Environmental Health and Myopia Prevention and Control | NCT04161326

Studies
Environmental Health and Myopia Prevention and Control

NCT04161326

Sponsor

Sun Yat-sen University

Status

Unknown status

Last Update Posted

Feb 25, 2020Actual

Enrollment

100,000Estimated

Phase

Not provided

Conditions

Refractive Errors
Myopia (Disorder)

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

Feb 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

Jan 1, 2016Actual

Primary Completion Date

Dec 30, 2019Actual

Completion Date

Dec 30, 2021Estimated

First Submitted Date

Nov 11, 2019

First Submission Date that Met QC Criteria

Nov 11, 2019

First Posted Date

Nov 13, 2019Actual

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

Feb 22, 2020

Last Update Posted Date

Feb 25, 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

Myopia is one of the major causes of low visual acuity during childhood. It is generally more prevalent in urban areas than in rural areas. Current evidence does not address our understanding of the myopia incidence and development and associated risk geographic factors, such as green spaces. Therefore, our study aimed to evaluate the association between geographic factors and myopia base on a population-based large-scaled cohort 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

100,000Estimated

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 4th grades

Exclusion Criteria:

schoolchildren unwilling to participate

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

9 Years

Standard Ages

Child

Study Population

A prospective longitudinal cohort study of schoolchildren who studied in the 1st to 4th 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
Zhongshan Ophthalmic Center, Sun Yat-sen University	Recruiting	Guangzhou	Guangdong	510000	China

Condition Browse Module

MeSH Terms

ID	Term
D012030	Refractive Errors
D009216	Myopia

Ancestor Terms

ID	Term
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided