Analysis Methods. A mixed effect repeated measures model will be utilized to test these hypotheses. The model will include terms for lens, visit, lens by visit interaction, period, and sequence. Within- subject correlation due to eye and the crossover design will also be accounted for in the model. Lens difference (PRECISION1 minus Clariti 1-Day) and the corresponding one-sided 95% upper confidence limit will be computed. Noninferiority in distance VA will be declared if upper confidence limit is less than 0.05.
Analysis Methods. A binary variable will be defined for each subject to indicate whether the CLCDVA at Week 1 Follow-up is no worse than 20/20 in both OD and OS, and the corresponding proportion will be computed for each lens using the number of subjects as the denominator From the two-sided 95% CI on the lens difference ( minus Biofinity), noninferiority in proportion of subjects achieving 20/20 or better in CLCDVA in both eyes will be declared if the lower confidence limit is greater than -0.10.
Analysis Methods. For each of the supportive effectiveness endpoints, descriptive summary statistics will be computed according to the scale of measurement.
Analysis Methods. The methods for determining the thresholds and screening criteria will influence the analysis methodology. We expect that data from the SANDAG Regional Travel Demand model will be used to determine thresholds and develop screening maps. Therefore, data/methodology using the SANDAG model will also need to be used to perform analysis. Consultant will recommend a procedure for performing the analysis and will identify the types/sizes of projects that can use the data from the SANDAG model and perform a manual calculation to determine the project VMT (using the appropriate metric) vs. when the project applicant would need to actually perform a model run. In addition, the input gathered for mitigation options will be used to identify a recommended procedure for evaluating mitigation measures (for example how to calculate TDM measure effectiveness and the reduction in VMT). There are several tools/resources for performing the analysis, each with advantages, drawbacks, and limitations. The analysis methodology recommendations will consider: • Accuracy and defensibility (including apples-apples consistency, as mandated in the OPR Technical Advisory) • Industry use/acceptance • Ability for independent verification by City • User considerations (such as accessibility, ease of use, cost, ease of interpretation, etc.) Deliverables: Consultant suggests combining the technical information from Tasks B.4, B.5, and B.6 into one Technical Memorandum because the topics overlap and greatly influence one another. The deliverable for Task
Analysis Methods. Buyer shall use approved NGFA analysis methods and comply with the sampling procedures per the applicable Trade Rules.
Analysis Methods. The primary hypothesis will be tested by generating a two-sided 90% confidence interval using repeated measures analysis of variance at a type I error rate of 5%, 1-sided. Tests at each visit will be reported with Visit 4A (120-180 days) prospectively identified as the primary time point of interest. The upper bound of the two-sided 90% confidence interval will be compared to the margin, 0.1. If the upper bound is less than the margin, the null hypothesis will be rejected and the TFNT00 IOL will be concluded non-inferior to the 839MP IOL for UCIVA. The two sided 90% confidence intervals will be reported for the difference between the treatment groups at each visit.
Analysis Methods. For the superiority hypothesis tests, treatment group comparison for UCIVA will be made and the first secondary objective will be demonstrated if p<0.025 from a repeated measures analysis of variance at a Type I error rate of 2.5%. Tests at each visit will be reported with Visit 4A (120-180 days) prospectively identified as the primary time point of interest. The two-sided 95% confidence intervals will be reported for the difference between treatment groups at each visit. For the fourth and fifth secondary objectives, superiority will be demonstrated if p<0.05 (or p<0.025, depending on the gatekeeping) for UCNVA and UCDVA at Visit 4A (120-180 days), respectively.
Analysis Methods. All eligible eyes will be used for the analysis. For unilaterally implanted subjects, only the eligible eye, for bilaterally implanted subjects, both eyes will be used for the analysis. The superiority of T2 to T0 regarding refractive cylinder is to be demonstrated when there is a statistically significant difference between the outcome in this study and the historical threshold of 29.2%.
Analysis Methods. For continuous variables, descriptive statistics (mean, standard deviation, N, median, min and max) will be provided for actual value and change from baseline at each visit. For categorical variables, N and percent will be provided for each category at each visit. Any additional p-values from t-statistics or chi-square type statistics will be provided accordingly only for descriptive purpose.
Analysis Methods. Descriptive statistics will be presented, to include frequencies and percentages in each grade
