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NCT Number: NCT07338461

High Resolution Imaging OCT Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Milan, 20157, Italy

Location contact

Mariano Cozzi, MD

CONTACT

[email protected]

+39 0239042666

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. cSLO Image quality grading

    Time frame: 6 months after image acquisition

    Good: Good focus, even illumination, optimal exposure Average: The image is of sub-optimal quality, where there are issues with focus, illumination, or exposure, but the image still allows assessment of clinically relevant content Poor: Clinically relevant features are not visible, images are not clinically useful

  2. Visability of key anatomical structures

    Time frame: 6 months after image acquisition

    Visibility of

    OCT image:

    • Difference in reflectivity between the outer retino-choroidal complex and vitreous
    • The vitreo-retinal interface
    • Difference in reflectivity between retinal nerve fiber layer and vitreous
    • Difference in reflectivity between plexiform layer and vitreous
    • Multiple layers within the outer retino-choroidal complex
    • The ganglion cell layer
    • Difference in reflectivity between outer nuclear layer and vitreous
    • External limiting membrane
    • Choroidal/scleral interface

    OCTA image:

    • Foveal avascular zone
    • Large vessels: 1st order vasculature, if applicable
    • Medium vessels: 2nd and 3rd order vasculature
    • Small vessels: between 3rd order vasculature and end capillaries
    • End capillaries

Secondary outcomes

  1. Safety Monitoring

    Time frame: from enrollment to study completion (expected 1 year after initiation)

    Observation of possible adverse events

Study contacts

Contact information is provided by the study sponsor or research team.

Aike T. Schweda, PhD

CONTACT

[email protected]

+49 62216463387

Clinical Trials

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Heidelberg Engineering GmbH

Industry

Registry information

Official study title

High Resolution Imaging OCT Pilot Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jan 13, 2026
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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