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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03533647
Other study ID # SYSU-OPH-003
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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