Condition: Retina Pathology · Sponsor: Intalight, Inc
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.
This description comes directly from the study's public registry record.
Mike Sinai, PhD · 6198067636 · mike.sinai@intalight.com
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| Retina Consultants of Texas | Houston, Texas, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07568704