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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

840 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2006-06-30

Brief Summary

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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

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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.

Conditions

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Diabetic Retinopathy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Interventions

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Digital retina image

Intervention Type DEVICE

direct ophthalmoscopy

Intervention Type DEVICE

comprehensive eye exam

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

15 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Paisan Ruamviboonsuk, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Ophthalmology, Rajavithi Hospital, Bangkok, Thailand 10400

Locations

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Department of Ophthalmology, Rajavithi Hospital

Bangkok, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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0321/1874

Identifier Type: -

Identifier Source: org_study_id