Skip to main content
OpenTrials
Completed

NCT Number: NCT00500097

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

15 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Ophthalmology, Rajavithi Hospital

Bangkok, 11120, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Digital retina image

Device

direct ophthalmoscopy

Device

comprehensive eye exam

Procedure

Primary outcomes

  1. Sensitivity, specificity, kappa coefficient

    Time frame: cross-sectional

Sponsors and collaborators

Lead sponsor

Ministry of Health, Thailand

Other Gov

Registry information

Important dates

Study start
2005
Study completion
2006
First posted
Jul 12, 2007
Registry last updated
Jul 31, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.