China Axial Length Study | NCT05770661

Studies
China Axial Length Study

NCT05770661

Sponsor

Shanghai Eye Disease Prevention and Treatment Center

Status

Recruiting

Last Update Posted

Dec 18, 2025Actual

Enrollment

30,000Estimated

Phase

Not provided

Conditions

Axial Length
Myopia
Child Development

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 10, 2023Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Mar 5, 2023

First Submission Date that Met QC Criteria

Mar 5, 2023

First Posted Date

Mar 15, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 11, 2025

Last Update Posted Date

Dec 18, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jiannan Huang, Doctor, Shanghai Eye Disease Prevention and Treatment CenterPrincipal Investigator

Lead Sponsor

Shanghai Eye Disease Prevention and Treatment CenterOTHER

Collaborators

Name	Class
Tongji Hospital	OTHER
Sichuan Provincial People's Hospital	OTHER
Shandong University of Traditional Chinese Medicine	OTHER
People's Hospital of Ningxia Hui Autonomous Region

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The primary objective of this multi-center, observational study is to establish the reference ranges of axial length in Chinese children and adolescents.

30,000 children aged 3-18 years were examined with cycloplegia to collect their ocular parameters and were all followed up for three years with annual visits.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Myopes		To collect the ocular data among myopic children.
Non-myopes		To collect the ocular data among non-myopic children.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Axial length	Axial length in millimeter was examined by IOL Master	2023-2026

Secondary Outcomes

Measure	Description	Time Frame
Axial length elongation	The elongation in millimeter was the difference between two annual visits.	2023-2026

Other Outcomes

Measure	Description	Time Frame
Comparison of visual acuity outcomes obtained by VA charts with different optotypes among children	This outcome measure evaluates differences in uncorrected visual acuity (UCVA) results obtained using HOTV and Tumbling E logMAR charts among children aged 3-15 years.	Baseline vision testing at enrollment (single study visit)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged 3 to 18 years
Have been lived in the research areas for at least one year, and will not move to other places in the following two years
Parents or guardians sign an informed consent form, and children over 6 years old need oral consent to participate

Exclusion Criteria:

Mental diseases, unable to cooperate to complete the eye assessment
Ophthalmic diseases, inability to cooperate to complete the inspection

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Students aged from 3 to 18 years old were recruited from schools to enroll the study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xun Xu, MD	Contact	021-53555032	86	drxuxun@sjtu.edu.cn
Xiangui He, PhD	Contact	15000755422	86	xianhezi@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai Eye Disease Prevention & Treatment Center	Recruiting	Shanghai	Shanghai Municipality	200040	China

Condition Browse Module

MeSH Terms

ID	Term
D009216	Myopia

Ancestor Terms

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided