| NCT ID | NCT07338461 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Heidelberg Engineering GmbH |
| Condition | Normal Eyes |
| Study Type | INTERVENTIONAL |
| Enrollment | 97 participants |
| Start Date | 2026-03-13 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 97 participants in total. It began in 2026-03-13 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Mariano Cozzi, MD
PRINCIPAL INVESTIGATOR
University of Milan, Department of Biomedical and Clinical Sciences, Luigi Sacco Hospital
Frequently Asked Questions
Who can join the NCT07338461 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Normal Eyes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07338461 currently recruiting?
Yes, NCT07338461 is actively recruiting participants. Contact the research team at Aike.Schweda@HeidelbergEngineering.com for enrollment information.
Where is the NCT07338461 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT07338461 clinical trial?
NCT07338461 is sponsored by Heidelberg Engineering GmbH. The principal investigator is Mariano Cozzi, MD at University of Milan, Department of Biomedical and Clinical Sciences, Luigi Sacco Hospital. The trial plans to enroll 97 participants.