OCT Angiography Software Evaluation Study

Completed

• Conditions: Retina Condition Followed by Fluorescein Angiography Imaging
• Interventions: Device: Maestro2 OCTA; Device: Cirrus HD-OCT 5000; Device: TRC-50DX

• Registration Number: NCT04701931
• Lead Sponsor: Topcon Corporation

Brief Summary

Comparisons for vascular structure visualization in the retina and choroid.

Detailed Description

Evaluate the clinical performance of the Maestro2 OCTA for the visualization of the vascular structures of the retina and choroid.

Study Timeline

• Study First Submitted: 2021-01-06
• Study First Submitted QC: 2021-01-06
• Study Start: 2021-01-07
• Study First Posted: 2021-01-08
• Primary Completion: 2022-11-09
• Status Verified: 2023-01
• Study Completion: 2023-06-06
• Last Update Submitted: 2023-07-03
• Last Update Posted: 2023-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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 Maestro2 OCT, 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 Maestro2 OCT, Zeiss Cirrus HD-OCT 5000, and TRC-50DX
Subjects with retinal pathology present in the eye	TRC-50DX	Subjects with no known ocular diseases will be imaged on the Maestro2 OCT, Zeiss Cirrus HD-OCT 5000, and TRC-50DX
Subjects with retinal pathology present in the eye	Cirrus HD-OCT 5000	Subjects with no known ocular diseases will be imaged on the Maestro2 OCT, Zeiss Cirrus HD-OCT 5000, and TRC-50DX
Subjects presenting with Normal Eyes	Maestro2 OCTA	Subjects with no known ocular diseases will be imaged on the Maestro2 OCT, Zeiss Cirrus HD-OCT 5000, and TRC-50DX
Subjects with retinal pathology present in the eye	Maestro2 OCTA	Subjects with no known ocular diseases will be imaged on the Maestro2 OCT, Zeiss Cirrus HD-OCT 5000, and TRC-50DX

Primary Outcome Measures

Name	Time	Method
OCTA image quality	Day 1	The OCTA image quality comparison between Maestro2 and Cirrus
Identification of key pathological vascular features	Day 1	the agreement rate is calculated based on the match outcome is the same between OCTA and FA/ICGA
Visibility of key anatomical vascular features	Day 1	The OCTA visibility comparison between Maestro2 and Cirrus

Trial Locations

Locations (2)

Orange County Retina Medical Group; 🇺🇸 Santa Ana, California, United States

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