Western Province Diabetic Retinopathy Screening Project (WPDRSP)

Not Applicable

Completed

• Conditions: Status of the diabetic retinopathy among the diagnosed people with diabetes at a tertiary level medical clinic; Eye Diseases

• Registration Number: ISRCTN47559703
• Lead Sponsor: Commonwealth Eye Health Consortium

Brief Summary

2018 Protocol article in https://dx.doi.org/10.2196/10900 protocol 2019 Results article in https://pubmed.ncbi.nlm.nih.gov/30961576/ (added 24/09/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-08-01
• Study Start: 2019-03-18
• Last Update Posted: 4 October 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

1. Diabetes (PwDM)
2. > 18 years of age

Exclusion Criteria

1. Previous diabetic retinopathy screening and treatment.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Diagnostic test accuracy (sensitivity and specificity) of detecting a defined level of diabetic retinopathy by a physician grader, by comparison with the diagnosis by a specialist retinologist (to take place up to a maximum of 4 weeks after the physician diagnostic test.

Secondary Outcome Measures

Name	Time	Method
1. Other measures of diagnostic test accuracy of detecting a defined level of diabetic retinopathy by the physician graders - 1) negative predictive value, 2) positive predictive value), AND agreement analysis (k-Kappa).