Analysis Methods Clause Samples

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. 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.)

Analysis Methods. Descriptive summaries (counts and percentages) for ocular and nonocular AEs will be presented by Medical Dictionary for Regulatory Activities Preferred Terms, for Completed and Discontinued analysis sets. A listing containing details of the AEs will also be provided. Each biomicroscopy parameter will be tabulated by its grade, on Completed and Discontinued analysis sets. Frequency for each device deficiency category will be presented and a supporting listing will be provided.

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. A mixed effect repeated measures model will be fit to test these hypotheses, including terms for lens care solution, period, sequence group, and baseline CLDEQ-8 as fixed effects and subject as a random effect. Lens care difference (OFPM minus HMPS) and the corresponding one-sided 95% upper confidence limit will be provided.

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. A mixed effects repeated measures model will be utilized to test these hypotheses. The model will include terms for lens, visit (Dispense, Week 1 Follow-up, Month 1 Follow-up, and Month 3 Follow-up), and lens-by-visit interaction as fixed effects, protocol as a random effect and baseline best corrected distance VA as a covariate. Within-subject correlation due to eye will also be accounted for in the model. Lens difference ( minus Biofinity) and the corresponding two-sided 95% CI will be computed for 1-Week Follow-up. Noninferiority in CLCDA will be declared if the upper confidence limit is less 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. 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. 1. If the upper bound is less than the margin, the null hypothesis will be rejected and the TNFT00 IOL will be concluded non-inferior to the 839MP IOL for UCDVA. The two-sided 95% confidence intervals will be reported for the difference between the treatment groups at each visit. 1. If the upper bound is less than the margin, the null hypothesis will be rejected and the TNFT00 IOL will be concluded non-inferior to the 839MP IOL for UCNVA. The two-sided 95% (or 90%) confidence intervals will be reported for the difference between the treatment groups at each visit. Summaries of logMAR visual acuity will also include two-sided 90% confidence intervals. A composite visual acuity endpoint comprising binocular uncorrected visual acuity at Distance (4 m) and Near (40 cm) will be summarized as a categorical variable with the following categories: 20/20 or better (≤0.04 logMAR), 20/32 or better (≤0.14 logMAR) and 20/40 or better (≤0.24 logMAR). Defocus curves will be generated for binocular defocus data, including two-sided 90% confidence intervals, with the amount of defocus along the x-axis and logMAR VA at each defocus point along the y-axis. To examine inter-site variation in outcome, forest plots of near, intermediate and distance visual acuity will be produced by plotting the difference in means and associated standard error for each site. Contrast Sensitivity will be scored and analyzed per contrast sensitivity unit instructions. Responses to the satisfaction question will be analyzed as a categorical variable.