High Resolution Imaging OCT Study

January 13, 2026 updated by: Heidelberg Engineering GmbH

High Resolution Imaging OCT Pilot 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

97

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Milan, Italy, 20157
        • Department of Biomedical and Clinical Sciences, Luigi Sacco Hospital, University of Milan
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HighRes OCT
Imaging with the investigational device HighRes OCT
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
Other: SPECTRALIS
Imaging with the approved device SPECTRALIS
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
Experimental: Investigational device R1
Imaging with the investigational device R1
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months after image acquisition
Visability of key anatomical structures
Time Frame: 6 months after image acquisition

Visibility of

OCT image:

  1. Difference in reflectivity between the outer retino-choroidal complex and vitreous
  2. The vitreo-retinal interface
  3. Difference in reflectivity between retinal nerve fiber layer and vitreous
  4. Difference in reflectivity between plexiform layer and vitreous
  5. Multiple layers within the outer retino-choroidal complex
  6. The ganglion cell layer
  7. Difference in reflectivity between outer nuclear layer and vitreous
  8. External limiting membrane
  9. Choroidal/scleral interface

OCTA image:

  1. Foveal avascular zone
  2. Large vessels: 1st order vasculature, if applicable
  3. Medium vessels: 2nd and 3rd order vasculature
  4. Small vessels: between 3rd order vasculature and end capillaries
  5. End capillaries
6 months after image acquisition

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety Monitoring
Time Frame: from enrollment to study completion (expected 1 year after initiation)
Observation of possible adverse events
from enrollment to study completion (expected 1 year after initiation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg Engineering GmbH

Investigators

  • Principal Investigator: Mariano Cozzi, MD, University of Milan, Department of Biomedical and Clinical Sciences, Luigi Sacco Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 12, 2026

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

February 28, 2027

Study Registration Dates

First Submitted

November 25, 2025

First Submitted That Met QC Criteria

January 5, 2026

First Posted (Estimated)

January 13, 2026

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-2025-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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