OCT Angiography Software Evaluation Study

July 3, 2023 updated by: Topcon Corporation

Topcon Maestro2 OCT Angiography Software Evaluation Study

Comparisons for vascular structure visualization in the retina and choroid.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
135

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
OCTA image quality
Time Frame: Day 1
The OCTA image quality comparison between Maestro2 and Cirrus
Day 1
Visibility of key anatomical vascular features
Time Frame: Day 1
The OCTA visibility comparison between Maestro2 and Cirrus
Day 1
Identification of key pathological vascular features
Time Frame: Day 1
the agreement rate is calculated based on the match outcome is the same between OCTA and FA/ICGA
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Topcon Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Mayra Tafreshi, CPAD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 7, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 9, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 6, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 6, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 5, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

Rare Diseases

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Dietary Supplements

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