- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04143334
Prevalence of Blindness, Visual Impairment in Chao Nan Area, China
Prevalence of Blindness, Visual Impairment and Main Avoidable Causes in Chao Nan Area
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Among the 3700 people, 169 (4.6%) could not be reached, 20 (0.5%) were unable to communicate, and 27 (0.7%) refused. Consequently, 3484 persons (response rate 94.2%) with a mean (±SD) age of 64.4±9.8 years were examined. These included 1397 men (40.1%) with an average age of 65.3 ±9.6 years and 2087 women (59.9%) with an average age of 63.8±9.8 years.
Of the 2145 subjects (95.3%,2145/2250), 327 (15.2%) refused, and 2 (0.1%) were unable to cooperate for examination. Consequently, 1816 subjects (1816/2145, 84.7%) with a mean (±SD) age of 64.4±9.6 years received the conventional ophthalmic examination in the mobile eye clinic (figure 1). These included 686 men (37.8%) with an average age of 65.5±9.4 years and 1130 women (62.2%) with an average age of 63.8±9.6 years.
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
RAAB survey
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.
|
|
|
conventional survey
All the recruited participants underwent ophthalmic examination according to the RAAB protocol and then 60% of them were re-examined with instruments in a mobile eye clinic set up in a village center on the same day.
Examination in the mobile clinic included standardized visual acuity (VA) tests using logarithm of the minimum angle resolution charts, refraction, slit-lamp biomicroscopy, and dilated fundal examination with a binocular indirect ophthalmoscope.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the prevalence of blindness and visual impairment (VI) and main avoidable causes in Chaonan, China
Time Frame: one year
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the diagnostic accuracy of RAAB
Time Frame: one year
|
To evaluate the diagnostic accuracy of Rapid Assessment of Avoidable Blindness (RAAB)
|
one year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: XIUJUAN ZHANG, PhD, Chinese University of Hong Kong
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRE-2011.389
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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