Topcon DRI OCT Triton With SS-OCT Angio Software Evaluation Study

Completed

• Conditions: Fluorescein Angiography Imaging
• Interventions: Device: DRI OCT Triton with SS-OCT Angio software; Device: Cirrus HD-OCT 5000; Device: TRC-50DX

• Registration Number: NCT04201340
• Lead Sponsor: Topcon Corporation

Brief Summary

Comparisons for vascular structure visualization in the retina and choroid.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-11
• Study First Submitted: 2019-12-12
• Study First Submitted QC: 2019-12-13
• Study First Posted: 2019-12-17
• Primary Completion: 2022-07-28
• Study Completion: 2022-10-20
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-06
• Last Update Posted: 2022-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 211

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects Presenting with Normal Eyes	Cirrus HD-OCT 5000	Subjects with no known ocular diseases will be imaged on the DRI OCT Triton with SS-OCT Angio software, Zeiss Cirrus HD-OCT 5000, and TRC-50DX
Subjects with retinal pathology present in the vasculature	TRC-50DX	Subjects with retinal pathology likely to present in the vasculature will be imaged on the DRI OCT Triton with SS-OCT Angio software, Zeiss Cirrus HD-OCT 5000, and TRC-50DX
Subjects Presenting with Normal Eyes	DRI OCT Triton with SS-OCT Angio software	Subjects with no known ocular diseases will be imaged on the DRI OCT Triton with SS-OCT Angio software, Zeiss Cirrus HD-OCT 5000, and TRC-50DX
Subjects Presenting with Normal Eyes	TRC-50DX	Subjects with no known ocular diseases will be imaged on the DRI OCT Triton with SS-OCT Angio software, Zeiss Cirrus HD-OCT 5000, and TRC-50DX
Subjects with retinal pathology present in the vasculature	DRI OCT Triton with SS-OCT Angio software	Subjects with retinal pathology likely to present in the vasculature will be imaged on the DRI OCT Triton with SS-OCT Angio software, Zeiss Cirrus HD-OCT 5000, and TRC-50DX
Subjects with retinal pathology present in the vasculature	Cirrus HD-OCT 5000	Subjects with retinal pathology likely to present in the vasculature will be imaged on the DRI OCT Triton with SS-OCT Angio software, Zeiss Cirrus HD-OCT 5000, and TRC-50DX

Primary Outcome Measures

Name	Time	Method
Negative percent agreement (NPA) for each OCT-A device using TRC-50DX as the reference	Day 1	Comparison of OCT devices to TRC-50DX
Positive percent agreement (PPA) for each OCT-A device using TRC-50DX as the reference	Day 1	Comparison of OCT devices to TRC-50DX
Agreement of pathology identification between the two OCT-A devices	Day 1	Compare the pathology identifications between the OCT-A devices

Secondary Outcome Measures

Name	Time	Method
OCT-A image quality score (poor, average and good)	Day 1	Image quality score

Trial Locations

Locations (1)

Southeast Retina Center; 🇺🇸 Augusta, Georgia, United States