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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04143334
Other study ID # CRE-2011.389
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2012
Est. completion date December 1, 2016

Study information

Verified date October 2019
Source Chinese University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study will provide a profile of blindness/visual impairment, avoidable blindness and cataract surgery service in Chaonan, mainland China. We also evaluate the diagnostic accuracy of Rapid Assessment of Avoidable Blindness (RAAB) comparison with conventional survey.


Description:

This proposal describes a population-based study aimed at determining the prevalence of visual impairment, blindness and major causes in adults age 50 years old and above in Chaonan County of Guangdong province, where one of the Project Vision Charity Eye center was founded in 2009.

In the proposed study, we will examine 3700 Chaonan County residents aged 50 years and older, selected via a clustered, randomized sampling with probability proportional to size (PPS). The cluster will be at the village level, 50 subjects aged 50 years and older will be examined in each cluster includes Visual acuity, torch light, and fundus review, the major cause of blindness or visual impairment will be determined. We also randomly recruited 60% clusters,total 2250 participants, from RAAB survey to conduct a detailed conventional eye examination.

This study will provide a profile of blindness/visual impairment, avoidable blindness and cataract surgery service in Chaonan. we will evaluate the diagnostic accuracy of Rapid Assessment of Avoidable Blindness (RAAB) comparison with conventional survey. . It will provide important public health issues for the purposes of establishing a sustainable and suitable model to eliminate the cataract blindness in China.


Recruitment information / eligibility

Status Completed
Enrollment 3700
Est. completion date December 1, 2016
Est. primary completion date December 1, 2015
Accepts healthy volunteers
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria:

- aged 50 years and above

- In each household all persons , residing in the household for six months or more over the past year

- "Residing in the household" is defined as "sharing meals from the same kitchen with the other members of the household for at least 6 months in a year. Exclude any visitors.

Exclusion Criteria:

- age <50 years old

- Visitors in the villages

- Residing in the household< 6 months

Study Design


Intervention

Diagnostic Test:
Conventional survey


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Chinese University of Hong Kong

References & Publications (1)

Li EY, Liu Y, Zhan X, Liang YB, Zhang X, Zheng C, Jhanji V, Xu P, Chang DF, Lam DS. Prevalence of blindness and outcomes of cataract surgery in Hainan Province in South China. Ophthalmology. 2013 Nov;120(11):2176-83. doi: 10.1016/j.ophtha.2013.04.003. Epu — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary the prevalence of blindness and visual impairment (VI) and main avoidable causes in Chaonan, China the prevalence of blindness and visual impairment (VI), and report the avoidable causes, including cataract in Chaonan Region, Guangdong Province, southern China one year
Secondary the diagnostic accuracy of RAAB To evaluate the diagnostic accuracy of Rapid Assessment of Avoidable Blindness (RAAB) one year
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