Dream OCT: This study employs the Dream OCT to image the eyes of patients with retina pathology
Study summary
The goal of this study is to evaluate the image quality and clinical utility of the OCTA images from the VG200D OCT device (investigational device) compared against the FA and ICGA images from the UWF Optos California (CA) device. Image assessment will be conducted by three expert image graders and involve the assessment of the images based on both image quality and clinical utility. Evidence for substantial equivalence will be obtained through establishing similar image evaluation results across the devices based on image quality and clinical utility.
Eligibility
Sex
ALL
Min age
22 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Subjects 22 years of age or older on the date of informed consent
* Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
* BCVA 20/400 or better in the study eye
* Diagnosis of retinal associated pathology by investigator with the need to have an FA and/or ICGA performed in at least one eye
Exclusion Criteria:
* Subjects unable to tolerate ophthalmic imaging
* Subjects not able to obtain acceptable OCT images due to ocular media opacity or other reasons
* Subject has a condition or is in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
Primary outcome measure(s)
Image assessment of retinal images — All images and clinical study data will be collected in one clinical visit, which typically should take approximately 1 hour. The outcome measure is the image grading of retinal images including OCTA and FA and or ICGA images as graded by experts
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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