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AcrySof ® ReSTOR ® Aspheric IOL
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Aspheric IOL AcrySof ® ReSTOR ® 2 AcrySof ® ReSTOR ® Aspheric IOL SN6AD3 Add Power: +4 D Spectacle Plane: 3.2 D Range: +10 D to +34 D A-Constant: 118.9 SN6AD1 Add Power: +3 D Spectacle Plane: 2.4 D Range: +10 D to +34 D A-Constant: 118.9
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Aspheric IOL AcrySof ® ReSTOR ® 3 Aspheric (SN6AD3) vs. Spheric (SN60D3) Introduction of SN6AD1 True performance at near, intermediate and distance Comparison between SN6AD1 and SN6AD3 High resolution image quality Minimal visual disturbances Discussion Topics
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Aspheric IOL AcrySof ® ReSTOR ® 4 Anatomy of the Apodized Diffractive Technology Central 3.6 mm apodized diffractive structure Step heights decrease peripherally from 1.3 – 0.2 microns A +4 D at lens plane equaling +3.2 at spectacle plane Outer refractive zone Anterior aspheric optic
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Aspheric IOL AcrySof ® ReSTOR ® 5 Anatomy of the Apodized Diffractive Technology 13.0 mm Anterior Apodized Diffractive Optic 6.0 mm Symmetric Biconvex Anterior Aspheric Optic
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Aspheric IOL AcrySof ® ReSTOR ® 6 Gradual reduction or blending of the diffractive step heights. Optimally manages light energy delivered to the retina as it distributes the appropriate amount of light to near and distant focal points, regardless of the lighting situation. Designed to improve image quality while minimizing visual disturbances. Apodization 1.3 micron step
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Aspheric IOL AcrySof ® ReSTOR ® 7 Technology of the AcrySof ® ReSTOR ® IOL in “Human” Terms Thickness of a Human Hair = 60 microns Thickness of a Red Blood Cell = 7 microns Step Height at periphery of the diffractive portion of the AcrySof ® ReSTOR ® Aspheric IOL = 0.2 microns
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Aspheric IOL AcrySof ® ReSTOR ® 8 Design considerations for the AcrySof ® ReSTOR ® Aspheric IOL: –Induce negative Spherical Aberrations with the lens to compensate for positive corneal Spherical Aberrations Design Objective
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Aspheric IOL AcrySof ® ReSTOR ® 9 Spherical aberration occurs when light rays are over-refracted at the periphery of a lens system, resulting in a region of defocused light which can decrease image quality. The Problem – Spherical Optics Spherical Aberration Marginal Rays Paraxial Rays Light Rays Spherical IOL * Smith, G., Atchinson D.A., (1997) The Eye and Visual Optical Instruments. Cambridge University Press, Cambridge, United Kingdom, pp. 667.
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Aspheric IOL AcrySof ® ReSTOR ® 10 Aspheric Surface Aspheric optics align the light rays to compensate for positive corneal spherical aberration, resulting in enhanced image quality. The Solution – Aspheric Optics * Smith, G., Atchinson D.A., (1997) The Eye and Visual Optical Instruments. Cambridge University Press, Cambridge, United Kingdom, pp. 667. Light Rays Aspheric IOL
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AcrySof ® ReSTOR ® 11 AcrySof ® ReSTOR ® Aspheric IOL (SN6AD3) Specifications 13.0 mm 6.0 mm OPTICS MultifocalApodized Diffractive Optic Compensation for Positive Corneal Spherical Aberration Aspheric Optic Optic TypeProprietary Symmetric Biconvex Optic Diameter6.0 mm Overall Length 13.0 mm MATERIAL Optic/Haptic MaterialAcrySof ® Hydrophobic Acrylic Light FiltrationUV and High-Energy Blue DESIGN IOL DesignSingle-Piece Haptic Design STABLEFORCE ® Modified-L SPECIFICATIONS Diopter Range+10 D – +30 D in 0.5 D increments +31 D – +34 D in 1.0 D increments
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Introducing AcrySof ® ReSTOR ® Aspheric IOL +3 D
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Aspheric IOL AcrySof ® ReSTOR ® 13 Offer an additional choice of add power Maintain existing optical design characteristics and manufacturing processes Without affecting visual disturbances or image contrast Lens Objectives
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Aspheric IOL AcrySof ® ReSTOR ® 14 Utilizes existing ReSTOR ® Aspheric +4 D platform with identical asphericity, energy distribution profile, and shape factor Modified add power from +4 D to +3 D –9 diffractive rings vs. 12 diffractive rings –Slightly wider ring spacing to modify the add power SN6AD1 Design Characteristics
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Aspheric IOL AcrySof ® ReSTOR ® 15 Both +4 D and +3 D have 3.6 mm Apodized Diffractive region +4 D central zone diameter = 0.742 mm +3 D central zone diameter = 0.856 mm Physical Comparison +4 D, 12 zones +3 D, 9 zones
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Aspheric IOL AcrySof ® ReSTOR ® 16 Diffractive step height profile and energy distribution are identical for +4 D and +3 D ReSTOR ® Aspheric IOLs Physical Comparison ReSTOR ® Energy Balance 4.0 D add vs. 3.0 D add ReSTOR ® Aspheric +3 D Distance ReSTOR ® +4 D Add Distance ReSTOR ® Aspheric +4 D Near ReSTOR ® Aspheric +3 D Near Data on File. Alcon, Inc.
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Aspheric IOL AcrySof ® ReSTOR ® 17 Study Objective To confirm that the increase in the distance of near vision for the ReSTOR ® Aspheric +3 D IOL does not negatively impact: visual acuity at near, distance, or intermediate contrast sensitivity halo visual disturbance scores as compared to the ReSTOR ® Aspheric +4 D IOL
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Aspheric IOL AcrySof ® ReSTOR ® 18 Study Design Prospective Randomized Subject masked 6 month duration with FDA submission at 3 months 300 subjects bilaterally implanted with either –AcrySof ® ReSTOR ® Aspheric +3 D IOL Model SN6AD1 –AcrySof ® ReSTOR ® Aspheric +4 D IOL Model SN6AD3 Approximately 20 subjects at each site
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True VA Performance Near Intermediate Distance
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Aspheric IOL AcrySof ® ReSTOR ® 20 Mean Distance VA 20/20 20/25 Both VAs are less than one letter different 20/32 20/40 Data on File. Alcon, Inc.
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Aspheric IOL AcrySof ® ReSTOR ® 21 Mean Near VA at Best Distance 20/20 20/25 Both VAs are less than two letters different and both 20/25 20/32 20/40 Data on File. Alcon, Inc.
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Aspheric IOL AcrySof ® ReSTOR ® 22 Mean Distance of Best Near VA ReSTOR ® Aspheric +3 D has approximately 6.5 cm (2.6 in) increase in distance compared to ReSTOR ® Aspheric +4 D Data on File. Alcon, Inc. Distance in cm
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Aspheric IOL AcrySof ® ReSTOR ® 23 Mean Uncorrected Intermediate VA Data on File. Alcon, Inc. 20/20 20/25 20/32 20/40 VAs are approximately 1-1.5 line(s) better for ReSTOR ® Aspheric +3 D
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Aspheric IOL AcrySof ® ReSTOR ® 24 Data on File. Alcon, Inc. 20/20 20/25 20/32 20/40 Mean Distance Corrected Intermediate VA VAs are approximately 1.5 lines better for ReSTOR ® Aspheric +3 D
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Aspheric IOL AcrySof ® ReSTOR ® 25 Data on File. Alcon, Inc. Combined VA’s: Distance, Intermediate, Near
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Aspheric IOL AcrySof ® ReSTOR ® 26 Data on File. Alcon, Inc. Bilateral Defocus Curve logMAR Refraction (D) 20/20 20/40
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Aspheric IOL AcrySof ® ReSTOR ® 27 Clinical Defocus Curve
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Aspheric IOL AcrySof ® ReSTOR ® 28 Data on File. Alcon, Inc. Distance Contrast Sensitivity Mean Photopic without Glare
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Aspheric IOL AcrySof ® ReSTOR ® 29 Data on File. Alcon, Inc. Distance Contrast Sensitivity Mean Photopic with Glare
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Aspheric IOL AcrySof ® ReSTOR ® 30 Data on File. Alcon, Inc. Distance Contrast Sensitivity Mean Mesopic without Glare
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Aspheric IOL AcrySof ® ReSTOR ® 31 Data on File. Alcon, Inc. Distance Contrast Sensitivity Mean Mesopic with Glare
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Aspheric IOL AcrySof ® ReSTOR ® 32 Data on File. Alcon, Inc. *Trademarks are property of their respective owners. Distance Image Quality in Mesopic Conditions MTF measured with model eye at 100 lp/mm. All IOL powers range from 20.0D to 22.0D
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Minimal Visual Disturbances
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Aspheric IOL AcrySof ® ReSTOR ® 34 Data on File. Alcon, Inc. Mean Visual Disturbances Mild ModerateSevereNone
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Aspheric IOL AcrySof ® ReSTOR ® 35 Mean Visual Disturbances ACRI.LISA*REZOOM*TECNIS* ReSTOR® Aspheric +4 D ReSTOR® Aspheric +3 D *Trademarks are property of their respective owners. Images provided by Jim Schwiegerling at the University of Arizona
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Aspheric IOL AcrySof ® ReSTOR ® 36 Data on File. Alcon, Inc. Frequency of Spectacle Wear (Distance Vision) How often do you wear glasses?
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Aspheric IOL AcrySof ® ReSTOR ® 37 Data on File. Alcon, Inc. Frequency of Spectacle Wear (Overall) How often do you wear glasses?
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Aspheric IOL AcrySof ® ReSTOR ® 38 Data on File. Alcon, Inc. 96% of ReSTOR +3 Patients Would Have the Same Implant Again Would you have the same implant again? Percent of Subjects
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Aspheric IOL AcrySof ® ReSTOR ® 39 True performance at near, intermediate, and distance ReSTOR ® Aspheric +3 D IOL provides a range of near vision –Best distance approximately 7cm out for ReSTOR ® Aspheric +3 D IOL 1 – 1.5 line(s) improvement in intermediate VA Aspheric optic provides improved image quality No significant differences in visual disturbances High rate of patient satisfaction and spectacle independence AcrySof ® ReSTOR ® Aspheric IOL Conclusions
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