NCT04338880

Brief Summary

Refractive errors constitute the leading cause of visual disability worldwide and that myopia progresses dramatically when students reach school age. Studies from different countries have reported inconsistent associations between educational outcomes and refractive errors. Therefore, our study aimed to assess the associations of high academic performance with ametropia prevalence and myopia progression in Chinese schoolchildren base on a multicohort observational design.

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
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 8, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

April 8, 2020

Status Verified

April 1, 2020

Enrollment Period

2.8 years

First QC Date

April 7, 2020

Last Update Submit

April 7, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • the changes of spherical equivalent refractive (RSE)

    A multi-linear regression was used.

    up to 3 years

Eligibility Criteria

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

A prospective multicohort observational study of schoolchildren who studied in the 1st to 9th grades was performed.

You may qualify if:

  • schoolchildren in the 1st to 9th grades

You may not qualify if:

  • schoolchildren unwilling to participate
  • had a history of wearing rigid contact lenses, medical treatment or diseases that could cause poor vision or negatively affect the academic outcomes
  • with unreliable auto-refraction values

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

Study Design

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

Study Record Dates

First Submitted

April 7, 2020

First Posted

April 8, 2020

Study Start

September 1, 2016

Primary Completion

June 30, 2019

Study Completion

December 1, 2020

Last Updated

April 8, 2020

Record last verified: 2020-04

Locations