Eye Health in Children and Adolescents: Repeated Cross-se... | NCT04433130

Studies
Eye Health in Children and Adolescents: Repeated Cross-sectional Survey

NCT04433130

Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Status

Unknown status

Last Update Posted

Jul 24, 2020Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Visual Acuity

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

Jul 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

Jun 16, 2020Actual

Primary Completion Date

Aug 31, 2024Estimated

Completion Date

Aug 31, 2024Estimated

First Submitted Date

Jun 12, 2020

First Submission Date that Met QC Criteria

Jun 12, 2020

First Posted Date

Jun 16, 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

Jul 22, 2020

Last Update Posted Date

Jul 24, 2020Actual

Name	Class
Sun Yat-sen University	OTHER
Chinese University of Hong Kong	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Detailed Description

The investigator will take a mixed-methods approach to gather relevant information from both children or adolescents, and their parents on profiles of eye health, as well as routinely available indicators. This includes a series of baselining and follow-up analyses of cohort data collected on epidemiological, clinical, therapeutic, and service aspects of eye health (e.g., social environment, preventive behaviours, risk factors, knowledge and attitudes, health and social care, etc.) and individual-level outcomes (e.g., clinical parameters and symptoms, biomarkers, self-reported measures, risk profiles, etc.).

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

300Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
visual acuity	The primary aims of the research project are to explore the profiles of eye health and how lifestyle behaviours, social environment, and individual risk factors are associated with health outcomes.	Baseline and changes up to 4 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion:

Subjects with valid information on eye health-related profiles
Completion of eye health examination delivered by trained ophthalmic professionals

Exclusion:

Inability to give informed consent
Unable to retrieve individual records on eye health examination

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Subjects seeking care on refractive error or vision problems and their parents

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhongshan Ophthalmic Center, Sun Yat-sen University	Recruiting	Guangzhou	Guangdong	510000	China