Ocular Development and Refractive Error Changes Among Chi... | NCT03589937

Studies
Ocular Development and Refractive Error Changes Among Children and Adolescent - A Longitudinal Study

NCT03589937

Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Status

Unknown status

Last Update Posted

Mar 29, 2022Actual

Enrollment

7,050Actual

Phase

Not provided

Conditions

Myopia

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

Mar 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 20, 2018Actual

Primary Completion Date

Jul 20, 2024Estimated

Completion Date

Jul 20, 2024Estimated

First Submitted Date

Jun 20, 2018

First Submission Date that Met QC Criteria

Jul 17, 2018

First Posted Date

Jul 18, 2018Actual

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

Mar 14, 2022

Last Update Posted Date

Mar 29, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yizhi Liu, Professor, Zhongshan Ophthalmic Center, Sun Yat-sen UniversityPrincipal Investigator

Lead Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen UniversityOTHER

Collaborators

Not provided

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

The study aims to observe the ocular development and refractive error changes among school children and adolescents

Detailed Description

This study aims to observe the refractive error changes of school children and adolescents for 3 years, and to collect data of ocular structural parameters, family history and environmental factors so as to understand the natural course and internal laws of myopia progression.

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

7,050Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
spherical equivalent change	SE was measured by autorefractometer with cycloplegic once a year at scheduled time Every 12 months, follow up for 3 years	examine every 12 months, follow up for 3 years

Secondary Outcomes

Measure	Description	Time Frame
Axial length	Axial length is measured by IOMaster once a year at scheduled time	examine every 12 months, follow up for 3 years
Anterior chamber depth	Anterior chamber depth is measured by IOMaster once a year at scheduled time

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

School children and adolescent at the age of 3(Junior Kindergarten), 6(Grade 1), 9(grade 4), 12(grade 7).
No allergy to tropicamide or topical anesthetics
written informed consent is obtained from guardian
Be willing to cooperate with the relevant ophthalmological examination and complete the questionnaire.

Exclusion Criteria:

No history of eye diseases
Receiving or has been received treatment of myopia control such as atropine eye drops, corneal contact lens or myopic glasses
A history of allergy to topic amide or topical anesthetics
Have severe systemic disease
Missing ability to give informed consent

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

School children and adolescent at the age of 3(Junior Kindergarten), 6(Grade 1), 9(grade 4), 12(grade 7)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yizhi LIU, PhD	Zhongshan Ophthalmic Center, Sun Yat-san University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zengcheng		Guangzhou	Guangdong	510000	China
Zengcheng

Condition Browse Module

MeSH Terms

ID	Term
D009216	Myopia
D012030	Refractive Errors

Ancestor Terms

ID	Term
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided