tecnis toric人工晶体讲者幻灯

基于屈光协力精确矫正散光

—TECNIS®Toric非球面人工晶体

STARTTECNIS

Toric非球面人工晶体2011.05.05-CT3391TECNISToric人工晶体是一款波前设计的Toric非球面晶体，基于TECNIS一片式高端晶体平台，提供不需要依赖眼镜的、更敏锐的远视力。基于TECNIS一片式高端平台和屈光协力人工晶体的某一个特点可以提供一个单独的益处多种特点联合起来共同作用产生的屈光协力而获得的益处将会使视觉质量获得更大的提升

屈光协力更敏锐的视力限制LEC移行无闪辉透过健康的蓝光减少色差零球面像差2011.05.05-CT3391TECNIS系列人工晶体优势ZhaoH,etal.PresentedatESCRS,2009.2.ZhaoH.MainsterM.JCRS.2007.3.Mainster.BJO.2006.4.GunencU.JCRS.2001.5.NixonDR.PresentedatESCRS,2007.2011.05.05-CT3391特性利益全眼零球面像差相比全眼球差残留0.1um的晶体，对比敏感度可提高13%1减少色差最高的阿贝数55，比阿贝数为37的其他疏水丙烯酸材质提供对比敏感度12%1,2不阻断蓝光更佳的生物节律；比黄晶体，提高暗视觉敏感度达21%3无闪辉在高空间频率，相比有闪辉的材质，提供40%的对比敏感度4ProTec

360°边缘设计

Tri-Fix

3点设计居中性和旋转稳定性优秀；阻止LEC移行，低PCOTECNIS

Toric人工晶体：屈光协力+Toric屈光协力更敏锐的视力限制LEC移行无闪辉透过健康的蓝光减少色差零球面像差汇集Tecnis系列人工晶体的优势和先进技术于一身，精确矫正散光2011.05.05-CT3391两者区别：TECNIS

Toric人工晶体与Tecnis一片式IOL2011.05.05-CT3391TECNIS®ZCB00IOL非球面前表面球镜度数范围+5.0-+34.0D，以0.5D递增TECNIS®TORICIOL非球面、复曲面前表面屈光度范围SE球镜度数:+5.0–+34.0D，以0.5D递增散光度数:1.0,1.5,2.25,3.0,4.0D可供选择的散光型号及矫正范围出色的旋转稳定性：确保矫正散光的长期效果Tri-Fix三点固定技术独特的三点固定技术设计，提供优秀的旋转稳定性，确保长期的散光矫正效果ProTEC™360°边缘设计与后囊不间断的接触，即使在光学部-襻的链接处

360°方形边缘设计可限制LEC细胞的移行

Tri-Fix三点固定技术2011.05.05-CT3391TECNIS

Toric人工晶体：设计四个标记使得大瞳孔患者的晶状体植入更精准抛光处理过的边缘可以减少眩光各种屈光度的中央厚度一致，可以保证2.2-2.4切口大小圆滑的襻使得晶体在囊袋内的伸展可控、平缓2011.05.05-CT3391TECNIS

Toric人工晶体：技术参数疏水丙烯酸酯材料（UV阻断）折射率：1.47（35°C）双凸面镜片光学部直径6.0mm全长13.0mm前表面Toric设计和非球面设计前表面的柱镜轴向标记，表示人工晶体屈光度最低的子午线2011.05.05-CT3391TECNIS

Toric

IOL：FDAIDE临床研究1.DataonFile140-TECNISToricRotationalStabilityData2011.05.05-CT3391前瞻性多中心研究(美国和加拿大14家医院参加)前瞻性、多中心、双盲、双眼植入、术后6个月追踪主要研究内容:旋转稳定性裸眼远视力最佳矫正远视力显性验光TECNISToric

IOL：FDA

IDE

Study旋转稳定性1超越ANSI标准的旋转稳定性，术后3个月连续随访，超过90%的轴向旋转≤5.0°(N=148)1.DataonFile140-TECNISToricRotationalStabilityData2011.05.05-CT3391TECNISToric

IOL：FDA

IDE

Study旋转稳定性1术后6个月旋转度，平均为2.74°，94%≤5.0°1.DataonFile140-TECNISToricRotationalStabilityData2011.05.05-CT3391TECNISToric临床研究结果：散光矫正欧洲4家医院多中心研究结果显示1术后散光显著降低，从-1.91±1.07D降低到0.67±0.54D平均的晶体轴位偏离仅3.4度1.AmyL.Sheppard,JCataractRefractSurg2013;39:41–47;2011.05.05-CT3391TECNISToric临床研究结果：裸眼远视力欧洲4家医院多中心研究结果显示1术后平均裸眼远视力（UDVA）为0.15logMAR±0.17(SD)1；UDVA达到20/40及以上为88%；达到20/32及以上为72%患者术后满意度高，93.1%认为非常满意或满意，没有患者选择不满意1.AmyL.Sheppard,JCataractRefractSurg2013;39:41–47;2011.05.05-CT3391TECNIS

Toric

IOL植入系统2011.05.05-CT3391OneSeriesUltra植入系统UNFOLDER白金1系列植入系统One-SeriesUltra植入系统:简单易用的推注式植入UNFOLDER白金1系列植入系统：实现微切口植入2.2-2.4mm通过TECNISToric度数计算器获得高精度结果TECNISToric专有在线计算器,可提供简单直观的用户界面，可提供中文版本快速且准确计算Toric计算器所需数据陡峭轴K值陡峭周子午线轴向平坦轴K轴平坦轴子午线轴向术源性散光预估值切口位置

2011.05.05-CT3391TECNISToric度数计算器：空白页2011.05.05-CT3391TECNISToric度数计算器：空白页2011.05.05-CT3391TECNIS

Toric

IOL：快速启动指南2011.05.05-CT3391患者选择标准术前规则散光可连续环形撕囊稳定、完整的囊袋没有可影响囊袋居中性和稳定性的眼内疾病或其他风险因素术前注意事项术前、术后使用统一的角膜曲率测量方法使用角膜地形图甄别角膜的不规则散光使用TECNISToric计算器确定准确的Toric晶体型号和度数将散光计算结果打印并带入手术室在术巾覆盖之前，在术眼角膜缘的两个位置（相距180度，如3点和9点位置）做出标记，确保患者垂直坐位和术中的散光轴向一致TECNIS

Toric

IOL：快速启动指南2011.05.05-CT3391术中注意事项使用Toric计算器的结算结果核实TECNIS®Toric晶体的型号、度数和散光轴向使用轴向标记尺和标记笔确定角膜最陡峭轴向晶体植入后，确保晶体前表面的四个标记点与最陡峭轴向标记一致，以达到最佳散光矫正效果轴向定位步骤基本一致：晶体植入囊袋后，顺时针旋转晶体,距计算位置约10-15度停止；清除粘弹剂：使用惯常的技术清除粘弹剂，并确保晶体没有旋转越过计算位置；最终定位：使用常规的手术技术顺时针旋转晶体，直到晶体精确地定位到预定的计算位置。TECNIS

Toric

IOL：快速启动指南2011.05.05-CT3391避免术后旋转的建议需要小心移除晶状体后方的OVD首先水合切口，再移走OVD最后定位时，轻柔地向后囊方向推挤人工晶体使用粘滞度强的OVD(非弥散)不要过度挤压眼球如果需要重新旋转人工晶体，必须在术后4周内完成TECNISToric:小结基于TENIS高端晶体平台设计精确矫正散光，提供不依赖眼镜的远视力优秀的旋转稳定性，确保长期矫正效果2011.05.05-CT3391IndicationsImportantSafetyInformation–TECNIS®Toric1-PieceIOLCAUTION:Donotusethelensifthepackagehasbeendamaged.Thesterilityofthelensmayhavebeencompromised.DEVICEDESCRIPTION:TheTECNIS®Toric1-piecelensisanultraviolet-lightabsorbingposteriorchamberintraocularlens(IOL)whichcompensatesforcornealsphericalaberrationsandcornealastigmatism.Itisdesignedtobepositionedinthelenscapsulewherethelensshouldreplacetheopticalfunctionofthenaturalcrystallinelens.TheTECNIS®Toric1-pieceIOLincorporatesaproprietarywavefront-designedtoricasphericopticwithasquaredposterioropticedgedesignedtoprovidea360degreebarrier.Theedgeoftheoptichasafrosteddesigntoreducepotentialedgeglareeffects.Theanteriorlylocatedcylinderaxismarksdenotethemeridianwiththelowestpower.INDICATIONSFORUSE:TheTECNIS®Toric1-piecelensisindicatedforthevisualcorrectionofaphakiaandpre-existingcornealastigmatisminadultpatientswithorwithoutpresbyopia,inwhomacataractouslenshasbeenremovedbyextracapsularcataractextractionandwhodesireimproveduncorrecteddistancevision,reductionofresidualrefractivecylinderandincreasedspectacleindependencefordistancevision.Thisdeviceisintendedtobeplacedinthecapsularbag.PRECAUTIONS:1.Donotresterilizethelens.Moststerilizersarenotequippedtosterilizethesoftacrylicmaterialwithoutproducingundesirablesideeffects.2.Donotsoakorrinsetheintraocularlenswithanysolutionotherthansterilebalancedsaltsolutionorsterilenormalsaline.3.Donotstorethelensindirectsunlightoratatemperaturegreaterthan113°F(45°C).Donotautoclavetheintraocularlens.4.PleaserefertothespecificinstructionsforuseprovidedwiththeinsertioninstrumentorsystemfortheamountoftimetheIOLcanremainfoldedbeforetheIOLmustbediscarded.5.Whentheinsertionsystemisusedimproperly,thehapticsoftheTECNIS®Toric1-piecelensmayebroken.Pleaserefertothespecificinstructionsforuseprovidedwiththeinsertioninstrumentorsystem.WARNINGS:Physiciansconsideringlensimplantationunderanyofthefollowingcircumstancesshouldweighthepotentialrisk/benefitratio:1.Patientswithrecurrentsevereanteriororposteriorsegmentinflammationoruveitis.2.Patientsinwhomtheintraocularlensmayaffecttheabilitytoobserve,diagnoseortreatposteriorsegmentdiseases.3.Surgicaldifficultiesatthetimeofcataractextraction,whichmayincreasethepotentialforcomplications(e.g.,persistentbleeding,significantirisdamage,uncontrolledpositivepressureorsignificantvitreousprolapseorloss).IndicationsImportantSafetyInformation–TECNIS®Toric1-PieceIOLcontinued:WARNINGSContinued:4.AcompromisedeyeduetoprevioustraumaordevelopmentaldefectsinwhichappropriatesupportoftheIOLisnotpossible.5.Circumstancesthatwouldresultindamagetotheendotheliumduringimplantation.6.Suspectedmicrobialinfection.7.PatientsinwhomneithertheposteriorcapsulenorthezonulesareintactenoughtoprovidesupportfortheIOL.8.Childrenundertheageof2yearsarenotsuitablecandidatesforintraocularlenses.9.TheTECNIS®Toric1-pieceIOLshouldbeplacedentirelyinthecapsularbagandshouldnotbeplacedintheciliarysulcus.10.RotationofTECNIS®Toric1-pieceIOLsawayfromtheirintendedaxiscanreducetheirastigmaticcorrection.Misalignmentgreaterthan30°mayincreasepostoperativerefractivecylinder.Ifnecessary,lensrepositioningshouldoccurasearlyaspossiblepriortolensencapsulation.11.Carefullyremoveallviscoelasticfromthecapsularbag.Residualviscoelasticmayallowthelenstorotate,causingmisalignmentoftheTECNIS®Toric1-pieceIOLwiththeintendedaxisofplacement.ADVERSEEVENTS:PotentialadverseeventsduringorfollowingsurgeryoftheTECNIS®Toric1-piecelensmayincludebutarenotlimitedto:•Endophthalmitis•Hypopyon•Pupillaryblock•Retinaldetachment•Acutecornealpensation•Secondarysurgicalintervention(includingimplantrepositioning,removal,ACtaporothersurgicalprocedure).ATTENTION:ReferencetheDirectionsforUseforacompletelistingofindications,warnings,andprecautions.IndicationsImportantSafetyInformation–TheUNFOLDERPlatinum1SeriesImplantationSystemCaution: Federallawrestrictsthisdevicetosalebyorontheorderofaphysician.Indications: TheUNFOLDERPlatinum1SeriesimplantationsystemisusedtofoldandassistininsertingTECNIS®1-Pieceintraocularlenses(IOL),ONLYintothecapsularbag.Warnings: TheUNFOLDERPlatinum1SeriesImplantationSystemshouldonlybeusedwithTECNIS®1-PieceIOLs.Donotuseifthecartridgetipiscrackedorsplitpriortoimplantation.Neverreleasetheplungeruntiltheopticbodyhasbeencompletelyreleasedfromthecartridgetube.Thelensandcartridgeshouldbediscardedifthelenshasbeenfoldedwithinthecartridgeformorethan5minutes.IftheIOLisnotproperlyplacedinthecartridge,theIOLmaybedamagedand/orimplantedupsidedown.TheModel1MTEC30cartridgeisintendedforsingleuseonly.AMOsingle-usemedicaldevicesarelabeledwithinstructionsforuseandhandlingtominimizeexposuretoconditionswhichmaycompromisetheproduct,patient,ortheuser.Donotattempttomodifyoralterthisdeviceoranyofthecomponents,asthiscansignificantlyaffectthefunctionand/orstructuralintegrityofthedesign.Useofmethylcelluloseviscoelasticsisnotmendedastheyhavenotbeenvalidatedwiththisimplantationsystem.Donotimplantlensifrodtipesjammedinthecartridge.Precautions: TheuseofviscoelasticsisrequiredwhenloadingtheIOLintothecartridge.ForoptimalperformanceusetheAMOHealon®familyofviscoelastics.Donotusebalancedsaltsolution.ThecombinationoflowoperatingroomtemperaturesandhighIOLdiopterpowersmayrequireaslowerdelivery.Donotuseifanycomponentofthisimplantationsystemhasbeendroppedorinadvertentlystruckwhileoutsideoftheshippingcase.Donotstorethecartridgesattemperaturesunder5°Corover30°C.Contraindications:Donotusethehandpieceiftherodtipappearsnickedordamagedinanyway.TECNISToric:小结ImportantSafetyInformation–DK7786HandpiecewiththeOneSeriesUltraCartridgeImplantationSystemIndications:TheDK7786handpieceisusedincombinationwiththeOneSeriesUltracartridgeimplantationsystemisusedtofoldandassistininsertingTECNIS®1-Pieceintraocularlenses(IOL),ONLYintothecapsularbag.Warnings:TheDK7786handpiecewiththeOneSeriesUltracartridgeimplantationsystemshouldonlybeusedwithTECNIS®1-PieceIOLs.Donotuseifthecartridgetipiscrackedorsplitpriortoimplantation.Neverreleasetheplungeruntiltheopticbodyhasbeencompletelyreleasedfromthecartridgetube.Thelensandcartridgeshouldbediscardedifthelenshasbeenfoldedwithinthecartridgeformorethan5minutes.IftheIOLisnotproperlyplacedinthecartridge,theIOLmaybe