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

Not Applicable

Completed

• Conditions: Diabetic Retinopathy

• Registration Number: NCT00500097
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2005-05
• Study Completion: 2006-06
• Status Verified: 2007-07
• Study First Submitted: 2007-07-11
• Study First Submitted QC: 2007-07-11
• Study First Posted: 2007-07-12
• Last Update Submitted: 2007-07-27
• Last Update Posted: 2007-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 840

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Sensitivity, specificity, kappa coefficient	cross-sectional

Trial Locations

Locations (1)

Department of Ophthalmology, Rajavithi Hospital; 🇹🇭 Bangkok, Thailand