Analysis Methods. A mixed effects 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 and the corresponding one-sided 95% upper confidence limit will be computed at Day 30. 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. 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, 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 CLCDVA will be declared if the upper confidence limit is less than 0.10.
Analysis Methods. Descriptive statistics will be presented, to include frequencies and percentages in each grade
Analysis Methods. For each of the supportive effectiveness endpoints, descriptive summary statistics will be computed according to the scale of measurement.
Analysis Methods. Analysis methods for sizing shall be consistent with Section 4-8 and standard engineering practice. Imported water shall not be included in the existing runoff from the site. The applicant shall submit clearly labeled calculations including: Hydrologic parameters and source(s) of data Analysis methods used Additional assumptions made (infiltration rates may require field tests, consult Public Works before proceeding) Spreadsheet, printouts, or hand calculations Results (required volume, orifice sizes, stage discharge curve for hydrograph methods, etc.)
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. 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.
