OCT Angiography Software Evaluation Study

NCT04701931 | Completed FDA Device

• 1 other identifier: THS-TPCN-2020-003
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 2

Brief Summary

Comparisons for vascular structure visualization in the retina and choroid.

Conditions

Retina Condition Followed by Fluorescein Angiography Imaging

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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: Maestro2 OCTA; Device: Cirrus HD-OCT 5000; Device: TRC-50DX

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: Maestro2 OCTA; Device: Cirrus HD-OCT 5000; Device: TRC-50DX

Interventions

Maestro2 OCTA DEVICE

The Maestro2 OCTA with SS-OCT Angio software is an OCT with a fundus camera used for diagnostic purposes

Subjects presenting with Normal Eyes; Subjects with retinal pathology present in the eye

Cirrus HD-OCT 5000 DEVICE

The Zeiss Cirrus HD-OCT 5000 is an OCT used for diagnostic purposes

Subjects presenting with Normal Eyes; Subjects with retinal pathology present in the eye

TRC-50DX DEVICE

The TRC-50DX retinal camera images the fundus used for diagnostic purposes

Subjects presenting with Normal Eyes; Subjects with retinal pathology present in the eye

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Population with normal eye or eyes with pathology

You may qualify if:

• years of age or older on the date of informed consent
• Able to understand the written informed consent and willing to participate by signing the informed consent
• Current diagnosis of one or more of the following pathologies in the study eye in two subgroups:
• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Topcon Corporation: lead

Study Sites (2)

Orange County Retina Medical Group

Santa Ana, California, 92705, United States

Location

Southeast Retina Center

Augusta, Georgia, 30909, United States

Location

Study Officials

• Mayra Tafreshi

  CPAD

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: January 8, 2021
• Study Start: January 7, 2021
• Primary Completion: November 9, 2022
• Study Completion: June 6, 2023
• Last Updated: July 5, 2023

Record last verified: 2023-01

Locations

US (2)