Effectiveness Analyses. This study defines one primary effectiveness endpoint The Safety Analysis Set will be used for all effectiveness analyses.
Effectiveness Analyses. This study defines 1 primary endpoint FAS as the primary analysis set.
Effectiveness Analyses. For each of the primary and supportive effectiveness endpoints, separate summary tables will be prepared, when applicable, for the Completed and the Discontinued analysis sets as follows: Completed Control (eyes/subjects) Completed Test (eyes/subjects) Discontinued Control (eyes/subjects) Discontinued Test (eyes/subjects) No inferential testing will be performed on effectiveness endpoints, and format of the reporting tables will follow FDA’s 510(k) guidance document (Clinical Appendix C, Summary of Reporting Tables) as well as the ISO guidance as specified in Section A.3 (Reporting of results) of ISO 11980:2012.
Effectiveness Analyses. For the primary , separate summary tables will be prepared, when applicable, for the Completed and the Discontinued analysis sets as follows: • Completed Control (eyes/subjects) • Completed Test (eyes/subjects) • Discontinued Control (eyes/subjects) • Discontinued Test (eyes/subjects) No inferential testing will be performed on effectiveness endpoints,
Effectiveness Analyses. The objective of this study is to evaluate safety and effectiveness of the investigational lens (TFNT20, T2 hereafter) when implanted to replace the natural lens following cataract removal.
Effectiveness Analyses. This study defines 1 primary, 1 secondary,
Effectiveness Analyses. This study defines 1 primary, 1 secondary, All effectiveness evaluations will use the F effectiveness endpoints. AS as the primary analysis set.
Effectiveness Analyses. This study defines 1 primary, All effectiveness evaluations will use the FAS as the primary analysis set. analyses of the primary will be conducted using the PP Analysis Set only if the number of subjects excluded from the PP Analysis Set exceeds 5% of the FAS. A sequential gatekeeping strategy will be used to control testing of multiple effectiveness endpoints. Therefore, the overall Type I error will be maintained at one-sided 0.05 with the following testing order:
Effectiveness Analyses. This study defines 1 primary, endpoints.
Effectiveness Analyses. This study defines 1 primary, will use the FAS as the primary analysis set. The primary effectiveness endpoint of distance VA will be tested at one-sided α = 0.05 for noninferiority
