Comparison of the Optos 200Tx non-mydriatic fundus camera and the Topcon TRC-50DX camera for diabetic retinopathy evaluatio

Completed

• Conditions: diabetes mellitus; 10047061

• Registration Number: NL-OMON35208
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

We are particularly interested in patients without diabetic retinopathy (DRP) (n=30) and patients with minimal changes due to DRP (micro-aneurysms and other small lesions) (n=30). If the quality of the
pictures is good enough to spot these small lesions, it will also be good enough to
spot larger abnormalities.

Exclusion Criteria

Age below 18 years. Absence of informed consent

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameter/endpoint<br /><br>The number of diabetic lesions found on the Optos 200Tx photographs taken in<br /><br>miosis, on the Optos 200Tx photographs taken in mydriasis, and on the<br /><br>photographs made with the current camera in mydriasis.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters/endpoints<br /><br>A forced choice subjective ranking of the image quality of paired Optos<br /><br>pictures:<br /><br>miosis versus mydriasis.</p><br>