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

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

Detailed Description
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The objectives of this study are to: Assess the repeatability and reproducibility of the SPECTRALIS with OCTA Module image quality Assess the repeatability and reproducibility of visibility of key anatomical vascular structures in the SPECTRALIS with OCTA Module

Official Title
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Evaluation of the Repeatability and Reproducibility of OCTA Image Quality With the 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: Optical Coherence Tomography


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: 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

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects with Normal Eyes<br>Color Fundus Photography, Optical Coherence Tomography, and OCT Angiography scans 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: Optical Coherence Tomography<br>* 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.<br>* Other names: OCT;|
| Subjects with Retinal Vascular Pathology<br>Color Fundus Photography, Optical Coherence Tomography, and OCT Angiography scans as per protocol in subjects with retinal vascular 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: Optical Coherence Tomography<br>* 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.<br>* Other names: OCT;|

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 | 
| Visualization of key anatomical vascular structures on OCTA | Grading of visibility of key anatomical vascular structures of study selected images | day 1 |