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NCT01743781 Clinical Trial

Uptake of Comprehensive Eye Examination Trial

Glaucoma Clinical Trial

Official title:
The Impact of Multimedia Education on Uptake of Comprehensive Eye Examination in Rural Southern China:A Randomized, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01743781
Other study ID # ZOC-CREST2
Secondary ID
Status Completed
Phase N/A
First received November 21, 2012
Last updated January 3, 2014
Start date July 2013
Est. completion date September 2013

Study information
Verified date January 2014
Source Sun Yat-sen University
Contact n/a
Is FDA regulated No
Health authority China: Ministry of Science and Technology
Study type Interventional

Clinical Trial Summary

1. To evaluate a educational intervention promoting acceptance of comprehensive eye examination in rural Guangdong.

2. To evaluate the impact of acceptance of comprehensive eye examination in rural Guangdong.

Description:

A comprehensive eye examination includes visual acuity, slitlamp exam, pupil exam, intraocular pressure, gonioscope lens and 90D lens with slitlamp exam fundus. A number of eye diseases are irreversible at on early stage. Both glaucoma and diabetic retinopathy(DR)are frequently asymptomatic until significant, often-irreversible, damage to the vision has already occurred. It has been estimated that only 10% of persons in India with glaucoma are diagnosed, and the Handan Eye Survey reports that only 10% of persons with diabetes in rural areas of China have received diabetic eye care. In order to deliver effective care for DR and glaucoma in areas with limited resources, education of patients and interventions to promote compliance among patients will both be needed.

Recruitment information / eligibility
Status Completed
Enrollment 459
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Both
Age group 40 Years and older
Eligibility Inclusion Criteria:

- age =40 years who have never had a comprehensive eye examination

Exclusion Criteria:

- inability to join informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Behavioral:
• video
view a 10-minute informational video about comprehensive eye examination

Locations
Country Name City State
China 54 Xianlie Rd Guangzhou Guangdong

Sponsors (3)
Lead Sponsor Collaborator
Sun Yat-sen University Orbis, The World Diabetes Foundation

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary The acceptance rate of comprehensive eye examination in both groups acceptance rate of comprehensive eye examination 1 day No
Secondary knowledges of eye disease and attitude of eye examination knowledges of eye disease and attitude of eye examination 1 day No
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