High Resolution Imaging OCT Study

Sponsor
Heidelberg Engineering GmbH
Study ID
NCT07338461
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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

Study Details

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.

Key Dates

First listed
Jan 13, 2026
Start date
Mar 13, 2026
Status verified
Nov 2025
Primary completion
Dec 30, 2026
Completion
Mar 28, 2027

Study Design

Enrollment
97 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Investigational device R1
    Imaging with the investigational device R1
  • Experimental: HighRes OCT
    Imaging with the investigational device HighRes OCT
  • Other: SPECTRALIS
    Imaging with the approved device SPECTRALIS

Primary Outcome Measure

cSLO Image quality grading [ Time Frame: 6 months after image acquisition ]

Central Contacts

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