Development and Pathological Changes of High Myopia Among Children and Adolescents in China

• Conditions: High Myopia
• Interventions: Other: Observational

• Registration Number: NCT03533647
• Lead Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

Brief Summary

The study aims to observe the relationship between the changes of ocular structure parameters and pathological changes among children and adolescents with high myopia. Environmental factors and family history will also be collected to explore their impacts on high myopia progression.

Detailed Description

This study aims to observe children and adolescents with high myopia for 3 years, and to collect data of ocular pathological changes, family history and environmental factors so as to understand the natural course and internal laws of the development of high myopia.

Study Timeline

• Study First Submitted: 2018-05-10
• Study First Submitted QC: 2018-05-10
• Study Start: 2018-05-14
• Study First Posted: 2018-05-23
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-18
• Last Update Posted: 2018-06-20
• Primary Completion: 2021-05-13
• Study Completion: 2021-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1400

Inclusion Criteria

• 9 to 18 years old school students in Guangzhou, with either eye had myopia equal or greater than 6.0D
• Or 6 to 8 years old school students in Guangzhou, with either eye had myopia equal or greater than 3.0D
• Written informed consent for study participation
• Be willing to cooperate with the relevant ophthalmological examination and complete the questionnaire.

Exclusion Criteria

• None school students in Guangzhou
• Other contraindications
• A history of allergy to tropicamide or topical anesthetics
• Missing ability to give informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
entire cohort (observational)	Observational	none (observational study)

Primary Outcome Measures

Name	Time	Method
To observe the relationship between the changes of ocular structure parameters and pathological changes among children with high myopia.	examine every 12 months, follow up 3 years	examine the ocular pathological changes

Secondary Outcome Measures

Name	Time	Method
To explore the impact of environmental factors and genetic factors on the progression among children and adolescents with high myopia	examine every 12 months, follow up 3 years	axial length, refractive error changes, environmental factors, family history, exercise time, eye care habits, form of exercise

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center, Sun Yet-san University; 🇨🇳 Guangzhou, Guangdong, China