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High Resolution Imaging OCT Study

NCT07338461 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2026-01-15

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Heidelberg Engineering GmbH

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-12
Primary Completion
2026-11-30
Completion
2027-02-28

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07338461 on ClinicalTrials.gov