Correlation Between Refraction and Biometric Parameters | NCT04346251

Studies
Correlation Between Refraction and Biometric Parameters

NCT04346251

Sponsor

Sun Yat-sen University

Status

Unknown status

Last Update Posted

Apr 15, 2020Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Refractive Errors

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 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

Nov 1, 2017Actual

Primary Completion Date

Nov 30, 2019Actual

Completion Date

Dec 1, 2020Estimated

First Submitted Date

Apr 10, 2020

First Submission Date that Met QC Criteria

Apr 10, 2020

First Posted Date

Apr 15, 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

Apr 10, 2020

Last Update Posted Date

Apr 15, 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

To document the refractive status of Chinese schoolchildren and evaluate the association between the degree of refraction and biometric parameters.

Detailed Description

In this study, we will analyze the refractive status of schoolchildren and compare the ocular biometrics, including spherical equivalent refraction (SER), pupil distance (PD), corneal curvature (CC), high order aberration (HOA), and central corneal thickness (CCT) between boys and girls. Additionally, we investigate the correlation between the SER in diopters and the other biometric parameters, including PD, CC, HOA, CCT, and body mass index (BMI).

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

1,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
refractive error in diopters and biometric Parameters	Multiple regression analysis will be performed to evaluate the correlations between SER and the other biometric parameters	up to 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Schoolchildren aged from 6 to 15 years

Exclusion Criteria:

with previous histories of cataracts, keratitis, strabismus, or other visual impairments
with history of previous eye surgery
with unreliable auto-refraction values
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

15 Years

Standard Ages

Child

Study Population

Schoolchildren aged 6 to 15 years will be included in this cross-sectional study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Haotian Lin, Ph.D	Contact	+86-020-87330274		gddlht@aliyun.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhognshan Ophthalmic Center, Sun Yat-sen University	Recruiting	Guangzhou	Guangdong	510080	China