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

Primary Purpose

Diabetic Retinopathy

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Digital retina image
direct ophthalmoscopy
comprehensive eye exam
Sponsored by
Ministry of Health, Thailand
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional screening trial for Diabetic Retinopathy

Eligibility Criteria

15 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Ophthalmology, Rajavithi Hospital

Outcomes

Primary Outcome Measures

Sensitivity, specificity, kappa coefficient

Secondary Outcome Measures

Full Information

First Posted
July 11, 2007
Last Updated
July 27, 2007
Sponsor
Ministry of Health, Thailand
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1. Study Identification

Unique Protocol Identification Number
NCT00500097
Brief Title
Diabetic Retinopathy and Diabetic Macular Edema Screening by Non-Physicians With Limited Training
Study Type
Interventional

2. Study Status

Record Verification Date
July 2007
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ministry of Health, Thailand

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
840 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Digital retina image
Intervention Type
Device
Intervention Name(s)
direct ophthalmoscopy
Intervention Type
Procedure
Intervention Name(s)
comprehensive eye exam
Primary Outcome Measure Information:
Title
Sensitivity, specificity, kappa coefficient
Time Frame
cross-sectional

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paisan Ruamviboonsuk, MD
Organizational Affiliation
Department of Ophthalmology, Rajavithi Hospital, Bangkok, Thailand 10400
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmology, Rajavithi Hospital
City
Bangkok
ZIP/Postal Code
11120
Country
Thailand

12. IPD Sharing Statement

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

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