Normal Eyes, Age Related Macular Degeneration, Diabetic Retinopathy, Eyes With Retinal Diseases
Conditions
Brief 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.
Interventions
DEVICEAutofluorescence Imaging
Autofluorescence imaging with blue and green light and, multicolor imaging
DEVICEInfrared reflectance imaging
Infrared reflectance imaging, 30° Field of View
DEVICEOCT imaging
OCT Imaging Volume and Line Scans
DEVICEOCTA imaging
OCT Angiography, volume and SCOUT scan
Sponsors
Heidelberg Engineering GmbH
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cSLO Image quality grading | 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 |
| Visability of key anatomical structures | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety Monitoring | from enrollment to study completion (expected 1 year after initiation) | Observation of possible adverse events |
Countries
Italy
Contacts
Primary ContactAike T. Schweda, PhD
Backup ContactClinical Trials
Outcome results
None listed