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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04346251
Other study ID # CCPMOH2017-China-1101
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2017
Est. completion date December 1, 2020

Study information

Verified date April 2020
Source Sun Yat-sen University
Contact Haotian Lin, Ph.D
Phone +86-020-87330274
Email gddlht@aliyun.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date December 1, 2020
Est. primary completion date November 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 15 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Zhognshan Ophthalmic Center, Sun Yat-sen University 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 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
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