Back to resultsUptake of Comprehensive Eye Examination Trial
Primary Purpose
Glaucoma, Diabetic Retinopathy
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
video
Sponsored by
About this trial
This is an interventional prevention trial for Glaucoma focused on measuring comprehensive eye examination, acceptance, glaucoma, diabetic retinopathy
Eligibility Criteria
Inclusion Criteria:
- age ≥40 years who have never had a comprehensive eye examination
Exclusion Criteria:
- inability to join informed consent
Sites / Locations
- 54 Xianlie Rd
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
intervention group
control group
Arm Description
view a 10-minute informational video about comprehensive eye examination
No intervention
Outcomes
Primary Outcome Measures
The acceptance rate of comprehensive eye examination in both groups
acceptance rate of comprehensive eye examination
Secondary Outcome Measures
knowledges of eye disease and attitude of eye examination
knowledges of eye disease and attitude of eye examination
Full Information
NCT ID
NCT01743781
First Posted
November 21, 2012
Last Updated
January 3, 2014
Sponsor
Sun Yat-sen University
Collaborators
Orbis, The World Diabetes Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01743781
Brief Title
Uptake of Comprehensive Eye Examination Trial
Official Title
The Impact of Multimedia Education on Uptake of Comprehensive Eye Examination in Rural Southern China:A Randomized, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
Orbis, The World Diabetes Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate a educational intervention promoting acceptance of comprehensive eye examination in rural Guangdong.
To evaluate the impact of acceptance of comprehensive eye examination in rural Guangdong.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Diabetic Retinopathy
Keywords
comprehensive eye examination, acceptance, glaucoma, diabetic retinopathy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
459 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention group
Arm Type
Experimental
Arm Description
view a 10-minute informational video about comprehensive eye examination
Arm Title
control group
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Behavioral
Intervention Name(s)
video
Intervention Description
view a 10-minute informational video about comprehensive eye examination
Primary Outcome Measure Information:
Title
The acceptance rate of comprehensive eye examination in both groups
Description
acceptance rate of comprehensive eye examination
Time Frame
1 day
Secondary Outcome Measure Information:
Title
knowledges of eye disease and attitude of eye examination
Description
knowledges of eye disease and attitude of eye examination
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age ≥40 years who have never had a comprehensive eye examination
Exclusion Criteria:
inability to join informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathan Congdon, MD,MPH
Organizational Affiliation
Sun yat-sen university, Zhongshan Ophthalmic Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mingguang He, MD,PHD
Organizational Affiliation
Sun Yat-sen University,Zhongshan Ophthalmic Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aihua Dan, MD
Organizational Affiliation
Sun Yat-sen University,Zhongshan Ophthalmic Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
54 Xianlie Rd
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
26218111
Citation
Dan A, Raubvogel G, Chen T, Ye T, Jin L, Xiao B, Sanchez A, Congdon N. The Impact of Multimedia Education on Uptake of Comprehensive Eye Examinations in Rural China: A Randomized, Controlled Trial. Ophthalmic Epidemiol. 2015;22(4):283-90. doi: 10.3109/09286586.2015.1056812.
Results Reference
derived
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Uptake of Comprehensive Eye Examination Trial
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