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CompletedNCT04701931Updated Jul 5, 2023

OCT Angiography Software Evaluation Study

An observational study in Retina Condition Followed by Fluorescein Angiography Imaging, sponsored by Topcon Corporation. Completed at 2 sites in United States. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-05.

Sponsored by Topcon Corporation · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
135
Ages
22 Years and older
Sex
All
01

Study summary

Comparisons for vascular structure visualization in the retina and choroid.

Read the detailed description

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

02

Conditions studied

  • Retina Condition Followed by Fluorescein Angiography Imaging
03

In context

Lead sponsor

Topcon Corporation is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Population with normal eye or eyes with pathology

Eligibility criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
135 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • DeviceMaestro2 OCTA

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

  • DeviceCirrus HD-OCT 5000

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

  • DeviceTRC-50DX

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

06

What researchers measure

Primary outcomes

  1. OCTA image quality

    The OCTA image quality comparison between Maestro2 and Cirrus

    Time frame: Day 1

  2. Visibility of key anatomical vascular features

    The OCTA visibility comparison between Maestro2 and Cirrus

    Time frame: Day 1

  3. Identification of key pathological vascular features

    the agreement rate is calculated based on the match outcome is the same between OCTA and FA/ICGA

    Time frame: Day 1

07

Study locations

2 sites
  • Orange County Retina Medical Group
    Santa Ana, California 92705, United States
  • Southeast Retina Center
    Augusta, Georgia 30909, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04701931
Lead sponsor
Topcon Corporation
Responsible party
Sponsor
First posted
Jan 8, 2021
Start date
Jan 7, 2021
Primary completion
Nov 9, 2022
Completion
Jun 6, 2023
Last update
Jul 5, 2023

Study contacts

Mayra Tafreshi
study director · CPAD

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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