Comparing eye scan image quality in healthy eyes and eyes with retinal disease
Compares eye scan images from new devices with an existing scanner in adults.
Plain-language title generated from the registry record
Registry title: High Resolution Imaging OCT Study
Key facts
- Where
- Milan, ItalySee the site
Where in Italy
- Department of Biomedical and Clinical Sciences, Luigi Sacco Hospital, University of MilanMilan, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Heidelberg Engineering GmbH
- Trial code
- NCT07338461
- Record updated
- 26 August 2026
- Original description
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.Read full original descriptionShow less
High Resolution Imaging OCT Pilot Study
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.
Inclusion: 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.
Exclusion: History of photosensitive epilepsy; 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; 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.