NCT04226729

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 30, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
2 years until next milestone

Study Start

First participant enrolled

January 25, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

August 16, 2022

Status Verified

August 1, 2022

Enrollment Period

11 months

First QC Date

December 30, 2019

Last Update Submit

August 14, 2022

Conditions

HealthyVision; Disorder, Loss

Outcome Measures

Primary Outcomes (2)

  • 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 (3)

  • refractive status

    recorded at enrollment

  • intraocular pressure

    recorded at enrollment

  • fundus picture

    recorded at enrollment

Study Arms (3)

Healthy group

Mild visual impairment group

Moderate and severe visual impairment group

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • age from 3 to 12 years old

You may not qualify if:

  • diagnosed with nervous system disease before

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity

Guangzhou, Guangdong, 510060, China

RECRUITING

Study Officials

  • Haotian Lin, M.D,Ph.D

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yifan Xiang, M.D

CONTACT

18826234461565098660@qq.com

Haotian Lin, M.D,Ph.D

CONTACT

13802793086haot.lin@hotmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

December 30, 2019

First Posted

January 13, 2020

Study Start

January 25, 2022

Primary Completion

December 30, 2022

Study Completion

April 30, 2023

Last Updated

August 16, 2022

Record last verified: 2022-08

Locations

CN(1)