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

M

Ministry of Health, Thailand

Status

Completed

Conditions

Diabetic Retinopathy

Treatments

Device: Digital retina image
Device: direct ophthalmoscopy
Procedure: comprehensive eye exam

Study type

Interventional

Funder types

Other

Identifiers

NCT00500097
0321/1874

Details and patient eligibility

About

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.

Full 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.

Enrollment

840 patients

Sex

All

Ages

15 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Screening

Allocation

Non-Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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