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OpenTrials
Completed

NCT Number: NCT04701931

OCT Angiography Software Evaluation Study

Comparisons for vascular structure visualization in the retina and choroid.

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Key information

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Orange County Retina Medical Group, Santa Ana, California, United States

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Pathology Population Inclusion Criteria

  • 22 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)
  • 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
  • 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

  • 22 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
  • BCVA 20/40 or better in the study eye Exclusion Criteria
  • 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

Treatment and study plan

Maestro2 OCTA

Device

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

Cirrus HD-OCT 5000

Device

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

TRC-50DX

Device

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

Primary outcomes

  1. OCTA image quality

    Time frame: Day 1

    The OCTA image quality comparison between Maestro2 and Cirrus

  2. Visibility of key anatomical vascular features

    Time frame: Day 1

    The OCTA visibility comparison between Maestro2 and Cirrus

  3. 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

Sponsors and collaborators

Lead sponsor

Topcon Corporation

Industry

Registry information

Official study title

Topcon Maestro2 OCT Angiography Software Evaluation Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jan 8, 2021
Registry last updated
Jul 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.