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Evaluation of Heidelberg Engineering SPECTRALIS With OCT Angiography Module

Sponsor
Heidelberg Engineering GmbH (Industry)
Overall Status
Completed
CT.gov ID
NCT03279939
Collaborator
(none)
95
Enrollment
1
Location
2
Arms
4.7
Actual Duration (Months)
20.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Assessment of image quality and clinical relevance of OCT Angiography via comparison to FA/ICGA.

Condition or Disease Intervention/Treatment Phase
  • Device: OCT Angiography
  • Device: Color Fundus Photography
  • Device: Fluorescein Angiography
  • Device: Indocyaine Green Angiography
 N/A

Detailed Description

The objectives of this study are:

  1. To compare the OCTA image quality between the SPECTRALIS and the predicate.

  2. To compare the agreement of clinical findings on SPECTRALIS OCTA to the predicate.

Study Design

Study Type:
Interventional
Actual Enrollment :
95 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Diagnostic
Official Title:
Evaluation of Heidelberg Engineering SPECTRALIS With OCT Angiography Module
Actual Study Start Date :
Aug 23, 2017
Actual Primary Completion Date :
Jan 12, 2018
Actual Study Completion Date :
Jan 12, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Subjects with Normal Eyes

OCT Angiography, Color Fundus Photography, and Fluorescein 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:
  • OCTA

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

    • Device: Fluorescein Angiography
    An imaging procedure where dye is injected into a vein and images are taken of the back of the eye to visualize the perfusion of retinal vessels in two dimensional images.
    Other Names:
  • FA

    		•
    Experimental: Subjects with Pathology

    OCT Angiography, Color Fundus Photography, Fluorescein Angiography, and when clinically indicated, Indocyaine Green 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:
  • OCTA

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

    • Device: Fluorescein Angiography
    An imaging procedure where dye is injected into a vein and images are taken of the back of the eye to visualize the perfusion of retinal vessels in two dimensional images.
    Other Names:
  • FA

    • Device: Indocyaine Green Angiography
    An imaging procedure where dye is injected into a vein and images are taken of the back of the eye to visualize the perfusion of choroidal vessels in two dimensional images.
    Other Names:
  • ICGA

    		•

    Outcome Measures

    Primary Outcome Measures

    1. OCTA image quality [day 1]

      Image quality grading results of study selected images

    2. Clinically relevant findings on OCTA [day 1]

      Clinically relevant grading results 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:

    • Subjects presenting at the site without uncontrolled systemic conditions, or ocular disease, as determined by the Investigator

    • Corrected visual acuity ≥ 20/40 in each eye

    • No history of ocular surgical intervention (except for refractive or cataract surgery) in either eye

    Subjects with Pathology:

    • Subjects with retinal conditions in at least one eye.

    • Subjects included can have a range of retinal vascular pathologies 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:

    • 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 known allergies to fluorescein dye, Indocyanine Green (ICG), shellfish, drugs for pupillary dilation

    • Subjects with contraindication to pupillary dilation in study eye

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Retina Consultants of Houston Houston Texas United States 77030

    Sponsors and Collaborators

    • Heidelberg Engineering GmbH

    Investigators

    • Principal Investigator: David Brown, MD, Retina Consultants Houston

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Heidelberg Engineering GmbH
    ClinicalTrials.gov Identifier:
    NCT03279939
    Other Study ID Numbers:
    • S-2017-1
    First Posted:
    Sep 12, 2017
    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