Evaluation of Heidelberg Engineering SPECTRALIS With OCT Angiography Module

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

Detailed Description
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The objectives of this study are: To compare the OCTA image quality between the SPECTRALIS and the predicate. To compare the agreement of clinical findings on SPECTRALIS OCTA to the predicate.

Official Title
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Evaluation of Heidelberg Engineering SPECTRALIS With OCT Angiography Module

Conditions
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Retinal Vascular, Normal Eyes

Intervention / Treatment
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* Device: OCT Angiography
* Device: Color Fundus Photography
* Device: Fluorescein Angiography
* Device: Indocyaine Green Angiography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects with Normal Eyes<br>OCT Angiography, Color Fundus Photography, and Fluorescein Angiography as per protocol in subjects without ophthalmic pathology. | Device: OCT Angiography<br>* 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.<br>* Other names: OCTA;Device: Color Fundus Photography<br>* Non-contact white light photography.<br>* Other names: CFP;Device: Fluorescein Angiography<br>* 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.<br>* Other names: FA;|
| Experimental: Subjects with Pathology<br>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<br>* 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.<br>* Other names: OCTA;Device: Color Fundus Photography<br>* Non-contact white light photography.<br>* Other names: CFP;Device: Fluorescein Angiography<br>* 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.<br>* Other names: FA;Device: Indocyaine Green Angiography<br>* 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.<br>* Other names: ICGA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OCTA image quality | Image quality grading results of study selected images | day 1 | 
| Clinically relevant findings on OCTA | Clinically relevant grading results of study selected images | day 1 |