Evaluation of Heidelberg Engineering SPECTRALIS With OCT Angiography Module

Launched by HEIDELBERG ENGINEERING GMBH · Sep 11, 2017

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• 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