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Image Evaluation of Intalight Dream OCTA Scans With Optos FA & ICGA Images

Recruitingn/aAges 22 Years - anyAllIntalight, Inc
NCT07568704 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Dream OCT
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Where

1 site
Retina Consultants of Texas
Houston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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