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

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ClinicalTrials.gov Identifier: NCT03530449
Recruitment Status : Terminated (Management decision; not patient safety related)
First Posted : May 21, 2018
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
Heidelberg Engineering GmbH

Study Description
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Brief Summary:
Repeatability and Reproducibility of OCTA Image Quality with the Heidelberg Engineering SPECTRALIS

Condition or disease Intervention/treatment
Retinal Vascular Normal Eyes 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
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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 : April 30, 2018
Actual Primary Completion Date : September 15, 2018
Actual Study Completion Date : September 15, 2018
Groups and Cohorts
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Group/Cohort 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 Name: OCTA

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

Device: Color Fundus Photography
Non-contact white light photography
Other Name: 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
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Primary Outcome Measures :
  1. OCTA image quality [ Time Frame: day 1 ]
    Image quality grading results of study selected images

  2. Visualization of key anatomical vascular structures on OCTA [ Time Frame: day 1 ]
    Grading of visibility of key anatomical vascular structures of study selected images


Eligibility Criteria
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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Pathology Population:

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 vascular 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.

Normal Population:

In order to be included in the Normal population, subjects will have to meet all inclusion/exclusion criteria for both eyes. Subjects with a history of ocular surgical interventions will be excluded except for those with refractive and/or cataract surgery.

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:

  • 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
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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): NCT03530449


Locations
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United States, New York
State University of New York College of Optometry (SUNY)
New York, New York, United States, 10036
Sponsors and Collaborators
Heidelberg Engineering GmbH
Investigators
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Principal Investigator: Mitchell W Dul, OD State University of New York College of Optometry
More Information
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Responsible Party: Heidelberg Engineering GmbH
ClinicalTrials.gov Identifier: NCT03530449    
Other Study ID Numbers: S-2018-1
First Posted: May 21, 2018    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