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PHACO ERSATZ

PHACO ERSATZ. HOW AND WHY DID IT START ? WHERE DO WE GO? FRANK JOSEPH GOES frank@goes.be Antwerp-Belgium . PHACO ERSATZ WHAT DOES IT MEAN?????. REPLACING T HE NATURAL LENS OF A 60 YEARS OLD BY AN ARTIFICIAL LENS PERFORMING LIKE A 2O YEARS OLD.

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PHACO ERSATZ

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  1. PHACO ERSATZ • HOW AND WHY DID IT START ? • WHERE DO WE GO? • FRANK JOSEPH GOES • frank@goes.be • Antwerp-Belgium. ESCRS 2011

  2. PHACO ERSATZ WHAT DOES IT MEAN????? REPLACING THE NATURAL LENS OF A 60 YEARS OLD BY AN ARTIFICIAL LENS PERFORMING LIKE A 2O YEARS OLD ESCRS 2011

  3. WHY SHOULD WE REPLACE THE NATURAL LENS ? ACCOMODATION AGE ESCRS 2011

  4. WHAT IS ACCOMODATION ??? • Describedby HELMHOLTZ1853. • Accommodation is the process by which the eye changes its refractive power to bring objects of regard at different distances into focus. • Duringaccomodationcontraction of the ciliary muscle releases the at rest zonular tensionaround the lens equator and the lens increases in axialthickness and in anterior and posterior diameter. ESCRS 2011

  5. The principle of accommodation was discovered in the 17th century by Scheiner. The theories for presbyopia are generally addressing the age changes in the lens, the lens capsule and/or within the lens support structures. Recent studies have shown that the stiffness of the lens substance increases with age by a factor 1000 to 10000 over a lifetime. ESCRS 2011

  6. . Loss of accommodative amplitude with age. Predicted by lens stiffness changes alone, compared to measured objective accommodative amplitude ESCRS 2011

  7. WITH AGE THE LENS CHANGES • the central thickness of the (disaccommodated) lens increases. • the equatorial diameter of the (disaccommodated)lens does not change • the surface curvatures of the (disaccommodated) lens increase • the lens matrix loses its elasticity • the mechanical properties of the capsular bag change • the thickness of the lens capsule changes. The thickness of the anterior capsule increases • the thickness of the posterior pole shows no change with age and the posterior peripheral thickness decreases • the elasticity of the zonular fibers does not change • there is no change in the number of zonular fibers • the insertion points of the anterior zonular fibers stay fixed in relation to the lens center, but shift in reference to the lens equator • HENK WEEBER ESCRS 2011

  8. IMPORTANCE !!!!PrevalanceRate for Presbyopia: Approx 1 in 11 = 9.00% or 24.5 M.people in USA Read more at http://www.wrongdiagnosis.com/p/presbyopia/stats-country.htm?ktrack=kcplink • /RegionExtrapolatedPrevalencePopulationEstimated UsedPresbyopia in NorthAmerica (ExtrapolatedStatistics) USA 26,428,986 293,655,4051Canada 2,925,708 WARNING! (Details) 32,507,8742Mexico 9,446,363 WARNING! (Details) 104,959,5942Presbyopia in Central America (ExtrapolatedStatistics)Belize 24,565 WARNING! (Details) 272,9452Guatemala 1,285,253 WARNING! (Details) 14,280,5962Nicaragua 482,378 WARNING! (Details) 5,359,7592Presbyopia in Caribbean (ExtrapolatedStatistics)PuertoRico 350,816 WARNING! (Details) 3,897,9602Presbyopia in SouthAmerica (ExtrapolatedStatistics)Brazil 16,569,099 WARNING! (Details) 184,101,1092Chile 1,424,156 WARNING! (Details) 15,823,9572Colombia 3,807,969 WARNING! (Details) 42,310,7752Paraguay 557,223 WARNING! (Details) 6,191,3682Peru 2,478,987 WARNING! (Details) 27,544,3052Venezuela 2,251,564 WARNING! (Details) 25,017,3872Presbyopia in Northern Europe (ExtrapolatedStatistics)Denmark 487,205 WARNING! (Details) 5,413,3922Finland 469,306 WARNING! (Details) 5,214,5122Iceland 26,456 WARNING! (Details) 293,9662Sweden 808,776 WARNING! (Details) 8,986,4002Presbyopia in Western Europe (ExtrapolatedStatistics)Britain (United Kingdom) 5,424,363 WARNING! (Details) 60,270,708 for UK2Belgium 931,344 WARNING! (Details) 10,348,2762France 5,438,179 WARNING! (Details) 60,424,2132Ireland 357,260 WARNING! (Details) 3,969,5582Luxembourg 41,642 WARNING! (Details) 462,6902Monaco 2,904 WARNING! (Details) 32,2702Netherlands (Holland) 1,468,637 WARNING! (Details) 16,318,1992United Kingdom 5,424,363 WARNING! (Details) 60,270,7082Wales 262,620 WARNING! (Details) 2,918,0002Presbyopia in Central Europe (ExtrapolatedStatistics)Austria 735,728 WARNING! (Details) 8,174,7622CzechRepublic 112,156 WARNING! (Details) 1,0246,1782Germany 7,418,214 WARNING! (Details) 82,424,6092Hungary 902,913 WARNING! (Details) 10,032,3752Liechtenstein 3,009 WARNING! (Details) 33,4362Poland 3,476,371 WARNING! (Details) 38,626,3492Slovakia 488,121 WARNING! (Details) 5,423,5672Slovenia 181,032 WARNING! (Details) 2,011,473 2Switzerland 670,578 WARNING! (Details) 7,450,8672Presbyopia in Eastern Europe (ExtrapolatedStatistics)Belarus 927,946 WARNING! (Details) 10,310,5202Estonia 120,749 WARNING! (Details) 1,341,6642Latvia 207,567 WARNING! (Details) 2,306,3062Lithuania 324,710 WARNING! (Details) 3,607,8992Russia 12,957,665 WARNING! (Details) 143,974,0592Ukraine 4,295,887 WARNING! (Details) 47,732,0792Presbyopia in the Southwestern Europe (ExtrapolatedStatistics)Azerbaijan 708,154 WARNING! (Details) 7,868,3852Georgia 422,450 WARNING! (Details) 4,693,8922Portugal 947,173 WARNING! (Details) 10,524,1452Spain 3,625,270 WARNING! (Details) 40,280,7802Presbyopia in Southern Europe (ExtrapolatedStatistics)Greece 958,277 WARNING! (Details) 10,647,5292Italy 5,225,172 WARNING! (Details) 58,057,4772Presbyopia in the Southeastern Europe (ExtrapolatedStatistics)Albania 319,032 WARNING! (Details) 3,544,8082Bosnia and Herzegovina 36,684 WARNING! (Details) 407,6082Bulgaria 676,617 WARNING! (Details) 7,517,9732Croatia 404,718 WARNING! (Details) 4,496,8692Macedonia 183,607 WARNING! (Details) 2,040,0852Romania 2,011,999 WARNING! (Details) 22,355,5512Serbia and Montenegro 974,331 WARNING! (Details) 10,825,9002Presbyopia in NorthernAsia (ExtrapolatedStatistics)Mongolia 247,618 WARNING! (Details) 2,751,3142Presbyopia in Central Asia (ExtrapolatedStatistics)Kazakhstan 1,362,933 WARNING! (Details) 15,143,7042Tajikistan 631,040 WARNING! (Details) 7,011,556 2Uzbekistan 2,376,937 WARNING! (Details) 26,410,4162Presbyopia in EasternAsia (ExtrapolatedStatistics)China 116,896,286 WARNING! (Details) 1,298,847,6242 Hong Kongs.a.r. 616,961 WARNING! (Details) 6,855,1252Japan 11,459,970 WARNING! (Details) 127,333,0022 Macau s.a.r. 40,075 WARNING! (Details) 445,2862North Korea 2,042,779 WARNING! (Details) 22,697,5532South Korea 4,341,038 WARNING! (Details) 48,233,7602Taiwan 2,047,485 WARNING! (Details) 22,749,8382Presbyopia in SouthwesternAsia (ExtrapolatedStatistics)Turkey 6,200,452 WARNING! (Details) 68,893,9182Presbyopia in Southern Asia (ExtrapolatedStatistics)Afghanistan 2,566,230 WARNING! (Details) 28,513,6772Bangladesh 12,720,642 WARNING! (Details) 141,340,4762Bhutan 196,701 WARNING! (Details) 2,185,5692India 95,856,354 WARNING! (Details) 1,065,070,6072Pakistan 14,327,670 WARNING! (Details) 159,196,3362Sri Lanka 1,791,464 WARNING! (Details) 19,905,1652Presbyopia in SoutheasternAsia (ExtrapolatedStatistics)East Timor 91,732 WARNING! (Details) 1,019,2522Indonesia 21,460,765 WARNING! (Details) 238,452,9522Laos 546,130 WARNING! (Details) 6,068,1172Malaysia 2,117,023 WARNING! (Details) 23,522,4822Philippines 7,761,752 WARNING! (Details) 86,241,6972Singapore 391,850 WARNING! (Details) 4,353,8932Thailand 5,837,897 WARNING! (Details) 64,865,5232Vietnam 7,439,652 WARNING! (Details) 82,662,8002Presbyopia in the Middle East (ExtrapolatedStatistics)Gaza strip 119,249 WARNING! (Details) 1,324,9912Iran 6,075,288 WARNING! (Details) 67,503,2052Iraq 2,283,722 WARNING! (Details) 25,374,6912Israel 557,910 WARNING! (Details) 6,199,0082Jordan 505,008 WARNING! (Details) 5,611,2022Kuwait 203,179 WARNING! (Details) 2,257,5492Lebanon 339,949 WARNING! (Details) 3,777,2182SaudiArabia 2,321,634 WARNING! (Details) 25,795,9382Syria 1,621,518 WARNING! (Details) 18,016,8742United ArabEmirates 227,152 WARNING! (Details) 2,523,9152 West Bank 208,008 WARNING! (Details) 2,311,2042Yemen 1,802,238 WARNING! (Details) 20,024,8672Presbyopia in NorthernAfrica (ExtrapolatedStatistics)Egypt 6,850,567 WARNING! (Details) 76,117,4212Libya 506,842 WARNING! (Details) 5,631,5852Sudan 3,523,334 WARNING! (Details) 39,148,1622Presbyopia in Western Africa (ExtrapolatedStatistics)Congo Brazzaville 269,823 WARNING! (Details) 2,998,0402Ghana 1,868,132 WARNING! (Details) 20,757,0322Liberia 305,157 WARNING! (Details) 3,390,6352Niger 1,022,448 WARNING! (Details) 11,360,5382Nigeria 1,597,532 WARNING! (Details) 12,5750,3562Senegal 976,693 WARNING! (Details) 10,852,1472Sierraleone 529,550 WARNING! (Details) 5,883,8892Presbyopia in Central Africa (ExtrapolatedStatistics)Central AfricanRepublic 336,823 WARNING! (Details) 3,742,4822Chad 858,468 WARNING! (Details) 9,538,5442Congokinshasa 5,248,532 WARNING! (Details) 58,317,0302Rwanda 741,480 WARNING! (Details) 8,238,6732Presbyopia in EasternAfrica (ExtrapolatedStatistics)Ethiopia 6,420,291 WARNING! (Details) 71,336,5712Kenya 2,968,389 WARNING! (Details) 32,982,1092Somalia 747,414 WARNING! (Details) 8,304,6012Tanzania 3,246,371 WARNING! (Details) 36,070,7992Uganda 2,375,123 WARNING! (Details) 26,390,2582Presbyopia in Southern Africa (ExtrapolatedStatistics)Angola 988,069 WARNING! (Details) 10,978,5522Botswana 147,530 WARNING! (Details) 1,639,2312SouthAfrica 4,000,362 WARNING! (Details) 44,448,4702Swaziland 105,231 WARNING! (Details) 1,169,2412Zambia 992,312 WARNING! (Details) 11,025,6902Zimbabwe 330,467 WARNING! (Details) 1,2671,8602Presbyopia in Oceania (ExtrapolatedStatistics)Australia 1,792,182 WARNING! (Details) 19,913,1442New Zealand 359,443 WARNING! (Details) 3,993,8172Papua New Guinea 487,825 WARNING! (Details) 5,420,2802 • Aboutextrapolations of prevalence and incidencestatistics • Read more at http://www.wrongdiagnosis.com/p/presbyopia/stats-country.htm?ktrack=kcplink • Read more at http://www.wrongdiagnosis.com/p/presbyopia/stats-country.htm?ktrack=kcplink ESCRS 2011

  9. CONCEPTS OF RESTORING ACCOMODATION • MONOVISON:not physiological • LASER TREATMENT OF THE CORNEA?monovion multifocality -the problem is not there • SCERAL EXPANSION PROCEDURES :doubtfulresults • ACCOMODATIVE LENSES -DEFORMABLE ACCOMODATING IOLS Mechanicalconceptsbasedonaxial shift principle have verylimitedaccomodative effect • REFILLING THE EMPTY LENS CAPSULE:WITH SOFTER MATERIAL experimantal stage !!!! See later ESCRS 2011

  10. HOW TO MAKE A BETTER LENS ? • A more basic treatment should be derived from treating the root cause of presbyopia: to make the lens substance softer • A newer technique - currently proposed -consists of mechanically softening the lens substance using femto-second laser pulses • Or one can insert an ersatz lens available now ESCRS 2011

  11. FUTUREEUROTIMES DOUGH KOCH • IN REFRACTIVE AND CATARACT SURGERY PRESBYOPIA CORRECTION WILL BECOME THE NORM • THE HOLY GRAIL OF ACCOMODATIVE LENSES IS BECOMING CLOSER BUT HOW CLOSE? ESCRS 2011

  12. LET US CONCENTRATE ON THE PHACO ERSATZ HOW TO BRING A NEW ARTIFICAL BETTER FUNCTIONING LENS IN AN OLDER EYE ESCRS 2011

  13. THE EYE IN HISTORY IMPORTANT DISCOVERIESHOW FAR ARE WE NOW? HOW SLOW DID IT GO UNTILL NOW !WHAT WILL THE FUTURE BRING? ESCRS 2011

  14. At C DISCOVERY OF LIGHT At that time the popular belief was the emanation hypothesis of vision,advanced by Pythagoras (c. 600 B.C.) and accepted by such classical writers as Euclid, Hipparchos and Ptolemy and after them by Galen. In this hypothesis the visual spirit originating in the brain emanated from the lens (the essential organ of vision) forming a cone of linear IBN al-Haitham (965-1040 wave–particleduality, describedbyAlbert Einstein in the early1900s, ESCRS 2011

  15. DISCOVERY OF SPECTACLESVenice Murano 1270 and 1280. Gutenberg’s invention of the printing press 1450 ESCRS 2011

  16. DISCOVERY OF ANATOMY AND FUNCTION OF THE EYE Georg Bartisch(1535-1606) surgeon and oculist of Dresden published the first systematic work on ocular disease ESCRS 2011

  17. JACQUES DAVIEL FRANCE 1745FIRST REAL CATARACT SURGERY ECCE ESCRS 2011

  18. HAROLD RIDLEYTHE FIRST IOL 1949 Sir Harold Ridley and his wife-medal received at the knighthood ceremony ESCRS 2011

  19. CHARLIE KELMAN receivingpresedentialaward from G.Bush Sr.Modern Era of cataract surgery1967 ESCRS 2011

  20. 1987 JEAN MARIE PAREL PHACO ERSATZ • The Ophthalmic Biophysics Center created in 1970 - Bascom Palmer- director Dr. Edward Norton and Dr. Parel • WHAT HAPPENED SINCE THEN ???? • PERSONAL EXPERIENCE • TRUE VISTA STORZ 3 ZONE DESIGN 1992 • 3M APODIZED PRINCIPLE 1992 ESCRS 2011

  21. FDA PANEL RECOMMENDS APPROVAL OF 3M MULTIFOCAL INTRAOCULAR LENS ST. PAUL, Minn., Jan. 23 /PRNewswire/ -- The Food and Drug Administration's Ophthalmic Advisory Panel today recommended approval with conditions, of the 3M (NYSE: MMM) brand Multifocal intraocular lens (IOL) for sale in the United States. The conditions are related mainly to labeling. The FDA relies on the clinical expertise of the advisory panels to guide its decisions. Generally, approval to market follows advisory panel recommendation. "The advisory panel's recommendation represents an important step forward in making this advanced lens available to ophthalmologists for treatment of cataract patients in the United States," said Robert B. Bomar, manager, 3M Vision Care. "The lens will be commercially available only after final approval by the FDA," Bomar added. Since 1987, the lens has been implanted in approximately 30,000 cataract patients worldwide. Of those, over 700 were involved in the U.S. study, which is currently under review by the FDA. An individual who undergoes cataract surgery and receives a conventional monofocal lens implant typically needs to wear eyeglasses, usually bifocals, following surgery to achieve acceptable near and far vision. The majority of patients implanted with bilateral 3M Multifocal IOLs, however, do not need to wear bifocals; and about half of these patients function entirely without the aid of eyeglasses. The lens has been available for sale to ophthalmologists in most countries for over two years. In March 1991, the 3M Multifocal intraocular lens was the first multifocal lens to receive commercial marketing approval from Japan's Ministry of Health and Welfare. -0- 01/23/92 ESCRS 2011

  22. DID IT WORK ?DID IT LAST? • YES IT WORKED !! • BUT NO SMALL INCISION POSSIBLE SINCE NO Foldable IOL • 6 -6.5 mm. PMMA MATERIAL • NEEDED SUTURING • CREATED ASTIGMATISM • SO IT WAS NOT THE FINAL SOLUTION ESCRS 2011

  23. WHERE DO WE GO?PREDICTION IS VERY DIFFICULT SPECIFICALLY ABOUT THE FUTURE ESCRS 2011

  24. Newersuccesfull models • ALCON RESTOR/old 3M apodized principle 2001 • ABBOTT AMO TECNIS:Ring principle 2003 • Later onadapations; addonnear zone material changes etc.etc.etc.etc. ESCRS 2011

  25. Tecnis One Piece ZMBOO • Fulldiffractive posterior surface • Wavefront-designedaspheric anterior surface • NewestgenerationAcrylic material • Nearaddition +4D=3.1 pupil plane • Onepiece iol :+5.0 D to +34.0 D in 0.5 D increments • Ease of insertion Performance is Pupil Independent ESCRS 2011

  26. New trends EUROTIMES MAY 2011TOO MANY TO BE GOOD • DualopticSynchrony -iol more effect for less movement-2.5 D pro 1 mm. • Opti-Knewform of laser thermal keratoplasty LTK.Adv.itcan be repeated why?becauseregression • Palliklarisgroup:WIOL-CF accomodative iol2D of pseudo-accomodation. ?? ESCRS 2011

  27. INJECTABLE ACCOMODATIVE LENSES-AN INJECTED GEL LENS • IS NOT A NEW CONCEPT !!!! • MATERIAL USED_SILICONE-polyethelene-poloxamer-monomermixture-siliconepolymer gel • 1975-1986-1992-1998-2003 • First publ:1964 Kessler J.Arch.ophtahl. 71,412-417 Experiments in refilling the lens. ESCRS 2011

  28. SOME MAJOR PROBLEMS REMAIN • CREATING A MINICAPSULORHEXIS<2MM: we needinnovativeinstruments and extensivesurgical training • PHACO THROUGH A 1 MM HOLE :innovative approach • SEALING THE MICROCAPSULORHEXIS : to prevent leakage ESCRS 2011

  29. SOME MAJOR PROBLEMS REMAIN • POLYMER BIOCOMPATIBILITY: manymaterials used for iols have passedyears of biocompatibilitytesting. • LENS CAPSULAR VOLUME VARIABILITY:variesamongpatients-the optimum volume should be controlled for eachdifferent eye. • POLYMER REFRACTION:desiredrefraction will be different for eachpatient-controlling the amount of gel is a challenge. • PREVENTING PCO: challenge yag has to be avoidedbecause will createleakage of the injected gel ESCRS 2011

  30. FACTS • PCO PREVENTION WILL REMAIN THE PROBLEM NR 1 • New materialsGuthoff Rostock:pure water-methotrexatemtxantimetabolite-Actinomycin AM = antibioticun-Daunomycin-Disulfiram. • Untill now tested: -Cytostatic drugs:5Fluouracil-Colchicine-Doxoribin-Mitomycin C-Methotrexate-Doxorubicin Anti-inflammatory: Diclofenac-dexamethasone Immunologicalagents:cyclopsorine A FurtherInvestigationsinvolvingnon-primates are needed Cave:Endothelial cells ESCRS 2011

  31. A PARADIGM SHIFT NEEDED?INVENTION OFTrain 1803Bicycle 1839 !!! ESCRS 2011

  32. MULTIFOCAL IOLS WILL BE HERE FOR ANOTHER10 -15 YEARS BUT THEY WILL IMPROVE ! ESCRS 2011

  33. WILL EVENTUALLY THE DREAM OF PHACO ERSATZ COME REALITY ? • PROBABLY YES • BUT WE NEED • MORE TIME ESCRS 2011

  34. ESCRS 2011

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