NCT00500097

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
840

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 12, 2007

Completed
Last Updated

July 31, 2007

Status Verified

July 1, 2007

First QC Date

July 11, 2007

Last Update Submit

July 27, 2007

Conditions

Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

  • Sensitivity, specificity, kappa coefficient

    cross-sectional

Interventions

Digital retina imageDEVICE
direct ophthalmoscopyDEVICE
comprehensive eye examPROCEDURE

Eligibility Criteria

Age15 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • diabetic patients defined by WHO criteria
  • lived in the geographic area of participated hospitals

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, Rajavithi Hospital

Bangkok, 11120, Thailand

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

Ophthalmoscopy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, OphthalmologicalDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Paisan Ruamviboonsuk, MD

    Department of Ophthalmology, Rajavithi Hospital, Bangkok, Thailand 10400

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
FACTORIAL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 11, 2007

First Posted

July 12, 2007

Study Start

May 1, 2005

Study Completion

June 1, 2006

Last Updated

July 31, 2007

Record last verified: 2007-07

Locations

TH(1)