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Status:

COMPLETED

OCT Angiography Software Evaluation Study

Lead Sponsor:

Topcon Corporation

Conditions:

Retina Condition Followed by Fluorescein Angiography Imaging

Eligibility:

All Genders

22+ years

Brief Summary

Comparisons for vascular structure visualization in the retina and choroid.

Detailed Description

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

Eligibility Criteria

Inclusion

  • 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
  • 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
  • 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
  • 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

Exclusion

    Key Trial Info

    Start Date :

    January 7 2021

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    June 6 2023

    Estimated Enrollment :

    135 Patients enrolled

    Trial Details

    Trial ID

    NCT04701931

    Start Date

    January 7 2021

    End Date

    June 6 2023

    Last Update

    July 5 2023

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    Orange County Retina Medical Group

    Santa Ana, California, United States, 92705

    2

    Southeast Retina Center

    Augusta, Georgia, United States, 30909