NCT04346251

Brief Summary

To document the refractive status of Chinese schoolchildren and evaluate the association between the degree of refraction and biometric parameters.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

November 1, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 15, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

April 15, 2020

Status Verified

April 1, 2020

Enrollment Period

2.1 years

First QC Date

April 10, 2020

Last Update Submit

April 10, 2020

Conditions

Refractive Errors

Outcome Measures

Primary Outcomes (1)

  • refractive error in diopters and biometric Parameters

    Multiple regression analysis will be performed to evaluate the correlations between SER and the other biometric parameters

    up to 1 year

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Schoolchildren aged 6 to 15 years will be included in this cross-sectional study.

You may qualify if:

  • Schoolchildren aged from 6 to 15 years

You may not qualify if:

  • with previous histories of cataracts, keratitis, strabismus, or other visual impairments
  • with history of previous eye surgery
  • with unreliable auto-refraction values
  • unwilling to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhognshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Central Study Contacts

Haotian Lin, Ph.D

CONTACT

+86-020-87330274gddlht@aliyun.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 10, 2020

First Posted

April 15, 2020

Study Start

November 1, 2017

Primary Completion

November 30, 2019

Study Completion

December 1, 2020

Last Updated

April 15, 2020

Record last verified: 2020-04

Locations

CN(1)