Prevalence of Blindness, Visual Impairment in Chao Nan Area, China

October 29, 2019 updated by: ZHANG XIUJUAN, Chinese University of Hong Kong

Prevalence of Blindness, Visual Impairment and Main Avoidable Causes in Chao Nan Area

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.

Study Overview

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

Observational

Enrollment (Actual)

3700

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: XIUJUAN ZHANG, PhD, Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2012

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

October 24, 2019

First Submitted That Met QC Criteria

October 26, 2019

First Posted (ACTUAL)

October 29, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 31, 2019

Last Update Submitted That Met QC Criteria

October 29, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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