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NCT00500097 Clinical Trial

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

Diabetic Retinopathy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00500097
Other study ID # 0321/1874
Secondary ID
Status Completed
Phase N/A
First received July 11, 2007
Last updated July 27, 2007
Start date May 2005
Est. completion date June 2006

Study information
Verified date July 2007
Source Ministry of Health, Thailand
Contact n/a
Is FDA regulated No
Health authority Thailand: Ministry of Public Health
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 840
Est. completion date June 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 15 Years to 80 Years
Eligibility 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

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

Related Conditions & MeSH terms

Intervention

Device:
• Digital retina image

• direct ophthalmoscopy

Procedure:
• comprehensive eye exam

Locations
Country Name City State
Thailand Department of Ophthalmology, Rajavithi Hospital Bangkok

Sponsors (1)
Lead Sponsor Collaborator
Ministry of Health, Thailand

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sensitivity, specificity, kappa coefficient cross-sectional
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