Dongguan Eye Study of Schoolchildren and Adolescents（DESSA） | NCT03409094

Studies
Dongguan Eye Study of Schoolchildren and Adolescents（DESSA）

NCT03409094

Sponsor

Sun Yat-sen University

Status

Withdrawn

Last Update Posted

Apr 16, 2019Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Child Development

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 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

equipments and staff are unavailable.

Expanded Access Info

Start Date

Jan 1, 2019Estimated

Primary Completion Date

Apr 1, 2021Estimated

Completion Date

Apr 1, 2021Estimated

First Submitted Date

Jan 17, 2018

First Submission Date that Met QC Criteria

Jan 23, 2018

First Posted Date

Jan 24, 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

Apr 13, 2019

Last Update Posted Date

Apr 16, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xiulan Zhang, Vice Director of Glaucoma Department,Director of Clinical Research Center, Director of Institution of Drug Clinical Trials, Sun Yat-sen UniversityPrincipal Investigator

Lead Sponsor

Sun Yat-sen UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

This is a study to report the change of ocular biometry of schoolchildren and adolescents as well as its association with birth parameters in China.

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

0Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes of ocular fundus parameter in schoolchildren and adolescents	Record the change of retinal thickness during the follow-up periods.	3 years

Secondary Outcomes

Measure	Description	Time Frame
Changes of ocular biometry measurement in schoolchildren and adolescents	Record the change of choroidal thickness during the follow-up periods.	3 years
Changes of ocular anterior segment in schoolchildren and adolescents

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Schoolchildren and adolescents aged 7 to18 years in Dongguan
Parents are willing to sign the informed written consent.

Exclusion Criteria:

Those without informed written consent or unable to obey the study procedures

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Schoolchildren and adolescents ranging from 7 to 18 years old in Dongguan.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Xiulan Zhang, MD,PhD	Zhongshan Ophthalmic Center, Sun Yat-sen University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhongshan Ophthalmic Center		Guangzhou	Guangdong	510060	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided