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

July 27, 2007 updated by: Ministry of Health, Thailand

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.

Study Overview

Status

Completed

Conditions

Diabetic Retinopathy

Intervention / Treatment

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

Enrollment (Actual)

840

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Thailand
- - Bangkok, Thailand, 11120
    - Department of Ophthalmology, Rajavithi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Interventional Model: Factorial Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Sensitivity, specificity, kappa coefficient Time Frame: cross-sectional	cross-sectional

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ministry of Health, Thailand

Investigators

Principal Investigator: Paisan Ruamviboonsuk, MD, Department of Ophthalmology, Rajavithi Hospital, Bangkok, Thailand 10400

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

July 11, 2007

First Submitted That Met QC Criteria