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

This study has been completed.
Sponsor:
Information provided by:
Ministry of Health, Thailand
ClinicalTrials.gov Identifier:
NCT00500097
First received: July 11, 2007
Last updated: July 27, 2007
Last verified: July 2007
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Screening

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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:
Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 18, 2014