NCT03409094

Brief Summary

This is a study to report the change of ocular biometry of schoolchildren and adolescents as well as its association with birth parameters in China.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 24, 2018

Completed
11 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

2.2 years

First QC Date

January 17, 2018

Last Update Submit

April 13, 2019

Conditions

Child Development

Outcome Measures

Primary Outcomes (1)

  • Changes of ocular fundus parameter in schoolchildren and adolescents

    Record the change of retinal thickness during the follow-up periods.

    3 years

Secondary Outcomes (2)

  • Changes of ocular biometry measurement in schoolchildren and adolescents

    3 years

  • Changes of ocular anterior segment in schoolchildren and adolescents

    3 years

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Schoolchildren and adolescents ranging from 7 to 18 years old in Dongguan.

You may qualify if:

  • Schoolchildren and adolescents aged 7 to18 years in Dongguan
  • Parents are willing to sign the informed written consent.

You may not qualify if:

  • Those without informed written consent or unable to obey the study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510060, China

Location

Study Officials

  • Xiulan Zhang, MD,PhD

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice Director of Glaucoma Department,Director of Clinical Research Center, Director of Institution of Drug Clinical Trials

Study Record Dates

First Submitted

January 17, 2018

First Posted

January 24, 2018

Study Start

January 1, 2019

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

April 16, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)