The Incidence and Progression of Myopia: Cohort Study | NCT03244670

Studies
The Incidence and Progression of Myopia: Cohort Study

NCT03244670

Sponsor

Sun Yat-sen University

Status

Completed

Last Update Posted

Sep 20, 2019Actual

Enrollment

350Actual

Phase

Not provided

Conditions

Myopia

Interventions

Observation study only, no specific intervention

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

Sep 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 15, 2017Actual

Primary Completion Date

Jul 19, 2019Actual

Completion Date

Sep 19, 2019Actual

First Submitted Date

Aug 7, 2017

First Submission Date that Met QC Criteria

Aug 7, 2017

First Posted Date

Aug 9, 2017Actual

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

Sep 19, 2019

Last Update Posted Date

Sep 20, 2019Actual

Name	Class
Essilor International	INDUSTRY

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

A cohort study on incidence and progression of myopia in a group of medical students

Detailed Description

A prospective cohort study to investigate the refractive error development, progression and their risk factors in young adult population comprises a group of medical students in China for two years

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

350Actual

Name	Type	Description	Arm Group Labels	Other Names
Observation study only, no specific intervention	Other	Observation study only, no specific intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
refraction	The participants will be measured for their refractive error by optometrist, and observe the rate of progression of myopia	Change from baseline for two years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Volunteer subject, , willing to follow the protocol and able to read, comprehend and sign the informed consent form,
Age between 17 and 23 years

Exclusion Criteria:

Vulnerability of the subject,
Participation in another study which might have an influence on vision or interfere with study assessments,
Aphakic or pseudophakic (intraocular lens)
Participants who are wearing ortho-K lenses, or undergone any kind of myopia control treatments or undergone refractive surgery.
Any current or evolving pathology manifested in the eye or the appendages which might have an influence on vision, or interfere with study assessments (e.g. AMD, glaucoma…),
Any previous ocular surgery which might have an influence on vision or interfere with study assessments (e.g. iridectomy, refractive surgery…),
Any untreated and/or uncontrolled systemic condition which might have an influence on vision, or interfere with study assessments (e.g. uncontrolled diabetes, uncontrolled high blood pressure…),
Any medical treatment or medication which might have an influence on vision or interfere with study assessments (e.g. antidepressants, drugs with atropinic effects…),

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

23 Years

Standard Ages

ChildAdult

Study Population

First-year medical college student from Zhongshan University

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Chen xiang	Associate Professor	Principal Investigator

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

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases