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Keep this study
Lead
Heidelberg Engineering GmbH
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.
Age
22–any
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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.
You may not be if
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
Clareo Health | Evaluation of Heidelberg Engineering SPECTRALIS With OCT Angiography Module
