7. The average amount of higher order aberrations present for a 7.5mm pupil was equivalent to the wave-front error produced by less than ¼ of defocus.
8.
9. Why Now? High Precision Preoperative Biometry Curvature of the Cornea (Keratometry) Axial Length / Length of the Eye (biometry) Estimate IOL Position IOL Dependent (Design, Material, etc.) Surgeon Technique Dependent (Optimization Formula) Calculate IOL Power Now More Accurate Now More Accurate Now More Accurate
10. Choosing an IOL Power Actual Study Patient: JLOS375 Preoperative Measurements IOL Power Options
12. Actual Study Patient: JLOS375 New Standard: Expanded IOL Power Increments Choosing an IOL Power
13. The Softec HD PS eliminates a MAJOR accuracy variable. Actual Study Patient: JLOS375 Physician Choice Choosing an IOL Power
14.
15.
16.
17. Standard Outcomes However current industry standards 9,10,11 for postoperative refractive error (diopters from target) are as follows: 9 Gale RP, et al. Eye . 2009; 23:149-152. 10 Zaidi FH, et al. Br J Ophthalmol. 2007; 91: 731-736. 11 Lundstr ӧ m M, Stenevi U, Thorburn W. Acta Ophthalmol Scand . 2002; 80; 248-257. 0.5 D Defocus 1.0 D Defocus 4mm pupil diameter, Aspheric IOL 4mm pupil diameter, Aspheric IOL ~50% within 0.50 D of target ~80% within 1.00 D of target
18. Cumulative Target vs. Achieved Refraction * * Clinical trial data on file at Lenstec, Inc. ~50% ~70% ~80% ~95% Percent n=305 n=306 n=295 n=291 8 Sites New Standard
19. Cumulative Target vs. Achieved Refraction * Percent * Data on file at Lenstec, Inc. 12 Month Postoperative Data; 1 Clinical Trial Site (n=10/group)
20. Cumulative Uncorrected Visual Acuity * * Data on file at Lenstec, Inc. Percent Industry Standard: 93% 20/40 or better BEST CORRECTED Driving vision 12 Month Postoperative Data; 1 Clinical Trial Site (n=10/group)
21.
22. More Precise IOL Tighter tolerances & smaller lens increments = more accurate results More accurate results -> improved postoperative visual acuity. High Precision New Standard Softec HD PS ± 1.00 D = 80% ± 0.50 D = 50% ± 0.25 D = 40% ± 0.75 D = 85% ± 1.00 D = 95% ± 0.50 D = 70% Industry Standard
23.
24.
25. MNREAD is used with normal or low vision patients to assess the reading performance/speed with different print sizes
26. 74% 99% Percent of Cases 20/20 20/25 20/32 92% 100% 20/40 37% 20/16 Percent of Cases PRINT SIZE (logMAR)
27. MNREAD Functional Vision Testing Bilateral Implantation at 1 Year Tetraflex vs. Monofocal Control Tetraflex Control Denotes statistical significance * * * * * 20/20 20/25 20/32 20/40 20/16 20/50 20/63
28. MNREAD Functional Vision Testing Bilateral Implantation Stability of Tetraflex Reading 1 Year 2 Years 6 Months 20/20 20/25 20/32 20/40 20/16 20/50 20/63
29.
30. MNREAD Functional Vision Testing Bilateral Implantation at 1 Year Tetraflex vs. crystalens Tetraflex crystalens Denotes statistical significance * * * * * 20/20 20/25 20/32 20/40 20/16 20/50 20/63
31. MNREAD Functional Vision Testing Bilateral Implantation at 1 Year Tetraflex vs. Control vs. Crystalens Tetraflex crystalens Denotes statistical significance Control * * * * * 20/20 20/25 20/32 20/40 20/16 20/50 20/63
32.
33.
34.
35.
36. Your standard IOL is likely to be the greatest source of refractive error.
Hinweis der Redaktion
Take back to slide showing difference between 0.0 D, 0.25 D and 0.50 D defocus. Clinical Trial data on 18-25D range.
All patients in 18-25 D range (PS series). All patients contralaterally implanted Tecnis in one eye & Softec in other eye. Monovision patient excluded (n=1). One patient with with Amblyopia excluded (n=1). Softec HD PS Mean = 0.18 +/- 0.11 Tecnis Mean = 0.27 +/- 0.18 Note: Small Sample Size
Note: For Softec UCVA ≠20/20 to 20/25 in 90% of cases (like target v achieved ≤0.25 D) due to pc fibrosis (4 mild cases). One patient is 20/40. He/she was 20/20 at 3-6 Month visit -> PCO.
All comparisons being made between the Tetraflex and 3-piece Collamer monofocal control IOL were tested for statistical significance using the Wilcoxon Two-sample or Mann-Whitney U-Test. The null hypothesis was that the value produced by the Tetraflex lens was either the same as or worse than (lower value) that produced by the control lens; thus 1-sided tests were used to test for the Tetraflex value being better (higher) than that of the control. MNRead functional vision testing was administered binocularly to bilaterally implanted Tetraflex and Control cases at 1 year postoperatively. Reading speed in Words per Minute in a semi-logarithmic scale is given on the Y Axis while Print size in Snellen equivalents of LogMAR values is given on the X-Axis. The graphs are similar up to a print size of 20/80 vision and then the controls begin to lose the ability to read in terms of reading speed relative to the Tetraflex IOL. The Tetraflex was statistically significantly better than the controls at print sizes of 20/63 (p=0.02), 20/50 (p=0.004), 20/40 (p=0.006), 20/32 (p<0.001), and 20/25 (p=0.001). Note that even at the 20/40 print size which is smaller than classified advertising text or telephone directory print, the reading speed with the Tetraflex IOL averages about 49 words per minute compared to only 23 words per minute for the control IOL. No patient in the control group could read the 20/25 line so the reading speed is zero after 20/32.
This graph compares the currently available 6 month, 1 year, and 2 year Tetraflex MNREAD data demonstrating no significant loss of reading ability between 6 months and 2 years postoperatively.
Tetraflex cases were enrolled as part of the U.S. FDA clinical trial. A consecutive series of Crystalens cases that returned to the practices collecting MNRead data from our clinical trial who were between 1 to 1.5 years postoperatively were also enrolled. As can be seen above, the Crystalens and Tetraflex cases were of similar age, similar follow-up and had similar visual potential (greater than 20/20 on average). All Crystalens cases were model 5.0.
All comparisons being made between the Tetraflex and Crystalens were tested for statistical significance using the Wilcoxon Mann-Whitney U-Test. The null hypothesis was that the value produced by the Tetraflex lens was the same as that produced by the Crystalens; thus 2-sided tests were used to test for the Tetraflex value compared to that of the Crystalens. MNRead functional vision testing was administered binocularly to bilaterally implanted Tetraflex and Crystalens cases at an average of 13-14 months post-operatively. Reading speed in Words per Minute in a semi-logarithmic scale is given on the Y Axis while Print size in Snellen equivalents of LogMAR values is given on the X-Axis. The graphs are similar from larger print sizes down to a print size of 20/63 vision and then the Crystalens patients begin to lose the ability to read in terms of reading speed relative to the Tetraflex patients. The Tetraflex was statistically significantly better than the Crystalens at print sizes of 20/63 (p=0.004), 20/50 (p=0.002), 20/40 (p=0.001), 20/32 (p=0.003) and 20/25 (p=0.001). Note that even at the 20/40 print size which is smaller than classified advertising text or telephone directory print, the reading speed with the Tetraflex IOL averages about 52 words per minute compared to only 25 words per minute for the Crystalens IOL. While one usually thinks of good reading vision as the ability to read 20/20 or 20/25 print sizes, it has recently been pointed out that commonly read print objects such as telephone directory, stock quotations, or newspaper print are all larger than 20/40 print. 1 Richter-Mueksch, et al. have suggested that reading the 20/50 line would be a good criterion for reasonable reading performance. 2 Sanders D, Sanders M. Near Visual Acuity for Everyday Activities with Accommodative and Monofocal Intraocular Lenses. J Refract Surg 2007;23:747-51. Richter-Mueksch S, Weghaupt H, Skorpik C, Velikay-Parel, Radner W. Reading performance with a refractive multifocal and a diffractive bifocal intraocular lens. J Cataract Refract Surg 2002,28:1957-63.
![[object Object],[object Object],[object Object],[object Object],[object Object]](data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7)