Evaluation of Additional Heidelberg Engineering SPECTRALIS With OCT Angiography Module (OCTA Module) Scan Types

Sponsor
Heidelberg Engineering GmbH (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04604002
Collaborator
(none)
60
1
2
11.5
5.2

Study Details

Study Description

Brief Summary

Assessment of image quality and clinical relevance of OCT Angiography at different speed/ART combinations

Condition or Disease Intervention/Treatment Phase
  • Device: OCT Angiography
  • Device: Color Fundus Photography
  • Device: Optical Coherence Tomography
N/A

Detailed Description

The objectives of this study are:

1.) Compare the image quality between the predicate scan types and the corresponding investigational scan types.

  1. Compare the visibility of key anatomical vascular structures between the predicate scan types and the corresponding investigational scan types.

  2. Assess the agreement in identification of vascular abnormalities between the predicate scan types and the corresponding investigational scan types, where agreement is assessed by the vascular abnormalities identified from the predicate scan types.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Diagnostic
Official Title:
Evaluation of Additional Heidelberg Engineering SPECTRALIS With OCT Angiography Module (OCTA Module) Scan Types
Actual Study Start Date :
Oct 15, 2020
Anticipated Primary Completion Date :
Oct 1, 2021
Anticipated Study Completion Date :
Oct 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Subjects with Normal Eyes

OCT, Color Fundus Photography and OCT Angiography as per protocol in subjects without ophthalmic pathology

Device: OCT Angiography
OCT Angiography offers clinicians a non-invasive three-dimensional visualization of vasculature in the retina and choroid. The visualization of perfused vasculature in a three-dimensional layout, offers clinicians an aid in the identification of retinal and choroidal pathologies such as retinal ischemia, microaneurysms, retinal neovascularization and choroidal neovascular membranes.
Other Names:
  • Optical Coherence Tomography Angiography
  • OCTA
  • Device: Color Fundus Photography
    Non-contact white light photography
    Other Names:
  • CFP
  • Device: Optical Coherence Tomography
    A non-contact test that uses light waves to take cross-sectional pictures of the retina
    Other Names:
  • OCT
  • Experimental: Subjects with Pathology

    OCT, Color Fundus Photography and OCT Angiography as per protocol in subjects with retinal vascular pathology

    Device: OCT Angiography
    OCT Angiography offers clinicians a non-invasive three-dimensional visualization of vasculature in the retina and choroid. The visualization of perfused vasculature in a three-dimensional layout, offers clinicians an aid in the identification of retinal and choroidal pathologies such as retinal ischemia, microaneurysms, retinal neovascularization and choroidal neovascular membranes.
    Other Names:
  • Optical Coherence Tomography Angiography
  • OCTA
  • Device: Color Fundus Photography
    Non-contact white light photography
    Other Names:
  • CFP
  • Device: Optical Coherence Tomography
    A non-contact test that uses light waves to take cross-sectional pictures of the retina
    Other Names:
  • OCT
  • Outcome Measures

    Primary Outcome Measures

    1. Image quality score [through study completion, an average of 1 day]

      Graded 0-2 (0 = poor, 1 = average, 2 = good)

    2. Visibility of OCTA key anatomical vascular structures quality score [through study completion, an average of 1 day]

      Graded 0-2 (easy (2), difficult (1) or unable to be distinguished (0)) based on pre-specified abnormalities

    3. Identification of vascular abnormalities on OCTA [through study completion, an average of 1 day]

      Graded Yes, No, or Unable to Grade based on pre-specified abnormalities

    4. Adverse Events [through study completion, an average of 1 day]

      All AEs

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • All Populations:
    1. Able and willing to undergo the test procedures, sign informed consent, and follow instructions.

    2. Age ≥ 22

    • Normal Population:
    1. Subjects without uncontrolled systemic conditions, as determined by the Investigator 4. Subjects without ocular disease, as determined by the Investigator 5. Corrected visual acuity ≥ 20/40 6. No reported history of ocular surgical intervention (except for refractive or cataract surgery)
    • Pathology Population:
    1. Subjects with vascular abnormalities such as retinal ischemia, microaneurysms, choroidal neovascularization, retinal neovascularization in at least one eye
    Exclusion Criteria:
    • All Populations:
    1. Subjects unable to read or write

    2. Subjects with ocular media not sufficiently clear to obtain acceptable study-related imaging

    3. Subjects who cannot tolerate the imaging procedures

    4. Subjects without an accompanying structural OCT and CFP image for an acceptable OCTA image

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Southeast Retina Center Augusta Georgia United States 30909

    Sponsors and Collaborators

    • Heidelberg Engineering GmbH

    Investigators

    • Principal Investigator: Dennis Marcus, MD, Southeast Retina Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Heidelberg Engineering GmbH
    ClinicalTrials.gov Identifier:
    NCT04604002
    Other Study ID Numbers:
    • S-2020-5
    First Posted:
    Oct 27, 2020
    Last Update Posted:
    Aug 6, 2021
    Last Verified:
    Aug 1, 2021
    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

    Study Results

    No Results Posted as of Aug 6, 2021