Academic Performance and Refractive Error | NCT04338880

Studies
Academic Performance and Refractive Error

NCT04338880

Sponsor

Sun Yat-sen University

Status

Unknown status

Last Update Posted

Apr 8, 2020Actual

Enrollment

10,000Estimated

Phase

Not provided

Conditions

Refractive Errors

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

Apr 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2016Actual

Primary Completion Date

Jun 30, 2019Actual

Completion Date

Dec 1, 2020Estimated

First Submitted Date

Apr 7, 2020

First Submission Date that Met QC Criteria

Apr 7, 2020

First Posted Date

Apr 8, 2020Actual

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

Apr 7, 2020

Last Update Posted Date

Apr 8, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

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.

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

10,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the changes of spherical equivalent refractive (RSE)	A multi-linear regression was used.	up to 3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

schoolchildren in the 1st to 9th grades

Exclusion Criteria:

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yahan Yang, M.D.	Contact	+8615521013933		yah.yang39@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhognshan Ophthalmic Center, Sun Yat-sen University	Recruiting	Guangzhou	Guangdong	510080	China