OCT Angiography Software Evaluation Study

Topcon Maestro2 OCT Angiography Software Evaluation Study

Comparisons for vascular structure visualization in the retina and choroid.

Study Overview

• Status: Completed
• Conditions: Retina Condition Followed by Fluorescein Angiography Imaging
• Intervention / Treatment: Device: Cirrus HD-OCT 5000; Device: TRC-50DX; Device: Maestro2 OCTA

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 135

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Ana, California, United States, 92705
      • Orange County Retina Medical Group
  • Georgia
    • Augusta, Georgia, United States, 30909
      • Southeast Retina Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Population with normal eye or eyes with pathology

Description

Pathology Population Inclusion Criteria

1. 22 years of age or older on the date of informed consent
2. Able to understand the written informed consent and willing to participate by signing the informed consent

3. Current diagnosis of one or more of the following pathologies in the study eye in two subgroups:

   1. Vascular pathologies primarily visualized in Superficial and Deep en face OCTA slabs, including but not limited to Diabetic Retinopathy (DR), Branch Retinal Vein Occlusion (BRVO), Central Retinal Vein Occlusion (CRVO), Central Retinal Arterial Occlusion (CRAO), Macular Telangiectasia (MacTel), Sickle Cell Retinopathy (SCR)
   2. Vascular pathologies primarily visualized in Outer Retina and Choriocapillaris en face OCTA slabs, including but not limited to Neovascular Age-Related Macular Degeneration ("wet" AMD) and Polypoidal Choroidal Vasculopathy (PCV) Exclusion Criteria

1. Subjects previously enrolled in Maestro2 OCTA feasibility study 2. Subjects who are pregnant or lactating* 3. Unable to complete the required clinical examinations 4. Contraindication to pupil dilation 6. Known allergy or other contradictions to fluorescein and/or to indocyanine green or iodides

Normal Population Inclusion Criteria

1. 22 years of age or older on the date of informed consent
2. Able to understand the written informed consent and willing to participate by signing the informed consent
3. BCVA 20/40 or better in the study eye Exclusion Criteria

1. Subjects previously enrolled in Maestro2 OCTA feasibility study 2. Subjects who are pregnant or lactating* 3. Unable to complete the required clinical examinations 4. Clinically significant findings in the study eye in clinical examination 5. Contraindication to pupil dilation 7. Known allergy or contradictions to fluorescein and/or to indocyanine green or iodides

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subjects presenting with Normal Eyes; Subjects with no known ocular diseases will be imaged on the Maestro2 OCT, Zeiss Cirrus HD-OCT 5000, and TRC-50DX	Device: Cirrus HD-OCT 5000; The Zeiss Cirrus HD-OCT 5000 is an OCT used for diagnostic purposes; Device: TRC-50DX; The TRC-50DX retinal camera images the fundus used for diagnostic purposes; Device: Maestro2 OCTA; The Maestro2 OCTA with SS-OCT Angio software is an OCT with a fundus camera used for diagnostic purposes
Subjects with retinal pathology present in the eye; Subjects with no known ocular diseases will be imaged on the Maestro2 OCT, Zeiss Cirrus HD-OCT 5000, and TRC-50DX	Device: Cirrus HD-OCT 5000; The Zeiss Cirrus HD-OCT 5000 is an OCT used for diagnostic purposes; Device: TRC-50DX; The TRC-50DX retinal camera images the fundus used for diagnostic purposes; Device: Maestro2 OCTA; The Maestro2 OCTA with SS-OCT Angio software is an OCT with a fundus camera used for diagnostic purposes

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Topcon Corporation
• Investigators: Study Director: Mayra Tafreshi, CPAD

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2021
• Primary Completion (Actual): November 9, 2022
• Study Completion (Actual): June 6, 2023

Study Registration Dates

• First Submitted: January 6, 2021
• First Submitted That Met QC Criteria: January 6, 2021
• First Posted (Actual): January 8, 2021

Study Record Updates

• Last Update Posted (Actual): July 5, 2023
• Last Update Submitted That Met QC Criteria: July 3, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: THS-TPCN-2020-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No