Health TrialsbyHealthPanel

High Resolution Imaging OCT Study

ConditionsNormal EyesAge Related Macular DegenerationDiabetic RetinopathyEyes With Retinal Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHeidelberg Engineering GmbH

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

All Able and willing to undergo the test procedures, give consent, and to follow instructions.

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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

Treatment groups

97 Participants
are divided into 3 treatment groups
Group A: Investigational device R1Experimental treatment 4 interventions
Group B: HighRes OCTExperimental treatment 4 interventions
Group C: SPECTRALISOther 4 interventions

Trial outcomes

Primary outcomes

1

cSLO Image quality grading

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

Time frame
6 months after image acquisition
2

Visability of key anatomical structures

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

Time frame
6 months after image acquisition

Secondary outcomes

1

Safety Monitoring

Observation of possible adverse events

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Heidelberg Engineering GmbH

Lead sponsor

Source ClinicalTrials.gov
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