Evaluation of Heidelberg Engineering SPECTRALIS With OCT Angiography Module

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.

• OCT Angiography (Device), also known as OCTA: 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 (Device), also known as CFP: Non-contact white light photography.
• Fluorescein Angiography (Device), also known as FA: 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.
• Indocyaine Green Angiography (Device), also known as ICGA: 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.

Primary outcomes

• 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

Sex: All, ages: 22 Years to any, accepts healthy volunteers

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

• David Brown, MD, Principal investigator, Retina Consultants Houston