Ocular Development and Refractive Error Changes Among Children and Adolescent - A Longitudinal Study

Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03589937

Collaborator

(none)

7,050

Enrollment

Locations

Anticipated Duration (Months)

3525

Patients Per Site

48.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study aims to observe the ocular development and refractive error changes among school children and adolescents

Condition or Disease	Intervention/Treatment	Phase
Myopia

Detailed Description

This study aims to observe the refractive error changes of school children and adolescents for 3 years, and to collect data of ocular structural parameters, family history and environmental factors so as to understand the natural course and internal laws of myopia progression.

Study Design

Study Type:

Observational

Actual Enrollment :

7050 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Longitudinal Study on Ocular Development and Refractive Error Changes Among children-and Adolescent

Actual Study Start Date :

Jul 20, 2018

Anticipated Primary Completion Date :

Jul 20, 2024

Anticipated Study Completion Date :

Jul 20, 2024

Outcome Measures

Primary Outcome Measures

spherical equivalent change [examine every 12 months, follow up for 3 years]
SE was measured by autorefractometer with cycloplegic once a year at scheduled time Every 12 months, follow up for 3 years

Secondary Outcome Measures

Axial length [examine every 12 months, follow up for 3 years]
Axial length is measured by IOMaster once a year at scheduled time
Anterior chamber depth [examine every 12 months, follow up for 3 years]
Anterior chamber depth is measured by IOMaster once a year at scheduled time
lens thickness [examine every 12 months, follow up for 3 years]
lens thickness is measured by IOMaster once a year at scheduled time
Vitreous length [examine every 12 months, follow up for 3 years]
Vitreous length was measured by IOMaster once a year at scheduled time
Environmental factor [examine every 12 months, follow up for 3 years]
Time of outdoor activities & short range reading,measured by questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 12 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

School children and adolescent at the age of 3(Junior Kindergarten), 6(Grade 1), 9(grade 4), 12(grade 7).
No allergy to tropicamide or topical anesthetics
written informed consent is obtained from guardian
Be willing to cooperate with the relevant ophthalmological examination and complete the questionnaire.

Exclusion Criteria:

No history of eye diseases
Receiving or has been received treatment of myopia control such as atropine eye drops, corneal contact lens or myopic glasses
A history of allergy to topic amide or topical anesthetics
Have severe systemic disease
Missing ability to give informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zengcheng	Guangzhou	Guangdong	China	510000
2	Zengcheng	Guangzhou	Guangdong	China

Sponsors and Collaborators

Zhongshan Ophthalmic Center, Sun Yat-sen University

Investigators

Principal Investigator: Yizhi LIU, PhD, Zhongshan Ophthalmic Center, Sun Yat-san University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yizhi Liu, Professor, Zhongshan Ophthalmic Center, Sun Yat-sen University

ClinicalTrials.gov Identifier:

NCT03589937

Other Study ID Numbers:

SYSU-OPH-004

First Posted:

Jul 18, 2018

Last Update Posted:

Mar 29, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Yizhi Liu, Professor, Zhongshan Ophthalmic Center, Sun Yat-sen University

refractive error

ocular structural parameters

Additional relevant MeSH terms:

Refractive Errors

Study Results

No Results Posted as of Mar 29, 2022