WHAT SETS ACTIVEFOCUS DESIGN APART? THE DIFFERENCE IS IN THE DISTANCE.

Transcription

1 WHAT SETS ACTIVEFOCUS DESIGN APART? THE DIFFERENCE IS IN THE DISTANCE.

2 UNCOMPROMISED DISTANCE The ACTIVEFOCUS optic is the only multifocal featuring a central portion 1% dedicated to distance Contrast sensitivity is comparable to a monofocal IOL 1,3 ACTIVEFOCUS Optical Design: Committed to long-range vision 1,2 Binocular Mesopic Contrast Sensitivity,3 4 6 Months Post-op ACTIVEFOCUS Optical Design: Contrast at distance,4 Step Height (mm) Step Height (mm) x x 1-3 ReSTOR +2.5 D Radius (mm) Symfony, 69.4% of light distributed to distance focal point 1 4.5% of light distributed to distance focal point 2 Central portion 1% dedicated to distance 1,2 Mean Contrast Sensitivity (Log Units) cpd (n=127/13) 3 cpd (n=129/132) 6 cpd (n=116/128) 12 cpd (n=13/117) Spatial Frequency (Cycles per Degree) ReSTOR +2.5 D IOL Monofocal IOL Standard Deviation Monofocal ReSTOR +2.5 D TECNIS Multifocal D 3 mm pupil 4.5 mm pupil Radius (mm) Scaled to mm from microns (μ) for readability. Surface profile of the TECNIS Symfony 28. D IOL was measured using Bruker Contour white light interferometer on the posterior surface and the diffraction efficiency calculated. Optical profile of the ReSTOR +2.5 D IOL, model SV25T is based on its design profile. ACTIVEFOCUS Optical Design contrast sensitivity is comparable to that of IOLs. 1,3 With glare. Descriptive statistics only. Images derived from Vega, et al. figure 2 (fn 5). Slit pattern bench test displayed in logarithmic scale of intensity for halo assessment at distance vision. Only IOLs approved in the U.S. are displayed.

3 UNRIVALED STABILITY Your outcomes are only as stable as the IOL you choose Choose the proven stability of the IOL platform Just 5 rotation of a T6 lens results in:.42 D residual astigmatism 5 Residual astigmatism can compromise visual acuity in presbyopia correction 6 In evidence from thousands of cases entered into AstigmatismFix.com, IOLs were more likely to rotate 5 post-op than Toric IOLs. 7 Toric IOLs: proven rotational stability 8 13 studies More than 9 patients < 5 mean rotation from baseline for all Toric IOLs studied 2.5X more likely to rotate than Toric % off target 5, by estimated market usage,7 n=1,953 Counterclockwise 65 % 35 % n=1,953 p<.1 Clockwise Direction of Rotation for IOLs 5 off Target 7 Astigmatismfix.com is an online calculator to help surgeons determine if a previously placed toric IOL is ideally aligned. The analysis dataset includes 5,674 entries, with each unique lens and intended orientation identified, in addition to post-operative IOL orientation 5 from intended axis. The dataset was weighted based on the estimated market usage of each lens. The full evaluation included Toric,, Trulign Toric and Staar Toric IOLs. 7 Built on the same proven platform as Toric IOLs Proven Real-World Performance Toric.75% off target 5, by estimated market usage,7 n=3,556 Toric IOLs show no bias for rotational direction, unlike IOLs.,7 If the ratio of clockwise to counterclockwise rotation differs significantly from 5:5, the IOL is likely rotating in one direction more often after implantation. Evaluated studies included misorientation data from 1 to approximately 12 months post-op. Toric IOLs that rotated 5 off target showed no bias for rotational direction (51% counterclockwise and 49% clockwise, n=3,556, p=.33).

4 UNRIVALED STABILITY Excellent capsular adhesion 9,1 Engineered for optimal refractive predictability AcrySof BioMaterial Advantage: greater fibronectin binding than TECNIS IOL material to promote excellent capsule adhesion, 9,1 with low Nd:YAG rates. 11,12 AcrySof IOL BioMechanics Advantage: exceptional axial stability 18,19 STABLEFORCE Haptics Fibronectin Adhesion Comparison,9 Conforms to the capsular bag for precise centration 18,19 ug Protein Delivers the BioMaterial and BioMechanics benefits of Toric IOLs Toric IOL Profile 15 Offset haptics may be more prone to hyperopic shift. 17 TECNIS Toric IOL Profile 16 Posterior Side 1.. n=12 n=11 n=12 n=11 AcrySof TECNIS Fibronectin adsorption p<.1 Persistent fibronectin adsorption after sodium dodecyl sulfate treatment In vitro fibronectin protein adhesion assay comparing the amount of fibronectin adsorbed to AcrySof, HOYA and TECNIS acrylic IOLs, as well as polymethacrylate IOLs. Fibronectin adsorption was quantified using the Thermo Scientific Micro BCATM Protein Assay kit. IOL Toric Refractive Index: 1.55 Excellent axial positioning and rotational stability for refractive predictability 13-15,18,19 No observed rotational bias 7 15 Refractive Index: 1.47 TECNIS Toric IOL Observed bias toward counterclockwise rotation 7 Offset haptic design may increase risk of hyperopic shift 17 16

5 Take a look at ACTIVEFOCUS Optical Design The difference is in the distance. Uncompromised distance 1,3,4 Unrivaled stability 7,8,14 1. Alcon Data on File. (April 11, 216). 2. Alcon Data on File. (Oct 17, 216). 3. ReSTOR +2.5 D IOL Directions for Use. 4. Vega F, Alba-Bueno F, Millán MS, et al. Halo and through-focus performance of four diffractive multifocal and intraocular lenses. Invest Ophthalmol Vis Sci. 215;56; Ferreira TB, Marques EF, Rodrigues A, et al. Visual and optical outcomes of a diffractive multifocal toric intraocular lens. J Cataract Refract Surg. 213; 39: Hayashi K, Manabe S, Yoshida M, Hayashi H. Effect of astigmatism on visual acuity in eyes with a diffractive multifocal intraocular lens. J Cataract Refract Surg. 21;36(8): Potvin R, et al. Toric intraocular lens orientation and residual refractive astigmatism: an analysis. Clin Ophthalmol. 216;1: Visser N, Bauer NJ, Nuijts RM. Toric intraocular lenses: historical overview, patient selection, IOL calculation, surgical techniques, clinical outcomes, and complications. J Cataract Refract Surg. 213;39(4): Ong M, Wang L, Karakelle M. Fibronectin adhesive properties of various intraocular lens materials. Alcon Laboratories, Fort Worth, TX, USA. ARVO Linnola RJ, Sund M, Ylonen R, et al. Adhesion of soluble fibronectin, laminin, collagen type IV to intraocular lens materials. J Cataract Refract Surg. 1999;25(11): Boureau C, et al. Incidence of Nd:YAG laser capsulotomies after cataract surgery: comparison of 3 square edge lenses of different composition. Can J Ophthalmol. 29;44: Apple DJ, Peng Q, Visessook N, et al. Eradication of posterior capsule opacification: documentation of a marked decrease in Nd:YAG laser posterior capsulotomy rates noted in an analysis of 5,416 pseudophakic human eyes obtained postmortem. Ophthalmology. 21;18(3): Nejima R, et al. Prospective intrapatient comparison of 6.-millimeter optic single-piece and 3-piece hydrophobic acrylic foldable intraocular lenses. Ophthalmology. 26;113(4): Wirtitsch MG, et al. Effect of haptic design on change in axial lens position after cataract surgery. J Cataract Refract Surg. 24;3(1): Toric IOL Directions for Use. 16. TECNIS Toric 1-Piece Aspheric IOL Specification Sheet. Abbott Medical Optics Eldaly MA, Mansour KA. Personal A-constant in relation to axial length with various intraocular lenses. Indian J Ophthalmol. 214;62(7): Lane SS, Ernest P, Miller KM, Hileman KS, Harris B, Waycaster CR. Comparison of clinical and patient reported outcomes with bilateral AcrySof Toric or spherical control intraocular lenses. J Refract Surg. 29;25(1): Lane SS, Burgi P, Milios GS, Orchowski MW, Vaughan M, Schwarte E. Comparison of the biomechanical behavior of foldable intraocular lenses. J Cataract Refract Surg. 24;3: ReSTOR Family of Multiflocal IOLs Important Product Information CAUTION: Federal (USA) law restricts this device to the sale by or on the order of a physician. INDICATIONS: The ReSTOR Posterior Chamber Intraocular Multifocal IOLs include ReSTOR and AcrySof ReSTOR Toric and are intended for primary implantation for the visual correction of aphakia secondary to removal of a cataractous lens in adult patients with and without presbyopia, who desire near, intermediate and distance vision with increased spectacle independence. In addition, the AcrySof IQ ReSTOR Toric IOL is intended to correct pre-existing astigmatism. The lenses are intended to be placed in the capsular bag. WARNINGS/PRECAUTIONS: Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting a lens in a patient with any of the conditions described in the Directions for Use labeling for each IOL. Physicians should target emmetropia, and ensure that IOL centration is achieved. Care should be taken to remove viscoelastic from the eye at the close of surgery. The ReSTOR Toric IOL should not be implanted if the posterior capsule is ruptured, if the zonules are damaged, or if a primary posterior capsulotomy is planned. Rotation can reduce astigmatic correction; if necessary lens repositioning should occur as early as possible prior to lens encapsulation. Some patients may experience visual disturbances and/or discomfort due to multifocality, especially under dim light conditions. A reduction in contrast sensitivity may occur in low light conditions. Visual symptoms may be significant enough that the patient will request explant of the multifocal IOL. Spectacle independence rates vary; some patients may need glasses when reading small print or looking at small objects. Posterior capsule opacification (PCO), when present, may develop earlier into clinically significant PCO with multifocal IOLs. Prior to surgery, physicians should provide prospective patients with a copy of the Patient Information Brochure available from Alcon informing them of possible risks and benefits associated with the ReSTOR IOLs. Do not resterilize; do not store over 45 C; use only sterile irrigating solutions such as BSS or BSS PLUS Sterile Intraocular Irrigating Solutions. ATTENTION: Reference the Directions for Use labeling for each IOL for a complete listing of indications, warnings and precautions. 217 Novartis 8/17 US-RES-17-E-1743b Physical Characteristics Model Model Number SV25T3 SV25T4 SV25T5 SV25T6 IOL Cylinder Power (Diopters) 1.5 D 2.25 D 3. D 3.75 D Corneal Plane 1.3 D 1.55 D 2.6 D 2.57 D Add-Power Add-Power Spectacle Plane Number of Diffractive Steps Filtration Optic Material Central Optic Zone +2.5 D +2. D 7 steps (Apodized) Ultraviolet and blue light filtering Acrylate/Methacrylate Copolymer Refractive Optic Diameter 6. Overall Length 13. mm Starting A-constant / Index of Refraction 1.55 Haptic Angulation Haptic Configuration STABLEFORCE Haptic Theoretical A-constant from product labeling (optical biometry/srk-t formula at 6m) Clinically derived from US clinical study results of 294 eyes at 14 clinical sites (optical biometry/srk-t formula at 4m)