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

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ClinicalTrials.gov Identifier: NCT04604002
Recruitment Status : Recruiting
First Posted : October 27, 2020
Last Update Posted : October 28, 2020
Sponsor:
Information provided by (Responsible Party):
Heidelberg Engineering GmbH

Tracking Information
First Submitted Date  ICMJE October 20, 2020
First Posted Date  ICMJE October 27, 2020
Last Update Posted Date October 28, 2020
Actual Study Start Date  ICMJE October 15, 2020
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 26, 2020)
  • Image quality score [ Time Frame: through study completion, an average of 1 day ]
    Graded 0-2 (0 = poor, 1 = average, 2 = good)
  • Visibility of OCTA key anatomical vascular structures quality score [ Time Frame: 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
  • Identification of vascular abnormalities on OCTA [ Time Frame: through study completion, an average of 1 day ]
    Graded Yes, No, or Unable to Grade based on pre-specified abnormalities
  • Adverse Events [ Time Frame: through study completion, an average of 1 day ]
    All AEs
Original Primary Outcome Measures  ICMJE
 (submitted: October 26, 2020)
  • Image quality score [ Time Frame: through study completion, an average of 1 day ]
    OCTA
  • Visibility of OCTA key anatomical vascular structures quality score [ Time Frame: through study completion, an average of 1 day ]
    based on pre-specified abnormalities
  • Identification of vascular abnormalities on OCTA [ Time Frame: through study completion, an average of 1 day ]
    based on pre-specified abnormalities
  • Adverse Events [ Time Frame: through study completion, an average of 1 day ]
    All AEs
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Additional Heidelberg Engineering SPECTRALIS With OCT Angiography Module (OCTA Module) Scan Types
Official Title  ICMJE Evaluation of Additional Heidelberg Engineering SPECTRALIS With OCT Angiography Module (OCTA Module) Scan Types
Brief Summary Assessment of image quality and clinical relevance of OCT Angiography at different speed/ART combinations
Detailed Description

The objectives of this study are:

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

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

3. 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Retinal Vascular
  • Normal Eyes
Intervention  ICMJE
  • 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 Name: CFP
  • Device: Optical Coherence Tomography
    A non-contact test that uses light waves to take cross-sectional pictures of the retina
    Other Name: OCT
Study Arms  ICMJE
  • Experimental: Subjects with Normal Eyes
    OCT, Color Fundus Photography and OCT Angiography as per protocol in subjects without ophthalmic pathology
    Interventions:
    • Device: OCT Angiography
    • Device: Color Fundus Photography
    • Device: Optical Coherence Tomography
  • Experimental: Subjects with Pathology
    OCT, Color Fundus Photography and OCT Angiography as per protocol in subjects with retinal vascular pathology
    Interventions:
    • Device: OCT Angiography
    • Device: Color Fundus Photography
    • Device: Optical Coherence Tomography
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 26, 2020)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All Populations:

    1. Able and willing to undergo the test procedures, sign informed consent, and follow instructions.
    2. Age ≥ 22
  • Normal Population:

    3. 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:

    3. 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Heather Oakes 508-570-8553 heather.oakes@heidelbergengineering.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04604002
Other Study ID Numbers  ICMJE S-2020-5
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Heidelberg Engineering GmbH
Study Sponsor  ICMJE Heidelberg Engineering GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dennis Marcus, MD Southeast Retina Center
PRS Account Heidelberg Engineering GmbH
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP