Diabetic Retinopathy and Diabetic Macular Edema Screening by Non-Physicians With Limited Training
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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 |
---|---|
Diabetic Retinopathy |
Device: Digital retina image Device: direct ophthalmoscopy Procedure: comprehensive eye exam |
Study Type: | Interventional |
Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Screening |
- Sensitivity, specificity, kappa coefficient [ Time Frame: cross-sectional ]
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.
![](https://webarchive.library.unt.edu/web/20121019083436im_/http://www.clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 15 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
![](https://webarchive.library.unt.edu/web/20121019083436im_/http://www.clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Thailand | |
Department of Ophthalmology, Rajavithi Hospital | |
Bangkok, Thailand, 11120 |
Principal Investigator: | Paisan Ruamviboonsuk, MD | Department of Ophthalmology, Rajavithi Hospital, Bangkok, Thailand 10400 |
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No publications provided
ClinicalTrials.gov Identifier: | NCT00500097 History of Changes |
Other Study ID Numbers: | 0321/1874 |
Study First Received: | July 11, 2007 |
Last Updated: | July 27, 2007 |
Health Authority: | Thailand: Ministry of Public Health |
Additional relevant MeSH terms:
Diabetic Retinopathy Retinal Diseases Eye Diseases Diabetic Angiopathies Vascular Diseases |
Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases |
ClinicalTrials.gov processed this record on October 17, 2012