Retinal Vascular, Normal Eyes
Conditions
Brief summary
Assessment of image quality and clinical relevance of OCT Angiography via comparison to FA/ICGA.
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.
Interventions
DEVICEOCT 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.
DEVICEColor Fundus Photography
Non-contact white light photography.
DEVICEFluorescein 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.
DEVICEIndocyaine 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.
Sponsors
Heidelberg Engineering GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OCTA image quality | day 1 | Image quality grading results of study selected images |
| Clinically relevant findings on OCTA | day 1 | Clinically relevant grading results of study selected images |
Countries
United States
Outcome results
None listed