Diabetic Retinopathy and Diabetic Macular Edema Screening by Non-Physicians With Limited Training

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00500097
Recruitment Status : Completed
First Posted : July 12, 2007
Last Update Posted : July 31, 2007
Information provided by:
Ministry of Health, Thailand

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetic Retinopathy Device: Digital retina image Device: direct ophthalmoscopy Procedure: comprehensive eye exam Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 840 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Study Start Date : May 2005
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Sensitivity, specificity, kappa coefficient [ Time Frame: cross-sectional ]

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00500097

Department of Ophthalmology, Rajavithi Hospital
Bangkok, Thailand, 11120
Sponsors and Collaborators
Ministry of Health, Thailand
Principal Investigator: Paisan Ruamviboonsuk, MD Department of Ophthalmology, Rajavithi Hospital, Bangkok, Thailand 10400 Identifier: NCT00500097     History of Changes
Other Study ID Numbers: 0321/1874
First Posted: July 12, 2007    Key Record Dates
Last Update Posted: July 31, 2007
Last Verified: July 2007

Additional relevant MeSH terms:
Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases