Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
97 participants
INTERVENTIONAL
2026-01-12
2027-02-28
Brief Summary
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Participants will be imaged with different imaging modalities and scan protocols on all study devices.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Investigational device R1
Imaging with the investigational device R1
Autofluorescence Imaging
Autofluorescence imaging with blue and green light and, multicolor imaging
Infrared reflectance imaging
Infrared reflectance imaging, 30° Field of View
OCT imaging
OCT Imaging Volume and Line Scans
OCTA imaging
OCT Angiography, volume and SCOUT scan
HighRes OCT
Imaging with the investigational device HighRes OCT
Autofluorescence Imaging
Autofluorescence imaging with blue and green light and, multicolor imaging
Infrared reflectance imaging
Infrared reflectance imaging, 30° Field of View
OCT imaging
OCT Imaging Volume and Line Scans
OCTA imaging
OCT Angiography, volume and SCOUT scan
SPECTRALIS
Imaging with the approved device SPECTRALIS
Autofluorescence Imaging
Autofluorescence imaging with blue and green light and, multicolor imaging
Infrared reflectance imaging
Infrared reflectance imaging, 30° Field of View
OCT imaging
OCT Imaging Volume and Line Scans
OCTA imaging
OCT Angiography, volume and SCOUT scan
Interventions
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Autofluorescence Imaging
Autofluorescence imaging with blue and green light and, multicolor imaging
Infrared reflectance imaging
Infrared reflectance imaging, 30° Field of View
OCT imaging
OCT Imaging Volume and Line Scans
OCTA imaging
OCT Angiography, volume and SCOUT scan
Eligibility Criteria
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Inclusion Criteria
Signed informed consent Age ≥ 18 years
* Healthy Subjects without uncontrolled systemic conditions, as determined by the investigator Subjects without ocular disease, as determined by the investigator Corrected visual acuity ≥ 20/40 No reported history of ocular surgical intervention (except for refractive or cataract surgery)
* Age-related macular degeneration Subjects with a diagnosis of AMD as determined by the investigator, either early-intermediate, atrophic, or neovascular
* Diabetic retinopathy Subjects with a diagnosis of diabetic retinopathy as determined by the investigator
* Disease with expected altered autofluorescence pattern Subjects with a disease that can be expected to be associated with altered autofluorescence patterns as determined by the investigator
Exclusion Criteria
* Subjects with ocular media not sufficiently clear to obtain acceptable study-related imaging
* Subjects who cannot tolerate the imaging procedures
* History of photosensitive epilepsy
* Vulnerable subjects, i.e., individuals with lack of or loss of autonomy due to immaturity or through mental disability, persons in nursing homes, impoverished persons, subjects in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent.
18 Years
ALL
Yes
Sponsors
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Heidelberg Engineering GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Mariano Cozzi, MD
Role: PRINCIPAL_INVESTIGATOR
University of Milan, Department of Biomedical and Clinical Sciences, Luigi Sacco Hospital
Locations
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Department of Biomedical and Clinical Sciences, Luigi Sacco Hospital, University of Milan
Milan, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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R-2025-1
Identifier Type: -
Identifier Source: org_study_id
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