The goal of this pilot study is to compare image quality between the investigational devices (R1 and HighRes OCT) and the SPECTRALIS (cleared) in adult participants with normal and/or pathology eyes. Participants will be imaged with different imaging modalities and scan protocols on all study devices.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
97
Autofluorescence imaging with blue and green light and, multicolor imaging
Infrared reflectance imaging, 30° Field of View
OCT Imaging Volume and Line Scans
Department of Biomedical and Clinical Sciences, Luigi Sacco Hospital, University of Milan
Milan, Italy
cSLO Image quality grading
Good: Good focus, even illumination, optimal exposure Average: The image is of sub-optimal quality, where there are issues with focus, illumination, or exposure, but the image still allows assessment of clinically relevant content Poor: Clinically relevant features are not visible, images are not clinically useful
Time frame: 6 months after image acquisition
Visability of key anatomical structures
Visibility of OCT image: 1. Difference in reflectivity between the outer retino-choroidal complex and vitreous 2. The vitreo-retinal interface 3. Difference in reflectivity between retinal nerve fiber layer and vitreous 4. Difference in reflectivity between plexiform layer and vitreous 5. Multiple layers within the outer retino-choroidal complex 6. The ganglion cell layer 7. Difference in reflectivity between outer nuclear layer and vitreous 8. External limiting membrane 9. Choroidal/scleral interface OCTA image: 1. Foveal avascular zone 2. Large vessels: 1st order vasculature, if applicable 3. Medium vessels: 2nd and 3rd order vasculature 4. Small vessels: between 3rd order vasculature and end capillaries 5. End capillaries
Time frame: 6 months after image acquisition
Safety Monitoring
Observation of possible adverse events
Time frame: from enrollment to study completion (expected 1 year after initiation)
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OCT Angiography, volume and SCOUT scan