Associations Between Vision and Brain Function | NCT04226729

Studies
Associations Between Vision and Brain Function

NCT04226729

Sponsor

Sun Yat-sen University

Status

Unknown status

Last Update Posted

Aug 16, 2022Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Healthy
Vision; Disorder, Loss

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

Aug 2022

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

Jan 25, 2022Actual

Primary Completion Date

Dec 30, 2022Estimated

Completion Date

Apr 30, 2023Estimated

First Submitted Date

Dec 30, 2019

First Submission Date that Met QC Criteria

Jan 10, 2020

First Posted Date

Jan 13, 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

Aug 14, 2022

Last Update Posted Date

Aug 16, 2022Actual

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

Case-control studies and meta-analysis have reported that several ocular features, especially the thickness of the peripapillary retinal nerve fiber layer and visual acuity, are related to the brain degeneration and cognitive impairment. In our study, we aim to quantitatively assess ocular features using structural and functional indicators and define its associations with brain development and intelligence in children.

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

200Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the visual information processing function	collected with the electroencephalogram	recorded at enrollment
best corrected visual acuity	collected with visual acuity chart	recorded at enrollment

Secondary Outcomes

Measure	Description	Time Frame
refractive status	the refractive status of both eyes	recorded at enrollment
intraocular pressure	the intraocular pressure of both eyes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age from 3 to 12 years old

Exclusion Criteria:

diagnosed with nervous system disease before

Accepts Healthy Volunteers

Yes

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

Healthy children aged 3 to 12 years old. Patients who have been diagnosed with nervous system diseases were excluded.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yifan Xiang, M.D	Contact	18826234461		565098660@qq.com
Haotian Lin, M.D,Ph.D	Contact	13802793086		haot.lin@hotmail.com

Overall Officials

Name	Affiliation	Role
Haotian Lin, M.D,Ph.D	Zhongshan Ophthalmic Center, Sun Yat-sen University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity	Recruiting	Guangzhou	Guangdong	510060	China

Label	Type	Description	Intervention Names
Healthy group
Mild visual impairment group
Moderate and severe visual impairment group