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Evaluation of Heidelberg Engineering SPECTRALIS With OCT Angiography Module

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03279939
Recruitment Status : Completed
First Posted : September 12, 2017
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
Heidelberg Engineering GmbH

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

Condition or disease Intervention/treatment Phase
Retinal Vascular Normal Eyes Device: OCT Angiography Device: Color Fundus Photography Device: Fluorescein Angiography Device: Indocyaine Green Angiography Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : August 23, 2017
Actual Primary Completion Date : January 12, 2018
Actual Study Completion Date : January 12, 2018

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 Name: OCTA

Device: Color Fundus Photography
Non-contact white light photography.
Other Name: 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 Name: 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 Name: OCTA

Device: Color Fundus Photography
Non-contact white light photography.
Other Name: 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 Name: 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 Name: ICGA




Primary Outcome Measures :
  1. OCTA image quality [ Time Frame: day 1 ]
    Image quality grading results of study selected images

  2. Clinically relevant findings on OCTA [ Time Frame: day 1 ]
    Clinically relevant grading results of study selected images



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03279939


Locations
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United States, Texas
Retina Consultants of Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
Heidelberg Engineering GmbH
Investigators
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Principal Investigator: David Brown, MD Retina Consultants Houston
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Responsible Party: Heidelberg Engineering GmbH
ClinicalTrials.gov Identifier: NCT03279939    
Other Study ID Numbers: S-2017-1
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019

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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