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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04226729
Other study ID # VISION202201
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 25, 2022
Est. completion date April 30, 2023

Study information

Verified date August 2022
Source Sun Yat-sen University
Contact Yifan Xiang, M.D
Phone 18826234461
Email 565098660@qq.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date April 30, 2023
Est. primary completion date December 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 12 Years
Eligibility Inclusion Criteria: - age from 3 to 12 years old Exclusion Criteria: - diagnosed with nervous system disease before

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary the visual information processing function collected with the electroencephalogram recorded at enrollment
Primary best corrected visual acuity collected with visual acuity chart recorded at enrollment
Secondary refractive status the refractive status of both eyes recorded at enrollment
Secondary intraocular pressure the intraocular pressure of both eyes recorded at enrollment
Secondary fundus picture the fundus pictures of both eyes recorded at enrollment
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