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Evaluation of the Repeatability and Reproducibility of OCTA Image Quality With the Heidelberg Engineering SPECTRALIS With OCT Angiography Module

Sponsor
Heidelberg Engineering GmbH (Industry)
Overall Status
Terminated
CT.gov ID
NCT03530449
Collaborator
(none)
39
Enrollment
1
Location
4.5
Actual Duration (Months)
8.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Repeatability and Reproducibility of OCTA Image Quality with the Heidelberg Engineering SPECTRALIS

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

Detailed Description

The objectives of this study are to:

  1. Assess the repeatability and reproducibility of the SPECTRALIS with OCTA Module image quality

  2. Assess the repeatability and reproducibility of visibility of key anatomical vascular structures in the SPECTRALIS with OCTA Module

Study Design

Study Type:
Observational
Actual Enrollment :
39 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation of the Repeatability and Reproducibility of OCTA Image Quality With the Heidelberg Engineering SPECTRALIS With OCT Angiography Module
Actual Study Start Date :
Apr 30, 2018
Actual Primary Completion Date :
Sep 15, 2018
Actual Study Completion Date :
Sep 15, 2018

Arms and Interventions

Arm Intervention/Treatment
Subjects with Normal Eyes

Color Fundus Photography, Optical Coherence Tomography, and OCT Angiography scans 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:
  • OCTA

    • Device: Color Fundus Photography
    Non-contact white light photography
    Other Names:
  • CFP

    • Device: Optical Coherence Tomography
    Two and Three dimensional cross sectional imaging of the back of the eye to look at vascular structures and is an aid in the detection and management of various ocular diseases.
    Other Names:
  • Structural OCT
  • OCT

    		•
    Subjects with Retinal Vascular Pathology

    Color Fundus Photography, Optical Coherence Tomography, and OCT Angiography scans as per protocol in subjects with retinal vascular 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:
  • OCTA

    • Device: Color Fundus Photography
    Non-contact white light photography
    Other Names:
  • CFP

    • Device: Optical Coherence Tomography
    Two and Three dimensional cross sectional imaging of the back of the eye to look at vascular structures and is an aid in the detection and management of various ocular diseases.
    Other Names:
  • Structural OCT
  • OCT

    		•

    Outcome Measures

    Primary Outcome Measures

    1. OCTA image quality [day 1]

      Image quality grading results of study selected images

    2. Visualization of key anatomical vascular structures on OCTA [day 1]

      Grading of visibility of key anatomical vascular structures of study selected images

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • All subjects: Able and willing to undergo the test procedures, sign informed consent, and follow instructions.

    • Age ≥ 22

    Subjects with Normal Eyes:
    • Corrected visual acuity ≥ 20/40 in each eye
    Subjects with Pathology:

    • Subjects with vascular retinal conditions in at least one eye

    • Subjects included should have a range of retinal vascular pathologies likely to appear in OCTA imaging, affecting different anatomic depths through the retina and choroid. Retinal conditions including but not limited to diabetic retinopathy, wet age-related macular degeneration (AMD), and branch or central retinal vein occlusion that give rise to features such as retinal ischemia, microaneurysms, choroidal neovascularization and retinal neovascularization will be included.

    Exclusion Criteria:

    • All Subjects:

    • Subjects unable to read or write

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

    • Subjects who cannot tolerate the imaging procedures

    • Subjects with contraindication to pupillary dilation in the study eye

    • Subjects with Normal Eyes:

    • Subjects with uncontrolled systemic conditions, or ocular disease, as determined by the Investigator, during the eye exam and CFP

    • History of ocular surgical intervention (except for refractive or cataract surgery) in either eye

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 State University of New York College of Optometry (SUNY) New York New York United States 10036

    Sponsors and Collaborators

    • Heidelberg Engineering GmbH

    Investigators

    • Principal Investigator: Mitchell W Dul, OD, State University of New York College of Optometry

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Heidelberg Engineering GmbH
    ClinicalTrials.gov Identifier:
    NCT03530449
    Other Study ID Numbers:
    • S-2018-1
    First Posted:
    May 21, 2018
    Last Update Posted:
    Feb 28, 2019
    Last Verified:
    Feb 1, 2019
    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 Feb 28, 2019