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First received: September 12, 2023

Clinical Trial: Comparative Study of the Tomey OA-2000, Tomey CASIA2, and the LenStar LS900

Study Status: Completed

Recruit Status: RECRUITING

Condition: Cataract

Study Type: OBSERVATIONAL


Official Title: Comparative Study of the Tomey OA-2000, Tomey CASIA2, and the LenStar LS900

Brief Summary: This is a prospective comparative study that will be conducted at one clinical site in the United States, in which subjects who sign an informed consent form and fulfil all inclusion and exclusion criteria, will have OCT scans obtained using the test and the predicate devices.There will be two main types of analyses performed as part of this study, including 1) a precision analysis, and 2) an agreement analysis.The precision analyses will be conducted utilizing all complete complements of acceptable scans from the…

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