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

High Myopia Clinical Trial

Official title:

A Longitudinal Study on the Development and Pathological Changes Among Children and Adolescents With High Myopia in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03533647
• Other study ID #: SYSU-OPH-003
• Status: Recruiting
• Start date: May 14, 2018
• Est. completion date: May 31, 2021

Study information

• Verified date: June 2018
• Source: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Contact: Yuting LI, master
• Phone: +86-020-87334687
• Email: ytdorothy[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1400
• Est. completion date: May 31, 2021
• Est. primary completion date: May 13, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• High Myopia
• Myopia

Intervention

Other:
• Observational
none (observational study)

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center, Sun Yet-san University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhongshan Ophthalmic Center, Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (3)

Holden BA, Fricke TR, Wilson DA, Jong M, Naidoo KS, Sankaridurg P, Wong TY, Naduvilath TJ, Resnikoff S. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016 May;123(5):1036-42. doi: 10.1016/j.ophtha.2016.01.006. Epub 2016 Feb 11. Review. — View Citation

Lin LL, Shih YF, Hsiao CK, Chen CJ. Prevalence of myopia in Taiwanese schoolchildren: 1983 to 2000. Ann Acad Med Singapore. 2004 Jan;33(1):27-33. — View Citation

Sun J, Zhou J, Zhao P, Lian J, Zhu H, Zhou Y, Sun Y, Wang Y, Zhao L, Wei Y, Wang L, Cun B, Ge S, Fan X. High prevalence of myopia and high myopia in 5060 Chinese university students in Shanghai. Invest Ophthalmol Vis Sci. 2012 Nov 1;53(12):7504-9. doi: 10.1167/iovs.11-8343. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To observe the relationship between the changes of ocular structure parameters and pathological changes among children with high myopia.	examine the ocular pathological changes	examine every 12 months, follow up 3 years
Secondary	To explore the impact of environmental factors and genetic factors on the progression among children and adolescents with high myopia	axial length, refractive error changes, environmental factors, family history, exercise time, eye care habits, form of exercise	examine every 12 months, follow up 3 years

External Links

•   sample size reference