High Resolution Imaging OCT Study
High Resolution Imaging OCT Pilot Study
1 other identifier
interventional
97
1 country
1
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 25, 2025
CompletedStudy Start
First participant enrolled
January 12, 2026
CompletedFirst Posted
Study publicly available on registry
January 13, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 28, 2027
January 15, 2026
November 1, 2025
11 months
November 25, 2025
January 13, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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: 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
6 months after image acquisition
Secondary Outcomes (1)
Safety Monitoring
from enrollment to study completion (expected 1 year after initiation)
Study Arms (3)
Investigational device R1
EXPERIMENTALImaging with the investigational device R1
HighRes OCT
EXPERIMENTALImaging with the investigational device HighRes OCT
SPECTRALIS
OTHERImaging with the approved device SPECTRALIS
Interventions
Autofluorescence imaging with blue and green light and, multicolor imaging
OCT Angiography, volume and SCOUT scan
Infrared reflectance imaging, 30° Field of View
Eligibility Criteria
You may qualify if:
- All Able and willing to undergo the test procedures, give consent, and to follow instructions.
- 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
You may not qualify if:
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Biomedical and Clinical Sciences, Luigi Sacco Hospital, University of Milan
Milan, 20157, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mariano Cozzi, MD
University of Milan, Department of Biomedical and Clinical Sciences, Luigi Sacco Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2025
First Posted
January 13, 2026
Study Start
January 12, 2026
Primary Completion (Estimated)
November 30, 2026
Study Completion (Estimated)
February 28, 2027
Last Updated
January 15, 2026
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share