Medicontur IOLs: Materials & Design Main Characteristics

Transcription

1 Medicontur IOLs: Materials & Design Main Characteristics

2 BALANCED TECHNOLOGY FOR OPTIMAL IOLs OPTICAL PERFORMANCE LONG TERM MATERIAL PERFORMANCE Material REFRACTIVE STABILITY TECHNOLOGY LOW PCO RATE STABILITY IN THE EYE Design Optic Page 2 March 2017 Medicontur Vision of Expertise

3 MEDICONTUR IOL PORTFOLIO Hydrophilic IOLs (25% and 26% water content, clear & yellow) Hydrophobic IOLs (clear & yellow) Advanced monofocal IOLs (aspheric neutral approach) Premium Toric Premium Multifocal Premium Multifocal-Toric SML & Add-On IOLs Advanced monofocal aspheric IOLs Proprietary SEMTE material with the highest ABBE number (58); Tg (4 C) On the market since 2009 Page 3 March 2017 Medicontur Vision of Expertise

4 OPTIMAL IOL BALANCED TECHNOLOGY MATERIAL REFRACTIVE INDEX (RI) CHROMATIC ABERRATION (ABBE NUMBER) BLUE-LIGHT & UV FILTERs GLASS TRANSITION TEMPERATURE (Tg) GLISTENING DESIGN SHARP EDGE (SE) HAPTIC/OPTIC DIAMETER / CHARACTERISTICs OPTIC ABERRATIONs (SPHERICAL, COMA ) COD PRECISION Page 4 March 2017 Medicontur Vision of Expertise

5 OPTIMAL IOL BALANCED TECHNOLOGY Material Design Optic Page 5 March 2017 Medicontur Vision of Expertise

6 Material HYDROPHILIC Page 6 March 2017 Medicontur Vision of Expertise

7 HYDROPHILIC BENZ 25 (USA) There are many hydrophilic IOL materials on the market DIFFERENT MATERIALs Medicontur uses BENZ 25, USA (as well as Zeiss, Physiol.) IMPORTANT! Distillation of monomers before polymerisation Disadvantage: 10% of material loss BUT DIFFERENT TECHNOLOGIEs & DIFFERENT QUALITY Advantage: clean, safe material; less prone to opacification and calcification inside a lens other companies e.g. Contamac produce without distillation process Page 7 March 2017 Medicontur Vision of Expertise

8 HYDROPHILIC BENZ 25 Mixing hydrophilic and hydrophobic monomers 25% water content after combination of the two monomers, to form a highly biocompatible polymer Medicontur foldable raw material : a combination of two monomers HEMA, highly hydrophilic monomer Pure HEMA = 38% water content BIOCOMPATIBILITY EOEMA, hydrophobic monomer Approximately 2% water content ELASTIC PROPERTIES SOFTNESS EOEMA 36% HEMA 64% Page 8 March 2017 Medicontur Vision of Expertise

9 MEDICONTUR HYDROPHILIC BENZ 25 Anti-PCO behaviour A long chain acts as a ʺmolecular eyelashʺ to prevent cell adhesion and protein deposit Our raw material : low adhesion for a low PCO rate Apart from design, polimer chain length has a proven effect against cell adhesion : Hydrogel MMA 26% Page 9 March 2017 Medicontur Vision of Expertise

10 NATURAL YELLOW FILTER for FILTERING AS MUCH AS NECESSARY for PRESERVING AS MUCH AS POSSIBLE Medicontur natural yellow filter protects the macula against the wavelengths between 390nm and 460nm thus covering the most dangerous zone of «blue light» and maintaining scotopic vision (over 460nm) Bi-Flex M yellow filter Page 10 March 2017 Medicontur Vision of Expertise

11 SUMMARY: MEDICONTUR HYDROPHILIC IOLs; MATERIAL - BENZ 25 MAIN CHARACTERISTICS RI 46 ABBE NUMBER 58 BLUE LIGHT FILTER ASPHERICITY OPTIC ANGULATION SE MANUFACTURING PROCESS TECHNOLOGY YES; nm (violett) Neutral Biconvex; Aspheric; Aberration free 0 ; posterior vaulting 360 ; 10um LATHE CUT POLISH FREE Page 11 March 2017 Medicontur Vision of Expertise

12 Material HYDROPHOBIC Page 12 March 2017 Medicontur Vision of Expertise

13 HYDROPHOBICITY & CONTACT ANGLE in NATURE Low Contact angle High Good Adhesiveness Poor Good Wettability Poor High Solid Surface Free Energy Low Page 13 March 2017 Medicontur Vision of Expertise

14 SEMTE MEDICONTUR DEVELOPMENT 2008 MEDICONTUR developed SEMTE as the 2nd generation of hydrophobic material 2010 officially launched 1st implantation of IOLs February 2010, Germany SPNSO Berkeley/USA EMTE S E M T E Soft Ethyl-Methyl-Tri-Ethylacrylate Page 14 March 2017 Medicontur Vision of Expertise

15 SEMTE = GLISTENING FREE GLISTENING = fluid filled vacuoles that form within the matrix of the lens when exposed to an aqueous environment Affects Visual Acuity and Contrast Sensitivity Mechanism unclear Refractive Index (lower the better, aim: close to RI crystalline lens) Manufacturing (Cast molded) Non Compatible packaging Differences between hydrophobic materials Glistening Acrysof Hoya No glistening reported: (all RI close to crystalline lens) Tecnis Aurolab Hanita (Benz Research) Medicontur Page 15 March 2017 Medicontur Vision of Expertise Glistening in HB IOL (Alcon) (Courtesy by Michael Assouline, MD, PhD)

16 REFRACTIVE INDEX AT DIFFERENT HYDROPHOBIC IOLs ON THE MARKET Refractive index 1,55 1,545 1,54 1,52 1,49 1,47 1,47 1,43 Page 16 March 2017 Medicontur Vision of Expertise

17 GLASS TRANSITION TEMPERATURE of the MATERIAL (Tg) The mechanical parameters of hydrophobic IOL polymers are dependent on the glass transition temperature of the material Tg: the temperature at which the polymer transforms from a rigid glassy polymer to a flexible compliant material - room temperature for PMMA - below room temperature (22 C) for hydrophobic material, ensuring easy manipulation such as flexing and rolling - at lower operating room (OR) temperatures, some hydrophobic acrylic materials with higher Tg values can behave as rigid materials, in which case folding and compressing are more challenging - Lower Tg, better manipulation/softer in OR Page 17 March 2017 Medicontur Vision of Expertise

18 CHROMATIC ABBERATION = Uneven focusing of an optical system that causes different wavelengths of light to have different focal points, thus decreasing optical performance Graphs shows association of RI & ABBE number Refractive index: n E = 1.46 (546 nm, 35 C) ABBE BENZ25 = 58 Page 18 March 2017 Medicontur Vision of Expertise

19 CHROMATIC ABBERATION 2 Dpt Page 19 March 2017 Medicontur Vision of Expertise

20 ABBE NUMBER How Do We Measure Chromatic Aberration? Ernst Abbe ( ) the German physicist The Abbe number is a measure of the material's dispersion (variation of refractive index with wavelength) in relation to the refractive index. Low dispersion (low chromatic aberration) materials have high values of V. The higher the Abbe number the lower the chromatic aberration and the higher the retinal image Quality Page 20 March 2017 Medicontur Vision of Expertise Zhao H., Mainster M. JCRS Negishi K, et al. Arch Ophthalmol 2001.

21 HYDROPHOBIC MATERIALs & Its ABBE NUMBER Zhao H., Mainster M. JCRS Negishi K, et al. Arch Ophthalmol Page 21 March 2017 Medicontur Vision of Expertise

22 HYDROPHOBIC MATERIALS MAY IMPROVE OR WORSEN CHROMATIC ABBERATION Dioptric shift (colour components of white light) 2,21 2 1,72 Alcon Crisalline lens Medicontur Worsening Improvement Page 22 March 2017 Medicontur Vision of Expertise

23 Chromatic aberration of the eye: to correct or not to correct? Page 23 March 2017 Medicontur Vision of Expertise

24 The results of our Optics Express paper suggest than an IOL that corrects both spherical and chromatic aberrations by combining aspheric and diffractive elements may have the potential to provide an improvement in the quality of vision in patients after cataract surgery. Proff. Pablo Artal is the founder and director of the Laboratorio de Optica at the University of Murcia. Visual effect of the combined correction of spherical and longitudinal chromatic aberrations Pablo Artal, Silvestre Manzanera, Patricia Piers, and Henk Weeber Optics Express, Vol. 18, Issue 2, pp (2010) doi: /oe Page 24 March 2017 Medicontur Vision of Expertise

25 the correction of chromatic aberration can improve visual acuity Proff. Pablo Artal, the founder and director of the Laboratorio de Optica at the University of Murcia.. Page 25 March 2017 Medicontur Vision of Expertise

26 MEDICONTUR SEMTE : AN INNOVATIVE HYDROPHOBIC MATERIAL MAIN CHARACTERISTICs RI 47 ABBE 57 BLUE LIGHT FILTER ASPHERICITY SE YES; nm Neutral 360 ; 10 um Tg (lowest on the market) 4 C Glistening Manufacturing Process Glistening Free Cryolathing Page 26 March 2017 Medicontur Vision of Expertise

27 HYDROPHOBIC MATERIAL (SEMTE ) STRENGHTs Property of the material Clinical evidence Reduced tackiness Low Tg 4 C (lowest on the market) Excellent pseudo-plasticity Unfolding after implantation (similar to HL IOLs) Improved mechanical properties (better manipulation during implantation) Quick centration Perfect SE <10 um 360 Low ratio of PCO Relatively low RI 1.47 Low chromatic aberration (highest Abbe number; 57) Glistening free High optical performance Page 27 March 2017 Medicontur Vision of Expertise

28 IOL manufacturer MAIN CHARACTERISTICs OF HYDROPHOBIC MATERIALs on the MARKET Contact angle with water Packaging Glass Transition Temperature (Tg) Manufacturing method Water content RI ABBE number Alcon 72 Dry C Molding <0.5% Abbot /J&J 88 Dry Cryolathing <0.5% Hoya 85 Dry 11 C Lathe cut <0.3% Hanita (Benz)? Dry 10 C Cryolathing <2.0% (49) Bausch & Lomb (Valeant) 76 Prehydrated in 0.9% C Lathe cut room tem 4.0% 1.54? Cristalens (Artis Luxiol) Zeiss (AARON) (CT LUCIA 601P(Y)) Medicontur Bi-Flex HB (SEMTE)? Dry 11 C Cryolathing <1% 1.545? 88 Dry? Cryolathing 0.3% 1.49? 87 Dry 4 C Cryolathing 0.4% Khiun F. Tjia, MD; Catarct & Refractive Surgery today Europe, August 2010 Page 28 March 2017 Medicontur Vision of Expertise

29 OPTIMAL IOL BALANCED TECHNOLOGY Material Design Optic Page 29 March 2017 Medicontur Vision of Expertise

30 OPTIMAL IOL BALANCED TECHNOLOGY Design The most important element of a successful IOL is the lens design. IOL must fit properly so that it is stable in the long term, with minimal potential for decentration. Additionally, IOL design is a key factor in inhibiting PCO. Richard L. Lindsrom, MD MEDICONTUR Bi-FLEX PLATFORM OPTIC: 6/13mm DOUBLE-LOOP HAPTICs Page 30 March 2017 Medicontur Vision of Expertise

31 Made by TNN SHARP EDGE WHAT IS PERFECT SHARP EDGE? Intraocular lenses with a radius curvature of less than 10.0 microns appear to have good PCO protection Mayank et al; JCRS; vol.34; 2008 Medicontur Bi-Flex & all Flex platforms SE 10 microns Page 31 March 2017 Medicontur Vision of Expertise

32 MEDICONTUR Bi-FLEX SQUARE EDGE MUST BE PRESENT AT 360 Geometry of the lens with a square posterior optic edge is the most important factor. This feature should be present in 360 around the optic, as the optic-haptic junction of single piece lenses may represent sites where the edge barrier effect is absent Werner L., Biocompatibility of intraocular lens materials; 2008 Wolters Kluwer Health Alcon Acrysof Achilles heel around haptic the source of PCO Page 32 March 2017 Medicontur Vision of Expertise

33 COMPARISON IN DIFFERENT IOLs in OPTIC-HAPTIC JUNCTION Bi Flex 677ABY 10 microns Comp 1 35 microns Comp 2 60 microns Comp 3 25 microns Page 33 March 2017 Medicontur Vision of Expertise

34 COMPARISON IN DIFFERENT IOLs in OPTIC-HAPTIC JUNCTION No Square Edge at all at Optic-Haptic Junctions Comp 4 Comp 5 Comp 6 Page 34 March 2017 Medicontur Vision of Expertise

35 SQUERE EDGE HAS NOT THE SAME MEANING AT DIFFERENT PRODUCERS Measurement of radii of Square Edge (SE) at optic-haptic junction by Scanning Electron Microscopy. The IOLs with discontinuity of SE in optic-haptic junction are not included 60 The smaller the radius, The more effective the square edge effect *Comp = Competitor Page 35 March 2017 Medicontur Vision of Expertise

36 Made by TNN POLISH FREE TECHNOLOGY Maintaining perfect SE Hydrophilic intracapsular IOLs Hydrophilic material more difficult to maintain SE of IOLs because of the hydratation process during production POLISH FREE technology significantly enhancing of SE of IOLs Preventing PCO development Polishing free surface Page 36 March 2017 Medicontur Vision of Expertise

37 180 CONTACT BETWEEN THE LOOPS & CAPSULA The specific Bi-Flex closed-loop haptic design offers adequate resistance to a shrinking capsular bag haptics that do not overlap excellent axial stability optimal filling up of the capsular bag unmatched centration and stability Bi-Flex design in a rigid ring cap No loo en Page 37 March 2017 Medicontur Vision of Expertise

38 180 CONTACT BETWEEN THE LOOPS & CAPSULAR BAG EQUATOR A unique & patented design Experimental simulator with a diameter of 9 mm Medicontur Bi-Flex Average contact angle: 88.8 Competitor 1 Average contact angle: 69 Competitor 2 Average contact angle: 64.4 Page 38 March 2017 Medicontur Vision of Expertise

39 OPTIMAL IOL BALANCED TECHNOLOGY Material Design Optic Page 39 March 2017 Medicontur Vision of Expertise

40 OPTIMAL IOL BALANCED TECHNOLOGY Optic Optical performance is critical. If the IOL does not provide the patient with a satisfactory optical outcome, then the IOL fails from the start. Louis D. Nichamin, MD Page 40 March 2017 Medicontur Vision of Expertise

41 ABERRATIONs An ABERRATION is a departure of an image-forming optical system from ideal behaviour Chromatic aberration are caused by dispersion (the variation of index of refraction of a medium with wavelenght Longitidunal Lateral Monochromatic aberration are caused by geometry (the shape of teh lens) Spherical aberration Coma Distortion Astigmatism Field curvature Page 41 March 2017 Medicontur Vision of Expertise

42 SPHERICAL ABERRATION - BASICS Optical aberration when light rays travel through the edges of the lens, and light rays do not intersect in one focal point Positive, Negative aberration and Aberration-free lenses Zernike polynomials are widely used in ophthalmology to characterize wavefront aberrations. The most significant parameter is the Z(4,0) which describes the spherical aberration. For example: Vertical tilt Astigmatism Horizontal coma Spherical aberration Superimposed wavefront = 42 Page 42 March 2017 Medicontur Vision of Expertise

43 SPHERICAL ABERRATION Young eye: Negative spherical aberration of the young crystalline lens balances Positive spherical aberration of the cornea* Essentially zero spherical aberration at the age of 19** With age: Functional vision is reduced as the aging crystalline lens loses the ability to compensate for corneal spherical aberration* The Young Lens Aberration in the Aging Lens Not drawn to scale Not drawn to scale *Guirao A, et al. J Opt Soc Am A. 2000;17: **Holzer M. Presented at DOC, Page 43 March 2017 Medicontur Vision of Expertise

44 Positive spherical aberration Several focal points Human cornea: SA Aberration-free One focal point Medicontur s IOLs Negative spherical aberration Competitors IOLs Several focal points Page 44 March 2017 Medicontur Vision of Expertise

45 SPHERICAL ABERRATION - IN THE EYE The avarege human cornea has μm spherical aberration [1] The human crystalline lens has a small negative spherical aberration [2] With age, the positive aberration of the lens increases [3] - blurred vision, reduce contrast sensitivity Page 45 March 2017 Medicontur Vision of Expertise

46 COMPETITORS IOLs Spherical aberration with a 6.0 mm pupil Medicontur IOLs 0.00 μm Aberration-free Bauch&Lomb / SofPort AO 0.00 μm Aberration-free Rayner / C-felx, Superflex 0.00 μm Aberration-free PhysIOL IOLs μm Negative SA Alcon / AcrySof IQ μm Negative SA Zeiss / Acri.Smart μm Negative SA AMO / Tecnis μm Negative SA Table: Spherical aberration of aspheric IOLs. [6] Page 46 March 2017 Medicontur Vision of Expertise

47 SPHERICAL ABERRATION - IN THE EYE SA depends on pupil size: The wider the pupil the higher the SA (scotopic vision)[4] Depth of focus: - Reduction of aberrations may reduce depth of focus with aspheric IOLs[6] - Difference in spherical aberrations of up to 20 µm does not produce a clinically significant difference in depth of focus[5] Page 47 March 2017 Medicontur Vision of Expertise Depth of focus (DOF) is the distance in between the object can be moved backward and forward and still appear acceptably sharp in an image..

48 NEUTRAL ASPHERICITY APPROACH Without precise wavefront analysis the aberration of the cornea itself is unknown. So the implantation of an IOL with a negative aberration can result in a drastic decrease in depth of field. Neutral approach, the aberration-free IOLs are the best options in these cases. Page 48 March 2017 Medicontur Vision of Expertise

49 REFERENCES [1] Distribution of corneal spherical aberration in a comprehensive ophthalmology practice and whether keratometry can predict aberration values; George H.H. Beiko, BM, BCh, FRCS(C), Wolfgang Haigis, MS, PhD, Andreas Steinmueller, MS; J Cataract Refract Surg 2007;33: [2] The spherical aberration of the crystalline lens of the human eye; George Smith, Michael J. Cox, Richard Calver, Leon F. Garner; Vision Research 41 (2001) [3] Aspheric IOLs can improve image quality for cataract surgery patients; Uday Devgan, MD, FACS; healio article [4] C constant: New concept for ray tracing assisted intraocular lens power calculation; Thomas Olsen, MD, PhD, Peter Hoffmann, MD; J Cataract Refract Surg 2014; 40: [5] Fellow-eye comparison of 2 aspheric microincision intraocular lenses and effect of asphericity on visual performance; Mayank A. Nanavaty, DO, MRCOphth, MRCS(Ed), David J. Spalton, FRCP, FRCS, FRCOphth, Kavita B. Gala, DO; J Cataract Refract Surg 2012; 38: [6] Wavefront aberrations, depth of focus, and contrast sensitivity with aspheric and spherical intraocular lenses: Fellow-eye study; Mayank A. Nanavaty, DO, MRCOphth, MRCSEd, David J. Spalton; Cataract Refract Surg 2009; 35: [7] Analysis of the possible benefits of aspheric intraocular lenses: Review of the literature; Robert Monte s-mico, OD, MPhil, PhD, Teresa Ferrer-Blasco, OD, MSc, PhD, Alejandro Cervin o, OD, PhD; J Cataract Refract Surg 2009; 35: Page 49 March 2017 Medicontur Vision of Expertise

50 Medicontur IOLs: Materials & Design OBJECTIVE HANDLING How to manage competition with confidence

51 My doctor does not want to use hydrophilic IOLs since hydrophilic material is less stable with often calcification/opacification There are many hydrophilic IOL materials on the market DIFFERENT MATERIALs DIFFERENT TECHNOLOGIEs & DIFFERENT QUALITY IMPORTANT! Distillation of monomers before polymerisation is CRUTIAL for PURITY Disadvantage: 10% of material loss BUT Advantage: clean, safe material; less prone to opacification and calcification inside a lens other companies e.g. Contamac produce without distillation process Page 51 March 2017 Medicontur Vision of Expertise

52 PROOF: since year 1999 over HL IOLs have been sold & implanted LOOK AT THE TREND IN PREMIUM MULTIFOCAL IOLs: 2016 DP AREA STATISTICs SAFE and HIGH QUALITY HL IOLs are appreciated by surgeons Medicontur uses the same HL material - BENZ 25 (USA); as well as Zeiss & Physiol. 48% 52% HIGH STANDARDS FOR PRODUCTION AT MEDICONTUR DO NOT FORGET: HL material = BETTER UVEAL BIOCOMPATIBILITY HB Multifocal HL Multifocal Page 52 March 2017 Medicontur Vision of Expertise

53 My doctor does not want to use hydrophilic IOLs since hydrophilic IOLs have higher PCO rate than HB Statistically PCO occurs sooner and more often in hydrophilic IOLs. But based on many studies PCO depends on rather design than the material. PCO rate finally makes a difference in outcomes and patient satisfaction especially important in case of multifocal IOLs. The best optical offer will suffer from capsular fibrosis Yag laser: the later the better Additionally, IOL design is a key factor in inhibiting PCO. Richard L. Lindsrom, MD Page 53 March 2017 Medicontur Vision of Expertise

54 DESIGN (SE) rather than material is crucial for protection of PCO development Recent work has shown that the IOL should have a crisp square edge to be effective and electron microscope shows that although IOLs are sold with a square edge profile there is in fact a great deal of difference in edge quality between companies. It is relatively easy to get a crisp edge oh hydrophobic polymers but more difficult with the hydrophilic materials used by many smaller companies. This is because hydrophilic materials are machined in a dehydrated state and then rehydrated for clinical use. In this process the lenses lose some of their edge quality. This explains why hydrophilic IOLs tend to get more PCO. Another factor of relevance is that, ideally the IOL should have a 360 SE and unfortunately many IOLs have a breach in the edge where optic and haptics meet, causing the so called Achilles heel effect in the barrier.. Spalton D:Latest Development in intraocular lenses. 09/10 CET; p. 28 The higher incidence of PCO with hydrophilic materials may also be due to the fact that the optic edge with hydrophilic materials is not as sharp as with hydrophobic materials. Nanavaty MA, Spalton DJ, Boyce J, et al. Edge profile of commercially available square-edged intraocular lenses. J Cataract Refract Surg.2008;34(4): Page 54 March 2017 Medicontur Vision of Expertise

55 Clinical proof: Bellucci et al.: ESCRS 2014: Same design hydrophobic and hydrophilic intraocular lenses: intra-individual comparison Prospective study; 25 patients; the Medicontur 677 AB IOL in one eye (hydrophilic), and the 877 AB IOL in the contralateral eye (hydrophobic). The two lenses share the same design and sharp posterior edge. Follow up to 30 months Results: Visual acuity and refraction did not vary between IOLs. Posterior capsule opacification was very low in this series, and slightly worse for the hydrophobic model. To-date, 3 eyes with the hydrophilic model and 2 eyes with the hydrophobic model underwent laser posterior capsulotomy. Page 55 March 2017 Medicontur Vision of Expertise

56 Clinical proof: WESCR 2014:Helena Gerbec: First results with Medicontur Bi-flex 677AB hydrophilic aspheric IOL Retrospective review of 856 eyes of 642 patients Follow-up: 33 months: Indications for YAG capsulotomy: BCVA =/< 0,7 and PCO (Health Insurance Institute of Slovenia standard) or BCVA reduction by >20% and PCO RESULTS: PCO and YAG capsulotomy: 9 eyes (5 patients) - 1% Page 56 March 2017 Medicontur Vision of Expertise

57 Clinical proof: 1. Bi- Flex-M (HL): 150 consecutive patients (=300 eyes) 1 year follow up; YAG = 0 2. Bi-Flex T (HL): 30 eyes; 1 year follow-up; YAG =0 1. Dexl et al.: ESCRS 2014:Visual Outcome, Patient Satisfaction and Spectacle Independency after Implantation of Progressive Bi-Flex M. Final Result of a Multicentric study. 2. AF Dunai, K Kranitz, E Juhasz, G Sandor, T Filkorn, ZZs Nagy. Comparison of two multifocal IOL types short and medium-term visual outcomes 3. Gyori J.: Long term functional and morphological outcomes and patient satisfaction after cataract surgery with Bi-Flex M implantation with / without posterior central circular capsulorhexis (PCCC). 4. A. Bachenger, T.Rückl, W.Riha, G. Grabner, A.Dexl: Rotational stability and visual outcome after implantation of a new toric intraocular lens for the correction of corneal astigmatism during cataract surgery. J Cataract Surgery 2013: Page 57 March 2017 Medicontur Vision of Expertise

58 My doctor tells that SE is not a issue today, since all companies today have SE YES, it is true. Almost all companies claim their IOLs have sharp edge. BUT WHAT IS PERFECT SHARP EDGE? Intraocular lenses with a radius curvature of less than 10.0 microns appear to have good PCO protection Mayank et al; JCRS; vol.34; 2008 Medicontur Flex platform SE 10 microns Page 58 March 2017 Medicontur Vision of Expertise

59 MEDICONTUR Bi-FLEX SQUARE EDGE MUST BE PRESENT AT 360 Geometry of the lens with a square posterior optic edge is the most important factor. This feature should be present in 360 around the optic, as the optic-haptic junction of single piece lenses may represent sites where the edge barrier effect is absent Werner L., Biocompatibility of intraocular lens materials; 2008 Wolters Kluwer Health Alcon Acrysof Achilles heel around haptic the source of PCO Page 59 March 2017 Medicontur Vision of Expertise

60 DO ALL COMPANIES HAVE REAL & PERFECT SE? NO Recent work has shown that the IOL should have a crisp square edge to be effective and electron microscope shows that although IOLs are sold with a square edge profile there is in fact a great deal of difference in edge quality between companies Nanavaty MA, Spalton DJ, Boyce J, et al. Edge profile of commercially available square-edged intraocular lenses. J Cataract Refract Surg., 2008;34(4): Spalton D:Latest Development in intraocular lenses. 09/10 CET; p. 28 Page 60 March 2017 Medicontur Vision of Expertise

61 CLINICAL PROOF:COMPARISON IN DIFFERENT IOLs in OPTIC- HAPTIC JUNCTION Bi Flex 677ABY 10 microns Comp 1 35 microns Comp 2 60 microns Comp 3 25 microns Page 61 March 2017 Medicontur Vision of Expertise

62 CLINICAL PROOF:COMPARISON IN DIFFERENT IOLs in OPTIC- HAPTIC JUNCTION No Square Edge at all at Optic-Haptic Junctions Comp 4 Comp 5 Comp 6 Page 62 March 2017 Medicontur Vision of Expertise

63 CLINICAL PROOF: SHARP EDGE HAS NOT THE SAME MEANING AT DIFFERENT COMPETITORs Measurement of radii of Square Edge (SE) at optic-haptic junction by Scanning Electron Microscopy. The IOLs with discontinuity of SE in optic-haptic junction are not included 60 The smaller the radius, The more effective the square edge effect *Comp = Competitor Page 63 March 2017 Medicontur Vision of Expertise

64 My doctor tells that PCO is not a problem since it can be easily treated by Nd: YAG laser capsulotomy Yes, it is true, BUT YAG capsulotomy may lead to other complications, including a short-term increase in intraocular pressure, ocular inflammation, cystoid macular edema, and retinal detachment. Besides, Nd:YAG laser capsulotomy does not improve visualization of the peripheral retina, increases the overall costs for cataract treatment, and is not available in large parts of the developing world. Page 64 March 2017 Medicontur Vision of Expertise

65 Clinical proofs: IATROGENICITY OF Nd:YAG CAPSULOTOMY HAS BEEN DESCRIBED IN CLINICAL OBSERVATIONs REFRACTION 7% of eyes experienced a significant change in subjective refraction Effect of Nd:YAG laser capsulotomy on refraction in multifocal apodized diffractive pseudophakia. Vrijman V.:JRefract Surg Aug;28(8): doi: / X MACULAR CHANGES Thirty eyes of 30 patients with posterior capsule opacification following phacoemulsification were enrolled in the study. Patients were classified according to total energy used during Nd:YAG laser capsulotomy ( 80 mj = group I, > 80 mj = group II). RESULTS: In group I, IOP increased 1 week postoperatively (P =.007) and declined to preoperative levels at 1 month. In group II, IOP increased 1 week postoperatively (P =.001) and did not return to preoperative levels during 3 months of follow-up (P =.04). Both groups had increased macular thickness compared to preoperative levels, but group II measurements were significantly higher 1 week and 1 month postoperatively compared to group I (P =.004 and.03, respectively). ARI S, Ophthalmic Surg Lasers Imaging Sep: The Effects of Nd:YAG Laser Posterior Capsulotomy on Macular Thickness, Intraocular Pressure, and Visual Acuity. Page 65 March 2017 Medicontur Vision of Expertise

66 THANK YOU FOR NOTICING ALL DISCUSSED FACTs