NCT05770661

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30,000

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Mar 2023

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress83%
Mar 2023Dec 2026

First Submitted

Initial submission to the registry

March 5, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

March 10, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 15, 2023

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

3.8 years

First QC Date

March 5, 2023

Last Update Submit

December 11, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Axial length

    Axial length in millimeter was examined by IOL Master

    2023-2026

Secondary Outcomes (1)

  • Axial length elongation

    2023-2026

Other Outcomes (1)

  • Comparison of visual acuity outcomes obtained by VA charts with different optotypes among children

    Baseline vision testing at enrollment (single study visit)

Study Arms (2)

Myopes

To collect the ocular data among myopic children.

Non-myopes

To collect the ocular data among non-myopic children.

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Shanghai Eye Disease Prevention & Treatment Center

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

Shanghai Eye Disease Prevention and Treatment Center

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Central Study Contacts

Xiangui He, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

March 5, 2023

First Posted

March 15, 2023

Study Start

March 10, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

December 18, 2025

Record last verified: 2025-12

Locations