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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational device R1 | Experimental | Imaging with the investigational device R1 |
|
| HighRes OCT | Experimental | Imaging with the investigational device HighRes OCT |
|
| SPECTRALIS | Other | Imaging with the approved device SPECTRALIS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autofluorescence Imaging | Device | Autofluorescence imaging with blue and green light and, multicolor imaging |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months after image acquisition |
| Visability of key anatomical structures | Visibility of OCT image:
OCTA image:
| 6 months after image acquisition |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Monitoring | Observation of possible adverse events | from enrollment to study completion (expected 1 year after initiation) |
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Inclusion Criteria:
Signed informed consent Age ≥ 18 years
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aike T. Schweda, PhD | Contact | +49 62216463387 | Aike.Schweda@HeidelbergEngineering.com | |
| Clinical Trials | Contact | clinical.trials@HeidelbergEngineering.com |
| Name | Affiliation | Role |
|---|---|---|
| Mariano Cozzi, MD | University of Milan, Department of Biomedical and Clinical Sciences, Luigi Sacco Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Biomedical and Clinical Sciences, Luigi Sacco Hospital, University of Milan | Milan | 20157 | Italy |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
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| ID | Term |
|---|---|
| D061848 | Optical Imaging |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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| Infrared reflectance imaging | Device | Infrared reflectance imaging, 30° Field of View |
|
| OCT imaging | Device | OCT Imaging Volume and Line Scans |
|
| OCTA imaging | Device | OCT Angiography, volume and SCOUT scan |
|
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |