Clinical trial NCT03533647: Development and Pathological Changes of High Myopia Among Children and Adolescents in China
Official title: A Longitudinal Study on the Development and Pathological Changes Among Children and Adolescents With High Myopia in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: High Myopia
Keywords: high myopia
ocular biometric parameters
adolescent
children
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-05-23
Enrollment: 1400
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 6 to 18 years old school students in Guangzhou. Age between 9-18 years old with either eye had myopia equal or greater than 6.0D ,age between 6-8 years old with either eye had myopia equal or greater than 3.0D

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.

Eligibility criteria: 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

Primary outcomes:
measure: To observe the relationship between the changes of ocular structure parameters and pathological changes among children with high myopia.
timeFrame: examine every 12 months, follow up 3 years
Secondary outcomes:
measure: To explore the impact of environmental factors and genetic factors on the progression among children and adolescents with high myopia
timeFrame: examine every 12 months, follow up 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yet-san University
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Yizhi LIU, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Lin LL, Shih YF, Hsiao CK, Chen CJ. Prevalence of myopia in Taiwanese schoolchildren: 1983 to 2000. Ann Acad Med Singap. 2004 Jan;33(1):27-33.
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.