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

• Conditions: Myopia

• Registration Number: NCT03589937
• Lead Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-06-20
• Study First Submitted QC: 2018-07-17
• Study First Posted: 2018-07-18
• Study Start: 2018-07-20
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-14
• Last Update Posted: 2022-03-29
• Primary Completion: 2024-07-20
• Study Completion: 2024-07-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 7050

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Axial length	examine every 12 months, follow up for 3 years	Axial length 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
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
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

Trial Locations

Locations (1)

Zengcheng; 🇨🇳 Guangzhou, Guangdong, China