High Resolution Imaging OCT Study
Trial statusNot yet recruiting
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
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
Treatments tested in this trial
- Autofluorescence Imaging
- Infrared reflectance imaging
- OCT imaging
- OCTA imaging
Treatment groups
97 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov