High Resolution Imaging OCT Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Autofluorescence Imaging, Infrared reflectance imaging, OCT imaging, OCTA imaging.
- Who it may be relevant to
- Registry conditions: Normal Eyes, Age Related Macular Degeneration, Diabetic Retinopathy, Eyes With Retinal Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
High Resolution Imaging OCT Pilot Study
Overview
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
- Device Autofluorescence Imaging
Autofluorescence imaging with blue and green light and, multicolor imaging - Device Infrared reflectance imaging
Infrared reflectance imaging, 30° Field of View - Device OCT imaging
OCT Imaging Volume and Line Scans - Device OCTA imaging
OCT Angiography, volume and SCOUT scan
Primary outcome measures
- cSLO Image quality grading [Time frame: 6 months after image acquisition]
- Visability of key anatomical structures [Time frame: 6 months after image acquisition]
Secondary outcome measures (1)
- Safety Monitoring [Time frame: from enrollment to study completion (expected 1 year after initiation)]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Other
Study locations
Italy · 1 center
- Department of Biomedical and Clinical Sciences, Luigi Sacco Hospital, University of Milan — Milan
Identifiers
NCT: NCT07338461 · R-2025-1