Evaluation of the Repeatability and Reproducibility of OCTA Image Quality With the Heidelberg Engineering SPECTRALIS With OCT Angiography Module
NCT ID: NCT03530449
Last Updated: 2019-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
39 participants
OBSERVATIONAL
2018-04-30
2018-09-15
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Subjects with Normal Eyes
Color Fundus Photography, Optical Coherence Tomography, and OCT Angiography scans as per protocol in subjects without ophthalmic pathology
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.
Color Fundus Photography
Non-contact white light photography
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.
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
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.
Color Fundus Photography
Non-contact white light photography
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.
Interventions
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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.
Color Fundus Photography
Non-contact white light photography
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
22 Years
ALL
Yes
Sponsors
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Heidelberg Engineering GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Mitchell W Dul, OD
Role: PRINCIPAL_INVESTIGATOR
State University of New York College of Optometry
Locations
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State University of New York College of Optometry (SUNY)
New York, New York, United States
Countries
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Other Identifiers
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S-2018-1
Identifier Type: -
Identifier Source: org_study_id