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Diabetic Retinopathy and Diabetic Macular Edema Screening by Non-Physicians With Limited Training
This study has been completed.
Sponsored by: Ministry of Health, Thailand
Information provided by: Ministry of Health, Thailand
ClinicalTrials.gov Identifier: NCT00500097
  Purpose

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

MedlinePlus related topics: Diabetic Eye Problems Edema Retinal Disorders
U.S. FDA Resources
Study Type: Interventional
Study Design: Screening, Non-Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study

Further study details as provided by Ministry of Health, Thailand:

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

Enrollment: 840
Study Start Date: May 2005
Study Completion Date: June 2006
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.

  Eligibility

Ages Eligible for Study:   15 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00500097

Locations
Thailand
Department of Ophthalmology, Rajavithi Hospital
Bangkok, Thailand, 11120
Sponsors and Collaborators
Ministry of Health, Thailand
Investigators
Principal Investigator: Paisan Ruamviboonsuk, MD Department of Ophthalmology, Rajavithi Hospital, Bangkok, Thailand 10400
  More Information

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

Study placed in the following topic categories:
Macular Edema
Diabetic Retinopathy
Eye Diseases
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases
Edema
Endocrinopathy
Diabetes Complications
Retinal Diseases
Diabetic Angiopathies

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009