Evaluation of Heidelberg Engineering SPECTRALIS With OCT Angiography Module

Evaluation of Heidelberg Engineering SPECTRALIS With OCT Angiography Module

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

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.

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