Second Affiliated Hospital of Wenzhou Medical University

  STUDY CHAIR

Central Study Contacts

Xiangyang Wang

CONTACT

86-13506663458; Xiangyangwang@wmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Chief physician, Doctorial supervisor

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 28, 2025
• Study Start: September 30, 2024
• Primary Completion (Estimated): September 30, 2032
• Study Completion (Estimated): December 30, 2032
• Last Updated: May 28, 2025

Record last verified: 2025-05

Locations

CN (1)