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Sponsored by: |
Ministry of Health, Thailand |
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Information provided by: | Ministry of Health, Thailand |
ClinicalTrials.gov Identifier: | NCT00500097 |
The purpose is to assess accuracy of digital retinal image interpretation by technicians and direct ophthalmoscopy by nurses for the determination of diabetic retinopathy severity and the presence of diabetic macular edema for the identification of referrals to ophthalmologists. The results of both screening methods were compared with comprehensive eye examination by ophthalmologists.
Condition | Intervention |
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Diabetic Retinopathy |
Device: Digital retina image Device: direct ophthalmoscopy Procedure: comprehensive eye exam |
Study Type: | Interventional |
Study Design: | Screening, Non-Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study |
Enrollment: | 840 |
Study Start Date: | May 2005 |
Study Completion Date: | June 2006 |
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.
Ages Eligible for Study: | 15 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Thailand | |
Department of Ophthalmology, Rajavithi Hospital | |
Bangkok, Thailand, 11120 |
Principal Investigator: | Paisan Ruamviboonsuk, MD | Department of Ophthalmology, Rajavithi Hospital, Bangkok, Thailand 10400 |
Study ID Numbers: | 0321/1874 |
Study First Received: | July 11, 2007 |
Last Updated: | July 27, 2007 |
ClinicalTrials.gov Identifier: | NCT00500097 |
Health Authority: | Thailand: Ministry of Public Health |
Macular Edema Diabetic Retinopathy Eye Diseases Diabetes Mellitus Vascular Diseases Endocrine System Diseases |
Edema Endocrinopathy Diabetes Complications Retinal Diseases Diabetic Angiopathies |
Cardiovascular Diseases |