NCT07338461Recruiting
High Resolution Imaging OCT Study
High Resolution Imaging OCT Pilot Study
Source: ClinicalTrials.gov · Last updated 26 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 97 (estimated)
- First submitted
- 25 Nov 2025
- Start date
- 13 Mar 2026
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- Heidelberg Engineering GmbH
- Diseases
- Macular degeneration, Diabetic eye disease
- NCT number
- NCT07338461
What you commit to
- Study type: Interventional
- Planned participants: 97
- From 13 Mar 2026 to the primary completion date, 30 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of photosensitive epilepsy
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Biomedical and Clinical Sciences, Luigi Sacco Hospital, University of Milan Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.