Department of Biomedical and Clinical Sciences, Luigi Sacco Hospital, University of Milan
Milan, 20157, Italy
NCT Number: NCT07338461
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Milan, 20157, Italy
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Signed informed consent Age ≥ 18 years
Exclusion criteria
Autofluorescence imaging with blue and green light and, multicolor imaging
Infrared reflectance imaging, 30° Field of View
OCT Imaging Volume and Line Scans
OCT Angiography, volume and SCOUT scan
Time frame: 6 months after image acquisition
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
Visibility of
OCT image:
OCTA image:
Time frame: from enrollment to study completion (expected 1 year after initiation)
Observation of possible adverse events
Contact information is provided by the study sponsor or research team.
Aike T. Schweda, PhD
CONTACT
Clinical Trials
CONTACT
Heidelberg Engineering GmbH
Industry
High Resolution Imaging OCT Pilot Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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