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Medicontur IOLs: Materials & Design Main Characteristics

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  • Medicontur IOLs: Materials & Design

    Main Characteristics

  • Page 2 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    Material

    OpticDesign

    BALANCED TECHNOLOGY FOR OPTIMAL IOLs

    OPTICAL

    PERFORMANCE

    STABILITY IN THE

    EYE

    LOW PCO RATE

    LONG TERM

    MATERIAL

    PERFORMANCE

    REFRACTIVE

    STABILITY

    TECHNOLOGY

  • Page 3 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    MEDICONTUR IOL PORTFOLIO

    Hydrophilic IOLs

    (25% and 26% water content, clear & yellow)

    • Advanced monofocal IOLs (aspheric – neutral

    approach)

    • Premium Toric

    • Premium Multifocal

    • Premium Multifocal-Toric

    • SML & Add-On IOLs

    Hydrophobic IOLs

    (clear & yellow)

    • Advanced monofocal aspheric IOLs

    • Proprietary SEMTE material with the

    highest ABBE number (58); Tg (4°C)

    • On the market since 2009

  • Page 4 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    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 5 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    Material

    OpticDesign

    OPTIMAL IOL – BALANCED TECHNOLOGY

  • Page 6 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    HYDROPHILIC

    Material

  • Page 7 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    HYDROPHILIC BENZ 25 (USA)

    • There are many hydrophilic IOL materials on the market

    DIFFERENT MATERIALs

    DIFFERENT TECHNOLOGIEs &

    DIFFERENT QUALITY

    Medicontur uses BENZ 25, USA (as well as Zeiss, Physiol….)

    IMPORTANT!

    Distillation of monomers before polymerisation

    • 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 8 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    EOEMA

    36%

    HEMA

    64%

    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

    HYDROPHILIC BENZ 25

  • Page 9 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    Apart from design, polimer chain length has a

    proven effect against cell adhesion :

    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

    Anti-PCO behaviour

    Hydrogel MMA 26%

    MEDICONTUR HYDROPHILIC – BENZ 25

  • Page 10 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    • 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

    NATURAL YELLOW FILTER

  • Page 11 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    SUMMARY: MEDICONTUR HYDROPHILIC IOLs; MATERIAL - BENZ 25

    MAIN CHARACTERISTICS

    RI 46

    ABBE NUMBER 58

    BLUE LIGHT FILTER YES; 390-460nm (violett)

    ASPHERICITY Neutral

    OPTIC Biconvex; Aspheric;

    Aberration free

    ANGULATION 0°; posterior vaulting

    SE 360°; 10um

    MANUFACTURING PROCESS LATHE CUT

    TECHNOLOGY POLISH FREE

  • Page 12 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    HYDROPHOBIC

    Material

  • Page 13 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    Low Contact angle High

    Good Adhesiveness Poor

    Good Wettability Poor

    High Solid Surface Free

    Energy

    Low

    HYDROPHOBICITY & CONTACT ANGLE in NATURE

  • Page 14 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    SPNSO

    Berkeley/USA

    EMTE S E M T E

    Soft Ethyl-Methyl-Tri-Ethylacrylate

    • 2008 MEDICONTUR developed SEMTE as the 2nd generation of hydrophobic material

    • 2010 – officially launched

    • 1st implantation of IOLs – February 2010, Germany

    www.assouline.info

    SEMTE – MEDICONTUR DEVELOPMENT

  • Page 15 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    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 unclearRefractive Index (lower the better, aim: close to RI crystalline lens)

    Manufacturing (Cast molded)

    Non Compatible packaging

    Differences between hydrophobic materialsGlistening

    Acrysof

    Hoya

    No glistening reported: (all RI close to crystalline lens)Tecnis

    Aurolab

    Hanita (Benz Research)

    Medicontur

    Glistening in HB IOL (Alcon)

    (Courtesy by Michael Assouline, MD, PhD)

  • Page 16 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    1,55 1,5451,54

    1,52

    1,49

    1,47 1,47

    1,43

    Refractive index

    REFRACTIVE INDEX AT DIFFERENT HYDROPHOBIC IOLs ON THE MARKET

  • Page 17 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    GLASS TRANSITION TEMPERATURE of the MATERIAL (Tg)

    The mechanical parameters of hydrophobic IOLpolymers are dependent on the glasstransition temperature of the material

    Tg: the temperature at which the polymertransforms from a rigid glassy polymer to aflexible compliant material

    - room temperature for PMMA

    - below room temperature (22° C) forhydrophobic material, ensuring easymanipulation such as flexing and rolling - atlower operating room (OR) temperatures, somehydrophobic acrylic materials with higher Tgvalues can behave as rigid materials, in whichcase folding and compressing are morechallenging

    - Lower Tg, better manipulation/softer in OR

  • Page 18 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    = Uneven focusing of an optical system that causes

    different wavelengths of light to have different focal points,

    thus decreasing optical performance

    Refractive index: nE = 1.46 (546 nm, 35 °C)ABBEBENZ25 = 58

    CHROMATIC ABBERATION

    Graphs shows association of RI & ABBE number

  • Page 19 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    2 Dpt

    CHROMATIC ABBERATION

  • Page 20 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    ABBE NUMBER

    How Do We Measure Chromatic Aberration?

    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

    .

    Zhao H., Mainster M. JCRS. 2007 2. Negishi K, et al. Arch Ophthalmol 2001.

    Ernst Abbe (1840–1905) the German physicist

  • Page 21 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    1.Zhao H., Mainster M. JCRS. 2007 2. Negishi K, et al. Arch Ophthalmol 2001.

    HYDROPHOBIC MATERIALs & Its ABBE NUMBER

    0

    10

    20

    30

    40

    50

    60

    3742 43

    47

    55 57

  • Page 22 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    Alcon Crisalline lens Medicontur

    2,212

    1,72

    Dioptric shift (colour components of white light)

    Worsening Improvement

    HYDROPHOBIC MATERIALS MAY IMPROVE OR WORSEN CHROMATIC

    ABBERATION

  • Page 23 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    Chromatic aberration of the eye: to correct or not to correct?

  • Page 24 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    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. 1637-1648 (2010) doi:10.1364/OE.18.001637

  • Page 25 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    „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 26 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    MEDICONTUR – SEMTE : AN INNOVATIVE HYDROPHOBIC MATERIAL

    MAIN CHARACTERISTICs

    RI 47

    ABBE 57

    BLUE LIGHT FILTER YES; 380-510 nm

    ASPHERICITY Neutral

    SE 360°; 10 um

    Tg (lowest on the market) 4°C

    Glistening Glistening Free

    Manufacturing Process Cryolathing

  • Page 27 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    HYDROPHOBIC MATERIAL (SEMTE ) – STRENGHTs

    Property of the material Clinical evidence

    Reduced tackiness

    Unfolding after implantation

    (similar to HL IOLs)

    Low Tg – 4°C

    (lowest on the market)

    Improved mechanical properties

    (better manipulation during implantation)

    Excellent pseudo-plasticity Quick centration

    Perfect SE

  • Page 28 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    MAIN CHARACTERISTICs OF HYDROPHOBIC MATERIALs on the MARKET

    IOL

    manufacturer

    Contact angle

    with water

    Packaging Glass Transition

    Temperature (Tg)

    Manufacturing

    method

    Water

    content

    RI ABBE

    number

    Alcon 72° Dry 14.0-15.5°C Molding

  • Page 29 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    Material

    OpticDesign

    OPTIMAL IOL – BALANCED TECHNOLOGY

  • Page 30 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    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

    OPTIMAL IOL – BALANCED TECHNOLOGY

    MEDICONTUR Bi-FLEX PLATFORM

    OPTIC: 6/13mm

    DOUBLE-LOOP HAPTICs

  • Page 31 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com | Ma

    de

    by

    TN

    N

    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

    SHARP EDGE

  • Page 32 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    „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

    ME

    DIC

    ON

    TU

    R B

    i-F

    LE

    XSQUARE EDGE MUST BE PRESENT AT 360°

  • Page 33 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    Comp 3

    25 microns

    Comp 2

    60 microns

    Comp 1

    35 microns

    Bi Flex 677ABY

    10 microns

    COMPARISON IN DIFFERENT IOLs in OPTIC-HAPTIC JUNCTION

  • Page 34 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    Comp 5 Comp 6Comp 4

    No Square Edge at all

    at

    Optic-Haptic

    Junctions

    COMPARISON IN DIFFERENT IOLs in OPTIC-HAPTIC JUNCTION

  • Page 35 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    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

    The smallerthe radius,

    The more effectivethe square edge effect

    60

    35

    25 25 2520 10

    *Comp = Competitor

    SQUERE EDGE HAS NOT THE SAME MEANING AT DIFFERENT PRODUCERS

  • Page 36 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com | Ma

    de

    by

    TN

    N

    Polishing free surface

    • 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

    POLISH FREE TECHNOLOGY

  • Page 37 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    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

    90°

    90°

    B i-F LE X

    Bi-Flex design in a rigid ring

    91°contact angle with simulation of rigid capsular sac of 9.0 mm diameter.

    Note the good contact (homogeneous) of the loops with the capsular equator for their entire length.

    In total Bi-Flex has more than

    180°contact angle

    between its loops

    and the capsular bag.

    180° CONTACT BETWEEN THE LOOPS & CAPSULA

  • Page 38 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    Medicontur Bi-Flex Average contact angle: 88.8°

    Competitor 1Average contact angle: 69°

    Experimental simulator with a diameter of 9 mm

    Competitor 2 Average contact angle: 64.4°

    A unique & patented design

    180° CONTACT BETWEEN THE LOOPS & CAPSULAR BAG EQUATOR

  • Page 39 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    Material

    OpticDesign

    OPTIMAL IOL – BALANCED TECHNOLOGY

  • Page 40 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    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

    OPTIMAL IOL – BALANCED TECHNOLOGY

  • Page 41 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    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

    ABERRATIONs

  • Page 42 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    SPHERICAL ABERRATION - BASICS

    42

    + + + =

    Vertical

    tiltAstigmatism Horizontal

    coma

    Spherical

    aberration

    Superimposed

    wavefront

    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:

  • Page 43 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    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*

    *Guirao A, et al. J Opt Soc Am A. 2000;17:1697-1702. **Holzer M. Presented at DOC, 2006.

    -+ + +

    The Young Lens Aberration in the Aging Lens

    Not drawn to scale Not drawn to scale

    SPHERICAL ABERRATION

  • Page 44 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    Positive spherical aberration

    Aberration-free

    Negative spherical aberration

    One focal point

    Several focal points

    Several focal points

    Human cornea: +0.27 SA

    Medicontur’s IOLs

    Competitors’ IOLs

  • Page 45 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    The avarege human cornea has +0.27 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

    SPHERICAL ABERRATION - IN THE EYE

  • Page 46 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    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 - 0.11 μm Negative SA

    Alcon / AcrySof IQ - 0.20 μm Negative SA

    Zeiss / Acri.Smart - 0.26 μm Negative SA

    AMO / Tecnis - 0.27 μm Negative SA

    Table: Spherical aberration of aspheric IOLs. [6]

  • Page 47 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    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]

    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. .

    SPHERICAL ABERRATION - IN THE EYE

  • Page 48 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    NEUTRAL ASPHERICITY APPROACH

    Without precise wavefront analysis the aberration of thecornea itself is unknown. So the implantation of an IOL

    with a negative aberration can result in a drasticdecrease in depth of field.

    Neutral approach, the aberration-free IOLs are the bestoptions in these cases.

  • Page 49 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    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;33:848–858

    [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) 235–243

    [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; 40:764–773

    [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; 38:625–632

    [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; 35:663–671

    [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; 35:172–181

  • Medicontur IOLs: Materials & Design

    OBJECTIVE HANDLING

    How to manage competition with confidence

  • Page 51 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    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 52 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    LOOK AT THE TREND IN PREMIUM MULTIFOCAL IOLs:

    2016 – DP AREA STATISTICs

    PROOF: since year 1999 over 4.000.000 HL IOLs have been sold & implanted

    52%48%

    HB Multifocal

    HL Multifocal

    Medicontur uses the same HL material - BENZ 25 (USA);

    as well as Zeiss & Physiol.

    HIGH STANDARDS FOR PRODUCTION AT MEDICONTUR

    SAFE and HIGH QUALITY HL IOLs are appreciated by surgeons

    DO NOT FORGET:

    HL material = BETTER UVEAL BIOCOMPATIBILITY

  • Page 53 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    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 54 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    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):677-686.

    DESIGN (SE) rather than material is crucial for protection of PCO development

  • Page 55 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    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.

    Clinical proof: Bellucci et al.: ESCRS 2014: Same design hydrophobic and hydrophilic

    intraocular lenses: intra-individual comparison

  • Page 56 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    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 57 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    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:

    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

  • Page 58 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    Medicontur „Flex“ platform

    SE 10 microns

    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

  • Page 59 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    Alcon Acrysof – „Achilles heel“ around haptic – the source of

    PCO

    ME

    DIC

    ON

    TU

    R B

    i-F

    LE

    XSQUARE 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

  • Page 60 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    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):677-686.

    Spalton D:Latest Development in intraocular lenses. 09/10 CET; p. 28

  • Page 61 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    Comp 3

    25 microns

    Comp 2

    60 microns

    Comp 1

    35 microns

    Bi Flex 677ABY

    10 microns

    CLINICAL PROOF:COMPARISON IN DIFFERENT IOLs in OPTIC-

    HAPTIC JUNCTION

  • Page 62 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    Comp 5 Comp 6Comp 4

    No Square Edge at all

    at

    Optic-Haptic

    Junctions

    CLINICAL PROOF:COMPARISON IN DIFFERENT IOLs in OPTIC-

    HAPTIC JUNCTION

  • Page 63 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    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

    The smallerthe radius,

    The more effectivethe square edge effect

    60

    35

    25 25 2520 10

    *Comp = Competitor

    CLINICAL PROOF: SHARP EDGE HAS NOT THE SAME MEANING AT

    DIFFERENT COMPETITORs

  • Page 64 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    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 65 | March 2017 | Medicontur | Vision of Expertise | www.medicontur.com |

    Clinical proofs: IATROGENICITY OF Nd:YAG CAPSULOTOMY HAS

    BEEN DESCRIBED IN CLINICAL OBSERVATIONs

    REFRACTION7% 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. 2012 Aug;28(8):545-50. doi: 10.3928/1081597X-20120723-03.

    MACULAR CHANGESThirty 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. 2012 Sep: The Effects of Nd:YAG Laser Posterior Capsulotomy on Macular

    Thickness, Intraocular Pressure, and Visual Acuity.

  • THANK YOU FOR NOTICING ALL DISCUSSED

    FACTs