- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00500097
Diabetic Retinopathy and Diabetic Macular Edema Screening by Non-Physicians With Limited Training
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Diabetic visual disabilities have increasingly become a global concern since a number of diabetic patients are expected to surge dramatically in the coming decade. Essential means to minimize this problem are detecting vision-threatening diabetic retinopathy early in the course of disease and timely interventions by ophthalmologists.
The American Diabetes Association had issued a guideline for the detection and recommended regular comprehensive eye examination as a preferred method. However, it is not likely that there will be ophthalmologists enough to comprehensively examine the surging number of diabetic patients. Other practical screening methods, such as an interpretation of digital retinal images or direct ophthalmoscopy employed by other health care providers, for identifying the retinopathy for referral to ophthalmologists, should minimize this problem.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Bangkok, Thailand, 11120
- Department of Ophthalmology, Rajavithi Hospital
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- diabetic patients defined by WHO criteria
- lived in the geographic area of participated hospitals
Exclusion Criteria:
- have contraindications for receiving mydriatic medications
- have ocular media not clear enough for making diagnosis by any of the screening equipment
- have other retina diseases precluded the diagnosis of diabetic retinopathy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Sensitivity, specificity, kappa coefficient
Time Frame: cross-sectional
|
cross-sectional
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Paisan Ruamviboonsuk, MD, Department of Ophthalmology, Rajavithi Hospital, Bangkok, Thailand 10400
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0321/1874
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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