High Resolution Imaging OCT Study

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study compares image quality across three optical coherence tomography devices using multiple scan protocols in adults with either healthy eyes or retinal conditions such as age-related macular degeneration and diabetic retinopathy. Participants undergo autofluorescence, infrared reflectance, OCT, and OCTA imaging on all devices to directly compare performance. The study is conducted at a single center in Milan, with Heidelberg Engineering GmbH as the lead sponsor. Eligible participants include healthy adults and those with specified retinal diseases, with informed consent required and exclusion of individuals with certain ocular or systemic conditions. The trial does not have a defined treatment or efficacy endpoint beyond image quality assessment.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: Mariano Cozzi, MD — University of Milan, Department of Biomedical and Clinical Sciences, Luigi Sacco Hospital
• Study coordinator: Aike T. Schweda, PhD
• Email: Aike.Schweda@HeidelbergEngineering.com
• Phone: +49 62216463387

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.