Skip to content

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00500097
Enrollment
840
Registered
2007-07-12
Start date
2005-05-31
Completion date
2006-06-30
Last updated
2007-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Retinopathy

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.

Interventions

DEVICEDigital retina image
DEVICEdirect ophthalmoscopy

Sponsors

Ministry of Health, Thailand
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Sensitivity, specificity, kappa coefficientcross-sectional

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026