RECRUITING Not applicable ClinicalTrials.gov

High Resolution Imaging OCT Study

Sponsor: Heidelberg Engineering GmbH • ClinicalTrials.gov ID: NCT07338461

Registry updated: 2026-08-26

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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. Participants will be imaged with different imaging modalities and scan protocols on all study devices.

Interventions

Autofluorescence Imaging (Device)
Autofluorescence imaging with blue and green light and, multicolor imaging
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

Eligibility criteria

Inclusion Criteria: * 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 Criteria: * 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.

Conditions

Normal Eyes Age Related Macular Degeneration Diabetic Retinopathy Eyes With Retinal Diseases

Locations

Department of Biomedical and Clinical Sciences, Luigi Sacco Hospital, University of Milan — Milan, Italy

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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