目 录 第一部分 SBL-3 原理 1 ( 一 ) 概述 1 ( 二 ) 不良视觉效果的产生 2 ( 三 ) SBL-3 主要参数 9 ( 四 ) SBL-3 的植入方位和成像原理 10 ( 五 ) SBL-3 的过渡区 24 ( 六 ) SBL-3 的视觉效果 26 ( 七 ) SBL-3 的中间

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2 目 录 第一部分 SBL-3 原理 1 ( 一 ) 概述 1 ( 二 ) 不良视觉效果的产生 2 ( 三 ) SBL-3 主要参数 9 ( 四 ) SBL-3 的植入方位和成像原理 10 ( 五 ) SBL-3 的过渡区 24 ( 六 ) SBL-3 的视觉效果 26 ( 七 ) SBL-3 的中间视力 30 ( 八 ) 相对其他区域折射产品 31 ( 九 ) 临床注意事项 32 ( 十 ) 总结 34 第二部分相关研究 35 ( 一 ) Initial experience with a new refractive rotationally asymmetric multifocal intraocular lens 35 ( 二 ) Clinical Trial with Dr. Jan Venter OPTICAL EXPRESS UK, London 48 ( 三 ) Multi center study conducted in Czech Republic and Slovakia 50 ( 四 ) Clinical Experience with the SBL-3 Segmented Bi-Focal Lens 54 第三部分会议资料 63 ( 一 ) 西湖国际白内障及人工晶状体高峰论坛 -SBL-3 单元 63 ( 二 ) 屈光白内障手术时代 - 汤欣 64 ( 三 ) 如何从人工晶体设计的角度减少不良视觉效应 - 郝燕生 65 ( 四 ) SBL-3 的手术要点 - 王勇 66 ( 五 ) Clinical Experience with the SBL-3 Segmented Bi-Focal Lens-Danjoux 67 第四部分宣传彩页 68 第五部分公司简介 76

3 SBL-3 是新一代的区域折射设计多焦点人工晶状体 主要的技术特征包括双非球面 零球差 微小过渡区 (7%) 主流区间 0.25D 递进 闭合人工晶体襻 全 360 直角方边 亲水性丙烯酸酯材料等等 但其最突出的优点则在于 : 作为多焦点人工晶体, 相对于传统 同心圆 设计的衍射 / 折射型设计,SBL-3 可以显著性地减少眩光等不良视觉现象的出现 作为目前最新型的区域折射晶体, 借助晶体制造工艺的技术提升, SBL-3 相对于同类产品有很多突破性的改进, 例如 +3D 折射面直达瞳孔区, 最大程度上保证了在瞳孔偏位, 过小的情况下依然有足够的视近功能 除此以外,SBL-3 还有很多其他优点, 下文将进行详细的介绍 1

4 不良视觉现象的产生 : 当视网膜在这个位置 ( 蓝箭头 ) 的 时候, 视近焦点光线重新发散 ( 红 箭头 ), 并在视网膜上形成光晕 当成像物体本身就是 连续 性的发光源时, 根据左上图的光学原理, 则会产生上图中橘色箭头所指的 眩光 根据以上的光学原理我们可以发现, 每增加一个 同心圆 式的成像环, 或者由于设计的多重焦点, 或由于制作工艺问题不能保证所有的成像环都指向预期的焦点, 光晕和眩光显现就会变得更加严重 故而, 这些不良现象是由这种旋转对称 ( 同心圆 ) 的多焦点设计导致的, 是在物理学上不可避免的 但采用区域折射设计的 SBL-3 可以有效地减少其发生 注 : 右上图左侧为福来视系列 Tetraflex 晶体, 其为单焦可调节设计, 故而没有眩光和光晕的发生 2

5 左侧效果图自上而下依次为单焦人工晶体 折射型人工晶体和衍射型人工晶体产生, 验证了我们前文所提的理论 在眩光的严重程度上, 折射型人工晶体 > 衍射型人工晶体 > 单焦人工晶体 根据某一种衍射型多焦人工晶体的研究结果, 约有 20~25% 的比例会产生中 重度眩光等现象, 这远远高于 SBL-3 的研究结果 3

6 此外, 衍射类晶体约有 18~20% 的光学损失, 这些光线并不能在视网膜上成像, 除了本身降低成像效率外, 同时会降低整体的对比敏感度 其效果类似于 暗室中看电影 ( 幻灯 ) 时, 突然有光线射入 的情景 由于衍射型晶体的光学利用率的极限为 82%( 全光学面 ),18% 的能量利用会衍射到高衍射级, 所以从物理理论上推演, 衍射类晶体对比敏感度的丧失无法避免 同心圆式折射型人工晶体如果要解决大量折射环之间的过渡问题, 也需要损失光学能量 而 SBL-3 仅有两个折射面, 故而过渡区仅 7%, 可以有效提高对比敏感度 4

7 SBL-3 的模式图, 下方的为 +3D 折射面, 相当于眼镜平面的 +2.4D, 两 个折射面间的过渡区为 7%, 即为光学损失的总量 5

8 理论上讲, 凡是多焦晶体必定有一定的成像叠加, 实际上本文前述研究中发现单焦人工晶体也有 2~7% 的眩光等现象 上图所示即为单焦晶体产生眩光的原理图 但由于眩光比例较低,SBL-3 和普通单焦人工晶体的患者眩光主诉非常罕见 6

9 事实上, 健康眼也有眩光等现象, 和 SBL-3 及普通的单焦晶体产生原理一致, 通常为我们的视觉心理学原理忽视 上图中当我们注视后方的玩偶时, 一般会忽视前方玩偶耳钉上的眩光, 这个眩光也是由于近处物体不能同时在视网膜上成像导致的 7

10 事实上, 我们在正常视物时, 视觉心理学起到非常重要的作用 由于景深的关系, 左图后方的两个电池并不能在视网膜上清晰成像, 这在我们关注前方电池的时候往往将其直接忽略, 正常人的大脑日常生活中大量采用 背景忽略 策略, 并无不适 当然, 人眼在适当的时候也会采用 小光圈, 大景深 策略来辅助成像, 如右图中, 三个电池都能成像, 虽然光线亮度有一定下降 8

11 以上为 SBL-3 的主要参数, 其光学面直径 5.75, 双非球面, 零球差, 视近区 +3D, 晶体长度 11.0mm, 单片亲水性丙烯酸酯设计, 推荐 IOLmaster 计算晶体度数,SRK-T 公式 A 常数为 ( 若以压陷式 A 超测算,A 常熟为 118.0), 如果使用 Hoffer Q,Holladay 1 或 Holladay 2 公式, 常数应分别是 5.22,1.47 和 5.22 晶体在主流区间以 0.25D 递进, 光损失约为 7~8% 9

12 SBL-3 带给很多人的第一印象是和双光老花镜很类似, 虽然 SBL-3 和双光花镜都有类似的矫正老视眼的功能, 但无论从原理设计还是视觉质量上都有非常大的差别 最主要的差别在于 : SBL-3 位于眼球光学系统的节点, 为同轴多焦设计, 故而可以 360 任意角度放置, 同时不会产生 跳像 双光眼镜位于角膜前方, 为双轴多焦设计, 因此需要复杂的眼球上下移动来适应, 同时会有明显的 跳像 10

13 图中所示为眼成像的模式图, 同样一个 物点 ( 例如图中的树冠 ) 实际上可以通过晶状体的不同部位 ( 本图中缩略为 3 点 ) 分别在视网膜上 同样的位置成像 11

14 在眼球不转动的前提下, 我们节点前搁置遮板, 可以将某一 物点 指向眼球的全部光线同时遮蔽, 故而该物点无法在视网膜上成像 本例中树根的光线被遮挡, 树冠未受影响, 所以视网膜上可见到树的上半部分, 但像的亮度是充足的 12

15 但当把遮光板放入晶体层面 ( 节点层面 ) 的时候, 我们可以看到物点可以利用通过节点的其他光线 ( 本图中缩略为两点 ) 在视网膜上成像 结果我们可以看到, 树冠和树根都能够在视网膜上完整成像, 但由于遮光板阻碍了部分光线, 所以像虽完整, 但亮度有所下降 13

16 除了远处物点外, 近处物点成像原理类似 图中铅笔因晶状体丧失调节力, 无法在网膜上成像 14

17 通过在铅笔前放置凸透镜, 可以帮助铅笔在网膜上成像, 但必须保证 铅笔的经过光线经过凸透镜, 所以对放大镜的位置摆放有严格的要求 同时由于树很少经过该凸透镜, 故而依然在视网膜的原有位置成像 15

18 但当将该镜片置入节点位置 ( 晶体平面 ) 时, 光路图发生明显的变化 树分别利用两个光学面在眼内成像, 其中利用常规度数的光学面所成像位于视网膜, 而利用 +3D 光学面所成像位于网膜前 同理, 铅笔利用常规度数光学面成像在网膜后, 利用 +3D 光学面所成像位于网膜上 所成的四个像均为完整像, 但随着 +3D 比例不同, 亮度的分布也不同 16

19 实际上, 前图所表现的光学线路与 SBL-3(+3D 光学面位于下方 ) 是 完全一致的 17

20 当我们把 +3D 的凸透镜搁置于其他位置的时候, 虽然光学线路有所调 整, 但因为凸透镜的调节力固定, 摆放角度固定, 成像结果无任何改变 18

21 同理, 其与 SBL-3 的 +3D 光学面置于上方的光学线路图是一致的, 而 将 SBL-3 任意角度旋转, 树和铅笔的成像结果也是不变的, 前提是 +3D 光 学面的比例不变,SBL-3 摆放位置正, 与视轴垂直 19

22 总结 SBL-3 的成像原理, 其实基于以下的光学原理 : 当物固定的时候, 无论镜沿原来的摆放平面如何移动, 旋转, 成像位置不变, 成像亮度取决于镜面大小 左图中, 无论镜子上下左右平行移动, 或是面积减少, 蜡烛的成像位置始终不变, 且均完整 右图中镜子向下沿绿色虚线垂直移动, 人所成像也无丝毫改变 即是镜子面积急剧减小, 依然能成完整像, 如小孔成像现象 20

23 但 SBL-3 或许在理论上有相对更富有临床技巧的摆放位置, 当我们考虑到 kappa 角的影响, 或是说视轴与瞳孔 - 黄斑轴不一致的问题时 SBL-3 的折射面之间有细微的过渡区, 如果该过渡区与视轴重合, 理论上视觉效率降至最低, 所以我们建议依据患者 kappa 角的具体情况, 将晶体反光点置于 +3D 扇形的正中央 如下图所示 : 21

24 除此外,SBL-3 摆放的位置也影响着虚影的方向,SBL-3 因为只有两个光学面, 故而不会产生同心圆设计人工晶体导致的眩光和光晕现象, 但多出的光学面会导致向 +3D 对侧面方向发散的虚影, 如上图中所示,+3D 光学面在下方, 则虚影的方向朝向上方 ; 下图中,+3D 光学面位于山方, 则虚影朝向下方 右图中的虚影为极限放大后呈现, 极少有患者会有类似的主诉 22

25 和双光镜相比,SBL-3 为同轴设计, 无需反复调整眼轴 镜片和物体的位置, 所以无适应及疲劳问题 当眼轴在双光眼镜两个光学面移动时产生的 跳像 问题在 SBL-3 也不会出现 23

26 SBL-3 两个光学面间存在细微的过渡区, 约占总体光学面的 7~8%, 也是仅有的光学损失部位 过渡区并不是所谓 +3D~+2D~+1D 的屈光力递进, 过渡区的存在是为了避免光线在两个折射面边缘不可控的折射, 过渡区本身无 过渡 作用, 经过该区域的入射光直接转换为平行或散射光, 不在眼内成像聚焦 24

27 如前所述, 入射于过渡区的光线不成像, 约占总体光学信号的 7~8% 25

28 上图左为普通单焦人工晶体模式图, 植入度数定为正视, 看远 远处楼宇清晰, 近处贝壳细节无法分辨 上图右为普通单焦人工晶体模式图, 植入度数定位近视, 看近 成像效果与左图相反, 近处细节清晰, 远景模糊 26

29 上图左为单纯植入远焦屈光面的效果图, 图右为单纯植入 +3D 屈光面 的效果图, 可以看出图像完整, 对应焦点部位清晰可辨, 但由于分别占 50% 和 42% 的光学量, 故而分别亮度有所降低, 且对比敏感度低 27

30 当 SBL-3 两个光学面全部植入后, 整体亮度损失只有 7~8, 故而光照度和对比敏感度都达到了令人满意的效果 依据视觉心理学的选择规律, 患者可以根据实际需要选择远近不同的清晰画面, 同时抑制不需要的离焦信号 注 : 此为效果图, 事实上当我们注视的时候, 焦点旁相当面积的视觉信号 都被忽视 28

31 衍射和折射型同心圆设计的多焦人工晶状体示意图 ( 假设为 9 个折射面 / 环 ), 可见独立的折射面分别成完整像, 与 SBL-3 类似 当合在一起时, 可见由于衍射环和折射面制造容差导致的眩光及光晕, 同时由于光损失在 18% 以上, 对比敏感度明显下降 29

32 SBL-3 为零球差设计, 故而相当于保留了角膜的正球差, 除了提高晶 体对度数计算不准确 植入偏位 倾斜等耐受力外, 也可以有效地提高景 深, 保证中间视力 30

33 区域折射型晶体最大的并发症是由于瞳孔过小或者偏位, 导致仅有一个光学面发挥作用 作为目前最新设计的区域折射晶体,SBL-3 的视近扇形面直抵圆心的位置, 保证在任意瞳孔大小 ( 左图 ) 远近屈光面的比例都一致, 在相当程度的瞳孔偏位 ( 右图 ) 情况下依然能保证双焦点成像 31

34 SBL-3 的主要植入禁忌包括其他眼病 1D 以上散光及过小的瞳孔 其他可能影响视力的眼病将会导致对 SBL-3 高端晶体的不满意度增加 1D 以上的散光将影响整体晶体效果, 降低患者舒适度和多焦的实用性, 建议结合手术经验 ( 手术切口对散光的影响 ), 选择术后散光值预计在 1D 以下的患者 瞳孔过小或者明显偏位可能导致在晶体位置良好的情况下出现仅有一个光学面发挥作用, 故要谨慎对待, 建议瞳孔大小在 2.75 以上 ( 正常光照度下 ) 32

35 SBL-3 在晶体计算方面没有特殊要求, 但预设屈光度需设定在 +0.05~ 间, 因为 SBL-3 的 +3D 视近功能非常确实, 如果以常规晶体经验保留 0.5D 近视的话, 将会导致视近距离过近, 会给患者带来明显不适 SBL-3 以 0.25D 精确递进, 同时制作容差标准达到国际标准的 3 倍, 能在精确测量的前提下充分保证预期屈光能力 因此 SBL-3 在晶体计算过程实际上要求更高, 考虑到 SRK-Ⅱ 公式的准确性较低,SBL-3 未提供该公式的 A 常数, 也不建议使用该公式 其次建议选择 IOLMASTER,lenstarr 和浸润式 A 超, 而不是压平式 A 超进行测量 33

36 实际上,SBL-3 还有其他众多相关专利, 比如其为双非球面设计, 在各种照明度和瞳孔条件下都能保证最好的对比敏感度, 此外还有包括晶体攀的设计, 晶体直角方边设计以及材质学上的优势, 但 SBL-3 最主要的特征还在于其为矫正老视且最大程度避免眩光等不良视觉效应的人工晶体, 与同类产品相比, 其最新的改进设计保证了最大的安全性和可靠性 34

37 ORIGINAL ARTICLE ELECTRONICALLY REPRINTED FROM NOVEMBER 2014 Initial Experience With a New Refractive Rotationally a New Refractive Asymmetric Rotationally Multifocal Intraocular Asymmetric Lens Multifocal Intraocular Lens Jan A. Venter, MD; Dean Barclay, MD; Martina Pelouskova, MSc; Claire E. E. L. L. Bull, Bull, BSc BSc ABSTRACT PURPOSE: To assess efficacy, safety, predictability, and patient satisfaction after refractive lens exchange with a new refractive rotational asymmetric multifocal intraocular lens. METHODS: One hundred six eyes of 53 patients after bilateral refractive lens exchange with the SBL-3 lens (Lenstec, Inc., Christ Church, Barbados) implantation were evaluated. The mean preoperative refractive sphere was ± 2.63 diopters (D) (range: to D) and the mean refractive cylinder was ± 0.46 D (range: to 0.00 D). Monocular and binocular uncorrected and corrected distance visual acuity, uncorrected and distance-corrected intermediate visual acuity, uncorrected and distance-corrected near visual acuity, defocus curve, and patient satisfaction were evaluated 3 months postoperatively. RESULTS: At 3 months, 84.9% (90 eyes) were within ±0.50 D of emmetropia. The mean postoperative uncorrected distance visual acuity was ± 0.09 logmar (6/6 Snellen) monocularly and ± 0.08 logmar (6/4.8 Snellen) binocularly. The mean monocular and binocular uncorrected near visual acuity were 0.12 ± 0.12 and 0.08 ± 0.10 logmar (6/7.5 Snellen), respectively. Defocus curve showed a slight drop off for vergences equivalent to intermediate vision. Although some night vision phenomena were reported, overall satisfaction was high. No intraoperative or postoperative complications occurred in this study. CONCLUSIONS: The new refractive rotationally asymmetric intraocular lens provided good range of vision for near, intermediate, and distance. Long-term follow-ups are necessary to evaluate the performance of this intraocular lens. [J Refract Surg. 2014;30(11): ] R eplacing the presbyopic or cataractous crystalline lens with an artificial implant to yield the best possible visual outcomes and high patient satisfaction is the aim of modern lens-based surgery. Several multifocal technologies have been developed and evaluated for this purpose, 1,2 and attempts to develop the lens design that can restore vision at all focal distances are ongoing. Refractive rotationally asymmetric intraocular lenses (IOLs), introduced into clinical practice 5 years ago, have already been widely adopted by surgeons around the world. Their development brought a brand new concept to multifocal IOL technology. Instead of traditional concentric rings providing different foci, this lens has two sectors: a larger sector for distance vision, and an inferior surface-embedded sector for near vision with a smooth transition between them. In theory, having fewer transition zones from one power to the next should result in less light dispersion and improved contrast sensitivity. In rotationally asymmetric lenses, there is only one transition zone between the two segments, resulting in only 7% energy loss. Experience with the first commercially available lens of this type (Lentis Mplus; Oculentis GmbH, Berlin, Germany), its advantages, and shortcomings have already been discussed In the current study, we report our initial experience with the second refractive rotationally asymmetric IOL on the market: the SBL-3 lens (Lenstec, Inc., Christ Church, Barbados). To our knowledge, this is the first study of this new lens design. Predictability, visual outcomes, and patient satisfaction were evaluated at 3 months postoperatively. PATIENTS AND METHODS This prospective consecutive case series study enrolled 53 patients who had refractive lens exchange to correct ametropia and presbyopia with bilateral implantation of the SBL-3 IOL. From Eye and Laser institute, Port Elizabeth, South Africa. Submitted: May 12, 2014; Accepted: September 2, 2014; Posted online: November 5, 2014 The authors have no financial or proprietary interest in the materials presented herein. Correspondence: Jan A. Venter, MD, Eye and Laser Institute, 205 Cape Road, Newton Park, Port Elizabeth, South Africa. drjanventer@gmail.com doi: / x

38 New Refractive Rotationally Asymmetric MIOL/Venter et al Inclusion criteria were age of 45 years or older, corrected distance visual acuity (CDVA) of 6/6 or better in each eye, ametropia combined with presbyopia, and corneal astigmatism less than 1.50 diopter (D). Exclusion criteria were a history of glaucoma or retinal detachment, corneal disease, corneal surgery, ocular inflammation, neuro-ophthalmic disease, and macular degeneration or retinopathy. Informed consent was obtained from all patients. The study adhered to the tenets of the Declaration of Helsinki and was approved by the local ethics committee. Patient Assessment All patients had a full preoperative ophthalmologic examination, including refraction, distance and near visual acuities, slit-lamp examination, tonometry, and dilated funduscopy. Additionally, corneal topography (OPD-Scan II; NIDEK Co., Ltd., Gamagori, Japan), endothelial cell count (SP 2000P specular microscope; Topcon Europe BV, Capelle aan den Ijssel, The Netherlands), biometry (IOLMaster; Carl Zeiss Meditec, Jena, Germany), and retinal optical coherence tomography (Cirrus 4000 OCT; Carl Zeiss Meditec) were performed. Postoperatively, patients were evaluated at 1 day, 1 week, and 1, 3, and 6 months. Visual acuities and the refractive status were measured at each follow-up. In addition, 3 months postoperative protocol included the following measurements: manifest refraction, uncorrected distance visual acuity, CDVA, uncorrected and distance-corrected intermediate visual acuity at 70 cm, uncorrected and distance-corrected near visual acuity at 40 cm, defocus curve, and patient satisfaction. Distance visual acuity was evaluated with Snellen charts. Intermediate and near visual acuities were evaluated with the logarithmic near Early Treatment Diabetic Retinopathy Study chart. The defocus curve was obtained monocularly and binocularly with the patient s best distance refractive correction while viewing a distance chart under photopic conditions. The negative lenses were added in 0.50-D steps and the visual acuity was recorded for each type of blur. The same procedure was repeated using positive lenses. Letter sequences were randomized between each level of defocus. Defocus acuities were first corrected for spectacle magnification and monocular and binocular defocus curves were constructed for vergence distances ranging between and D in 0.50-D steps. A patient satisfaction questionnaire was administered at the 3-month follow-up visit. This questionnaire was purpose-developed to evaluate visual symptoms, satisfaction with visual acuity while performing various distance and near tasks, and overall satisfaction with surgery results (Table 1). Patients were asked to rate the incidence of visual phenomena TABLE 1 Patient Satisfaction Questionnaire at 3 Months Postoperatively Question How satisfied are you with the outcome of your procedure? Percent Very Satisfied 75.5% Satisfied 18.9% Neither 5.7% Dissatisfied 0.0% Very dissatisfied 0.0% How much difficulty do you have performing tasks that require good close up vision (such as cooking, fixing things around the house, sewing, using hand tools, and reading or working with a computer?) No difficulty at all 69.8% A little difficulty 17.0% Moderate difficulty 11.3% A lot of difficulty 1.9% Would you recommend this procedure to your family/friends? Yes 98.1% No 1.9% Night vision phenomena (rated on scale from 1 [no difficulty] to 7 [severe difficulty]) Mean ± SD How much difficulty do you have with your vision at night because of starburst around bright lights? How much difficulty do you have with your vision at night because of glare from bright light? How much difficulty do you have with your vision at night because of halo from bright light? 2.8 ± ± ± 1.6 How much difficulty do you have with your vision due to double vision or ghosting around images? 2.5 ± 1.6 SD = standard deviation such as starburst, halo, glare, and ghost images/double vision on a scale between 1 (no difficulty) and 7 (severe difficulty). SBL-3 IOL The SBL-3 (Figure A, available in the online version of this article) is a bi-aspheric asymmetrical refractive multifocal IOL, which has a D addition in the inferior anterior optic. This translates to approximately D at the spectacle plane. It has a small wedgeshaped transition zone separating the (superior) distance from the near power zone. The percentage of optic that is occupied by the near segment is 42%. The IOL length is 11.0 mm, with an optic size of 5.75 mm and it is manufactured from a hydrophilic acrylic material. The multifocal IOL has a neutral aberration profile, 36

39 New Refractive Rotationally Asymmetric MIOL/Venter et al Figure 1. Stability of spherical equivalent for a period of 6 months. D = diopters allowing remnant corneal spherical aberration to impart some additional depth of focus. The diopter range is between and D with 0.50 increments, with the most commonly used mid powers (range: to +25.0) being available in 0.25-D increments. The shape of the haptic is similar to the accommodating lens of the same manufacturer (Tetraflex; Lenstec, Inc.), however, it is three times wider and 1.5 times thicker. Compared to Tetraflex, the SBL-3 lens is not designed for axial movement of the optics to achieve accommodation. Surgical Technique All surgeries were performed by two experienced surgeons (JAV, DB). The pupil was dilated with one pellet of Mydriasert (Spectrum Thea Pharmaceuticals, Cheshire, United Kingdom). The surgery was performed under sub-tenon anesthetic block. After phacoemulsification, the foldable IOL was inserted in the capsular bag through a 2.75-mm corneal incision using the manufacturer s injector (Model LC1620I; Lenstec, Inc.). The IOL was positioned with the near sector opposite to the quadrant where the decentered visual axis was detected related to the pupil. All incisions were placed on the steepest corneal meridian, which was pre-marked with the patient in the upright position to prevent cyclotorsion. The nondominant eye was treated first, followed by the dominant eye 1 week later. Lens calculation was performed using the Holladay II formula. Postoperatively, patients were instructed to instill one drop of levofloxacin 0.5% (Oftaquix; Santen Pharmaceutical, Munich, Germany) four times daily for 2 weeks, one drop of dexamethasone 0.1% (Maxidex, Alcon Laboratories, Fort Worth, TX) four times daily for 2 weeks, and one drop of ketorolac trometamol 0.5% (Acular, Allergan, Irvine, CA) four times daily for 1 month. Statistical Analysis Visual acuity measurements were converted to logmar notation for statistical analysis. Normality of sample size was tested with the Kolmogorov Smirnov test. The Student s paired t test was used to compare preoperative and postoperative data where normality of dataset was assumed; otherwise, the Wilcoxon rank-sum test was applied. Summary statistics, such as means and standard deviations, were presented to describe the study population. All data were analyzed using Microsoft Office Excel 2007 (Microsoft Corp., Redmond, WA) and the STATISTICA (StatSoft, Inc., Tulsa, OK) program. A P value of less than.05 was considered statistically significant. RESULTS One hundred six eyes of 53 patients were included in the study (21 males, 32 females). The mean age of the study cohort was 58.2 ± 6.3 years (range: 48 to 71 years). The mean spherical power of the implanted IOL was ± 3.14 D (range: to D) and the mean preoperative mesopic pupil size was 5.3 ± 0.8 mm (range: 3.0 to 6.7 mm). Twenty eyes were myopic and 86 eyes were hyperopic prior to surgery. Figure 1 displays refractive stability of manifest spherical equivalent for a period of 6 months. Because no statistically significant difference was found between spherical equivalent at 3 and 6 months, all remaining graphs were plotted for 3-month data where thorough examination was performed. The mean preoperative refractive sphere was ± 2.63 D (range: to D) and changed to ± 0.36 D, ranging from to +1.00, (P <.01, Wilcoxon rank-sum test). The mean refractive cylinder reduced from ± 0.46 D (range: to 0.00 D) to ± 0.37 D (range: to 0.00 D). This change 37

40 New Refractive Rotationally Asymmetric MIOL/Venter et al Figure 2. Attempted versus achieved spherical equivalent. The area between the green dashed lines represents spherical equivalent within ±0.50 diopters (D) and the area between the blue dashed lines contains spherical equivalent between ±1.00 D of emmetropia. The red solid line is the linear regression. was statistically significant (P =.03, Wilcoxon ranksum test). Figure 2 plots the predictability of spherical equivalent. Of 106 eyes, 64.2% (68 eyes) were within ±0.25 D, 84.9% (90 eyes) were within ±0.50 D, and 99.1% (105 eyes) were within ±1.00 D of emmetropia. Table 2 summarizes the mean logmar values for postoperative near, intermediate, and distance visual acuity. The percentage of patients achieving uncorrected distance visual acuity of 6/6 (0.0 logmar) or better was 87.7%(93 eyes) monocularly and 94.3%(100 eyes) binocularly. Of 106 eyes, 87.7%(93 eyes) achieved monocular uncorrected near visual acuity and 98.1%(104 eyes) of patients achieved binocular uncorrected near visual acuity of 6/9 (approximately J3) or better. The percentage of patients achieving monocular and binocular uncorrected intermediate visual acuity 6/9 or better was 80.2%(85 eyes) and 90.6%(96 eyes), respectively. Figure 3 displays the cumulative binocular uncorrected distance, intermediate, and near visual acuities. The mean CDVA changed from ± 0.07 logmar (6/4.8 Snellen) preoperatively to ± 0.06 logmar (6/4.8 Snellen) postoperatively, which was not statistically significant (P =.26, paired t test). Safety (change between preoperative and postoperative CDVA) is plotted in Figure 4. Figure 5 shows the mean monocular and binocular defocus curve. Monocular curve shows a peak of D defocus (equivalent to 40 cm viewing distance from the eye) and at 0.0 D (equivalent to distance vision) Parameter TABLE 2 Mean 3-Month Postoperative Visual Acuities Mean ± SD (logmar) (Range) UNVA (40 cm) Monocular 0.12 ± 0.12 (-0.1 ± 0.5) Binocular 0.08 ± 0.10 (-0.1 to 0.3) DCNVA (40 cm) Monocular 0.11 ± 0.10 (-0.1 to 0.3) Binocular 0.08 ± 0.09 (-0.1 to 0.3) UIVA (70 cm) Monocular 0.16 ± 0.11 (0.0 to 0.4) Binocular 0.13 ± 0.10 (-0.1 to 0.4) DCIVA (70 cm) Monocular 0.15 ± 0.10 (-0.06 to 0.4) Binocular 0.10 ± 0.09 (-0.1 to 0.3) UDVA Monocular ± 0.09 (-0.2 to 0.3) Binocular ± 0.08 (-0.2 to 0.18) CDVA Monocular ± 0.06 (-0.2 to 0.08) Binocular ± 0.06 (-0.2 to 0.08) SD = standard deviation; UNVA = uncorrected near visual acuity; DCNVA = distance-corrected near visual acuity; UIVA = uncorrected intermediate visual acuity; DCIVA = distance-corrected intermediate visual acuity; UDVA = uncorrected distance visual acuity; CDVA = corrected distance visual acuity with a slight drop off for intermediate distances (defocus: for 67 cm and -1.0 for 100 cm). This drop off is much less obvious on the binocular defocus curve. Table 1 summarizes the results of the patient satisfaction questionnaire at 3 months postoperatively and mean scores for night vision disturbances. No intraoperative or postoperative complications occurred in this study. DISCUSSION Attempts to combat presbyopia with multifocal IOL implants led to a development of different intraocular lens technologies. These can be divided into a few main categories: refractive, diffractive, and those combining both principles. 1,2 Diffractive lenses are based on the principle of diffraction, whereby light changes direction when it encounters an obstacle (diffractive zones across the lens surface). The light is then directed into different focal points, for near and distant objects. On the other hand, refractive multifocal IOLs have different powers integrated into refractive zones. They can either be traditional, rotationally symmetric with circular refractive zones, or rotationally asymmetric with 38

41 New Refractive Rotationally Asymmetric MIOL/Venter et al Figure 3. Cumulative binocular uncorrected distance, intermediate, and near visual acuity. Figure 4. Safety comparison of preoperative and postoperative corrected distance visual acuity (CDVA). inferior near section. The first commercially available rotationally asymmetric design (Lentis Mplus; Oculentis GmbH, Berlin) has already been extensively evaluated The SBL-3 lens is based on the same principle of two refractive segments (near and distance), but the near segment extends closer to the peripheral optic, whereas the near sector in the Lentis Mplus is significantly regressed from the peripheral optic. Extended near segment could potentially result in fewer night vision optical disturbances and improved near vision. A crucial role in the performance of any multifocal IOL is its predictability of refractive outcome. The new SBL-3 lens is manufactured in quarter diopter increments and ±0.11 D tolerance in the most commonly used dioptric range. Of 106 eyes analyzed in this study, 95 required a lens from this premium range (15.0 to 25.0 D). A recent large population study on predictability of cataract surgery 17 found 40%, 75%, and 95% within ±0.25, ±0.50, and ±1.00 D, respectively, even with the use of optimized A-constants. Our results are superior to this, with 64.2% eyes within ±0.25 D, 84.9% eyes within ±0.50 D, and 99.1% eyes within ±1.00 D of emmetropia. Providing these are our initial cases, refractive predictability could be improved further with the use of optimized A-constant. Refractive stability would, however, need to be evaluated over a long period of time. Studies of the previous design of rotationally asymmetric lenses also highlighted the importance of a haptic design to support the lens in the capsular bag, which provides better stability and predictability and avoids IOL tilt that can negatively affect the performance of this rotationally asymmetric design. 16 This was previously addressed with the use of capsular tension rings and the introduction of a plate haptic design instead of a C-loop. 12,13,15 Although we did not see any cases of refractive shift or IOL tilt in our cohort, long-term follow-up is necessary to assess this. The mean near visual acuity in this study was 0.12 ± 0.12 logmar (6/7.5 Snellen) monocularly and 0.08 ± 0.10 logmar (6/7.5 Snellen) binocularly. Unaided near vision reported with previous design of refractive rotationally asymmetric lens (Lentis Mplus) ranged between 0.08 and 0.30 logmar (6/7.5 and 6/12 Snellen) The mean unaided near visual acuity reported in the literature for diffractive lenses is logmar (6/7.5 Snellen) (95% confidence interval: to 0.098), for refractive lenses logmar (6/9 Snellen) (95% confidence interval: to 0.317), and logmar (6/7.5 Snellen) (95% confidence interval: to 0.082) for the most commonly used hybrid diffractive-refractive lens (ReSTOR; Alcon Laboratories, Inc., Fort Worth, TX). 1 We achieved excellent uncorrected distance visual acuity (-0.03 ± 0.09 logmar [6/6 Snellen] monocularly and ± 0.08 logmar [6/4.8 Snellen] binocularly). This could be attributed to the refractive predictability of the lens, but also to 39

42 New Refractive Rotationally Asymmetric MIOL/Venter et al Figure 5. Mean monocular and binocular defocus curve. Error bars represent standard deviation for each defocus level. D = diopters the fact that the mean preoperative CDVA in this study group was ± 0.07 logmar (6/4.8 Snellen) and a good visual rehabilitation for both distance and near vision was expected. One of the greatest problems multifocal technology endeavors to overcome is the simultaneous achievement of good near and intermediate visual acuity. Generally, lenses with strong near addition have poor performance for intermediation vision, and lowering the near add to help intermediate distances results in poorer near vision Mixing and matching two lens technologies was known as one of the options to overcome this problem. 21,22 Interestingly, previous studies found a good range for intermediate vision with the Lentis Mplus refractive rotationally asymmetric lens. 4,5,8-11,13,15 Authors attribute this to either the gradual transition zone between the two areas of the IOL or some induction of primary coma with this design, providing a larger depth of focus. 4,9,11,15 To address the issue of providing good vision at all distances, a new trifocal technology emerged in recent years (FineVision IOL; PhysIOL, Liege, Belgium). The trifocal design is based on the idea of combining two diffractive profiles, one for distance and near and one for distance and intermediate. 23 Published literature on this design found a good range of intermediate and near visual acuity on defocus curves, with only a slight drop off for intermediate distances. 24,25 Defocus curve with the SBL-3 lens shows a similar profile to those reported with trifocal lenses. However, we achieved higher logmar values for visual acuity at each level of defocus. Whether this is attributable to our sample characteristics (clear lens extraction patients with good preoperative CDVA compared to cataractous patients used in other studies) or to the SBL-3 lens providing clearer visual acuity at all distances compared to the diffractive design needs to be investigated in prospective comparative studies. One of the most important factors resulting in patient dissatisfaction with multifocal technology is the overall reduced quality of vision, loss of contrast sensitivity, and night vision phenomena. The incidence of visual phenomena rated on a scale from 0 to 7 in our study was: starburst 2.8 ± 1.5, glare 3.0 ± 1.6, halos 3.2 ± 1.6, and double vision/ghost images 2.5 ± 1.6. Three months postoperative results are reported and neuroadaptation might still play a role in diminishing these symptoms. Despite some night vision phenomena, overall satisfaction with outcomes was high. In the design of the SBL-3 lens, loss of light in the transition between near and distance sector is negligible, and the lower the loss of energy with an IOL, the better contrast sensitivity and overall clarity of vision is expected. A limitation of our study is the absence of data on contrast sensitivity, which should be evaluated in future prospective studies and compared to a control group using a different IOL. Good visual outcomes were achieved in our initial results of a new refractive rotationally asymmetric lens. The SBL-3 lens provided a good range of functional vision and no major complications were noted over a short follow-up period. A longer follow-up period is necessary to evaluate stability of this lens design. AUTHOR CONTRIBUTIONS Study concept and design (JAV, DB); data collection (MP, CELB); analysis and interpretation of data (JAV, DB, MP); drafting of the manuscript (JAV, MP, CELB); critical revision of the manuscript (JAV, DB); statistical expertise (MP, CELB); administrative, technical, or material support (MP, CELB); supervision (JAV, DB) REFERENCES 1. Cochener B, Lafuma A, Khoshnood B, Courouve L, Berdeaux G. Comparison of outcomes with multifocal intraocular lenses: a meta-analysis. Clin Ophthalmol. 2011;5:

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Effect of diopter and diopter additions in multifocal intraocular lenses on defocus profiles, patient satisfaction, and contrast sensitivity. J Cataract Refract Surg. 2011;37: Alfonso JF, Fernández-Vega L, Puchades C, Montés-Micó R. Intermediate visual function with different multifocal intraocular lens models. J Cataract Refract Surg. 2010;36: Lubiński W, Podboraczyńska-Jodko K, Gronkowska-Serafin J, Karczewicz D. Visual outcomes three and six months after implantation of diffractive and refractive multifocal IOL combinations. Klin Oczna. 2011;113: Yoon SY, Song IS, Kim JY, Kim MJ, Tchah H. Bilateral mixand-match versus unilateral multifocal intraocular lens implantation: long-term comparison. J Cataract Refract Surg. 2013;39: Gatinel D, Pagnoulle C, Houbrechts Y, Gobin L. Design and qualification of a diffractive trifocal optical profile for intraocular lenses. J Cataract Refract Surg. 2011;37: Sheppard AL, Shah S, Bhatt U, Bhogal G, Wolffsohn JS. Visual outcomes and subjective experience after bilateral implantation of a new diffractive trifocal intraocular lens. J Cataract Refract Surg. 2013;39: Alió JL, Montalbán R, Peña-García P, Soria FA, Vega-Estrada A. Visual outcomes of a trifocal aspheric diffractive intraocular lens with microincision cataract surgery. J Refract Surg. 2013;29: Posted with permission from the November 2014 issue of Journal of Refractive Surgery Copyright 2015, Slack Inc. All rights reserved. For more information on use of this content, contact Wright s Media at

44 Journal of Refractive Surgery 新型非旋转对称折射多焦点人工晶体的初始体验 新型非旋转对称折射多焦点人工晶体的初始体验 Jan A. Venter, MD; Dean Barclay, MD; Martina Pelouskova, MSc; Claire E.L. Bull, BSc 目的 : 评估一种新型非旋转对称折射多焦点人工晶体的有效性, 安全性, 可预测性和患者满意度方法 :53 位患者的 106 只眼进行双侧晶体摘除及人工晶体植入术, 植入晶体为 SBL-3(Lenstec, Inc., Christ Church, Barbados), 术后进行相应评估 平均术前屈光范围为 +1.06±2.63D( 幅度 :-8.25 至 +5.00D), 平均屈光柱镜为 -0.51±0.46D( 幅度 :-2.00 至 0.00D) 术后三个月评估单眼和双眼裸眼和矫正远视力, 裸眼和远视矫正中视力, 裸眼和远视矫正近视力, 离焦曲线以及患者满意度 结果 :3 月后,84.9%(90 只眼 ) 在正视眼 ±0.50D 以内 平均术后单眼裸眼远视力为 -0.03±0.09logMAR(6/6 Snellen), 双眼裸眼远视力为 -0.08±0.08logMAR(6/4.8 Snellen) 平均单眼和双眼裸眼近视力分别为 0.12±0.12 和 0.08±0.10logMAR(6/7.5 Snellen) 离焦曲线呈现中视力趋附的轻微下降 虽然有一些夜间不良视觉现象, 但是总体满意度非常高, 在研究中并未发生术中或术后并发症 结论 : 新型非旋转对称折射多焦点人工晶体提供了良好的远 中 近视力范围 有必要对此人工晶体的性能进行长期随访研究 现代人工晶体植入手术的目标是通过植入人工晶体来治疗白内障的同时治疗老视眼, 提供最好的视觉效果和高度的患者满意度 为了这个目的, 人们已研发出多种多焦点人工晶体技术 1,2, 同时尝试研究可提供全程视力的人工晶体 五年前引入临床实践的区域折射旋转非对称人工晶 (IOLs) 已被世界各地医生广泛使用 其为多焦 IOL 技术带来了全新的概念 与传统依靠同心环提供不同焦点有所区别的是, 这款晶体含有两个扇形区域 : 稍大部分扇形区域用于提供远视力, 下方嵌入的扇形区域用于提供近视力, 二者之间含有平稳过渡 理论上, 过渡区越少, 离散光越少, 对比敏感度则越高 在旋转非对称晶体中, 两段之间只有一个过渡区, 所以只有 7% 的能量损失 对市场上可购买的此类晶体的体验 优势和劣势已经有文献进行 探讨 3-16 在本次研究中, 我们报告了对市场上新一代非旋转对称折射多焦点人工晶体 SBL-3 (Lenstec, Inc., Christ Church, Barbados) 的初始体验 据我们所知, 这是该晶体的第一项研究 其预测性 视觉效果和患者满意度均在术后 3 个月进行评估 患者和方法本次连续前瞻性病例研究共入组了 53 位患者, 他们通过晶体摘除及 SBL-3 晶体植入术以矫正屈光异常和老花眼 入组标准为 45 岁以上, 双眼矫正远视力 (CDVA) 均在 6/6 或以上, 屈光异常伴有老花眼, 角膜散光小于 1.50 D 排除标准为青光眼或视网膜脱离 角膜疾病 角膜手术史 眼球炎症 视神经疾病 黄斑变性 或其他视网膜疾病 充分告知并获得全部患者的知情同意 本研究遵守赫尔辛基宣言, 且经地方伦理委员会认可 病人评估所有病人均接受全面术前眼科检查, 包括验光, 远视力和近视力检查, 裂隙灯检查, 眼压测量, 以及散瞳眼底镜检查 此外, 还进行了角膜地形图 (OPD-Scan II; NIDEK Co., Ltd., Gamagori, Japan), 角膜内皮细胞计数 (SP 2000P specular J Refract Surg. 1014;30(11):

45 Journal of Refractive Surgery 新型非旋转对称折射多焦点人工晶体的初始体验 microscope;topcon Europe BV, Capelleaan den Ijssel, The Netherlands), 人工晶体生物测量 (IOLMaster; Carl Zeiss Meditec, Jena,Germany) 和视网膜断层扫描 术后, 分别在 1 天,1 周,1 月,3 月, 和 6 月对病人进行评估 在每次随访中测量视力和屈光状态 此外,3 月术后检查包括以下测量值 : 显然验光, 裸眼远视力, 矫正远视力, 裸眼和远视矫正 70cm 中视力, 裸眼和远视矫正 40cm 近视力, 离焦曲线, 和患者满意度 远视力的检测使用 Snellen 视力表 中视力和近视力检测用 ETDRS 视力表 单眼和双眼离焦曲线是通过病人在明视条件下观看远处表格时的最远屈光矫正获得的 测量时用近视镜片以 0.5D 幅度进行, 每种模糊状态的视力均记录 使用正透镜重复相同步骤 每个离焦等级的字母均为随机排列 首先矫正离焦视力检查眼镜放大率, 单眼和双眼的离焦曲线构建范围在 至 +1.00D 间, 幅度为 0.50-D 在第三个月随访时进行患者满意度问卷调查 此调查问卷的目的是评估视觉症状, 在执行各种远视和近视任务时的满意度以及对手术结果 ( 表 1) 的整体满意度 要求患者排列一些视觉现象的发生率如星芒, 晕轮, 眩光, 和重影 / 双影, 从 1( 没有难度 ) 至 7( 非常困难 ) SBL-3 人工晶体 SBL-3 是一种双非球面非旋转对称折射多焦点人工晶体, 在前方下表面有 +3.00D 的附加度数, 在眼镜平面约 2.5D 它拥有一个微小楔形过渡区, 把 ( 上方 ) 远视度数区和近视度数区分开 近视区所占的光学区百分比为 42% 人工晶体长度为 11.0mm, 光学区大小为 5.75mm, 制作材质为亲水性丙烯酸酯 此多焦点人工晶体为正球差设计, 使得剩余的角膜球差可以保证更大的景深 屈光度范围 +10.0D 至 +36.0D 之间以 0.50 增加, 在最常用的中间度数范围 (+15D 至 +25.0D) 以 0.25D 递增 攀外形与同制造商 (Tetraflex; Lenstec, Inc.) 的可调节晶体相似, 但宽度是其 3 倍, 厚度是其 1.5 倍 与 Tetraflex 相比, 表一 术后三个月患者满意度调查问卷 问题百分比您对手术结果的满意程度? 非常满意 75.5% 满意 18.9% 没感觉 5.7% 不满意 0.0% 非常不满意 0.0% 您在进行需要良好近视力的活动 ( 如烹饪, 维修房屋部件, 缝纫, 使用手工工具, 阅读或使用电脑工作 ) 时, 是否存在困难? 完全没困难 69.8% 有一点困难 17.0% 有些困难 11.3% 非常困难 1.9% 您愿意向您的家人 / 朋友推荐本项手术么? 愿意 98.1% 不愿意 1.9% 夜间不良视觉现象 ( 从 1[ 没有困难 ] 至平均 ±SD 7[ 十分困难 ]) 排序您的夜视力由于强光周围的放射光造成了 2.8±1.5 多大困扰? 您的夜视力由于强光周围的眩光造成了多 3.0±1.6 大困扰? 您的夜视力由于来自强光的晕轮造成了多 3.2±1.6 大困扰? 您的视力由于图像周围的双影或重影造成 2.5±1.6 了多大困扰? SD= 标准偏差 SBL-3 晶体的设计并不是通过晶体的轴向运动而实现调节的 手术技巧所有手术均由两名经验丰富的医生 (JAV, DB) 进行操作 散瞳后在结膜下麻醉封闭状态下进行手术 J Refract Surg. 1014;30(11):

46 Journal of Refractive Surgery 新型非旋转对称折射多焦点人工晶体的初始体验 图 1. 等效球镜 6 个月稳定性 D= 屈光度 白内障超声乳化吸出后, 使用制造商的推注器 (Model LC1620I; Lenstec, Inc.) 把可折叠人工晶体通过 2.75mm 角膜切口植入囊袋 人工晶体放置位置为 +3D 象限远离视轴区, 所有切口均事先标记于患者正上方, 位于角膜顶端最陡峭的区域, 以避免眼球旋转 先治疗非主导眼, 一周后治疗主导眼 晶体计算使用 HolladayⅡ 公式 术后病人分别滴入 0.5% 左氧氟沙星 (Oftaquix; Santen Pharmaceutical, Munich,Germany), 每日四次, 共两周 ;0.1% 地塞米松 (Maxidex, Alcon Laboratories,Fort Worth, TX), 每日四次, 共两周 ; 0.5% 酮咯酸氨丁三醇 (Acular,Allergan, Irvine, CA) 一滴, 每日四次, 共一个月 统计分析视力测量转变为 logmar 标准以进行统计分析 用 Kolmogorov Smirnov 检测样本量的正态分布 正态分布数据用 Student s 配对 T 检验比较术前和术后数据, 其余使用 Wilcoxon 秩和检验 人群性统计量, 如平均值和标准偏差, 均已列出, 以描述研究人群 所有数据的解析都使用 Microsoft Office Excel 2007 (Microsoft Corp.,Redmond, WA) and the STATISTICA (StatSoft, Inc.,Tulsa, OK) 程序 以 P<0.05 作为有统计学意义标准结果研究中包含了 53 位患者的 106 只眼 (21 位男性, 32 位女性 ) 研究组的平均年龄为 58.2±6.3 岁 ( 范围 : 48 至 71 岁 ) 植入人工晶体的平均球面度数为 21.16±3.14D( 范围 :12.00 至 D), 平均术前瞳孔大小为 5.3±0.8mm ( 范围 :3.0 至 6.7 mm) 术前 20 只眼近视,86 只眼远视 图 1 以等效球镜方式展示了 6 个月的屈光稳定性, 因为在 3 到 6 月之间并未发现等效球镜上的显著差异, 所有剩余图形的绘制都是按照 3 月的数据进行的 平均术前屈光幅度为 +1.06±2.63D( 范围 :-8.25 至 +5.00D), 术后变成 +.011±0.36D, 范围为 至 +1.00,( P<0.01,Wilcoxon 秩和测试 ) 平均屈光柱镜从 -0.51±0.46 D ( 范围 : 至 0.00D) 减少到 ±0.37D( 范围 : 至 0.00 D) 这项变化具有统计学显著意义 (P=0.03, Wilcoxon 秩和测试 ) 图 2 描绘出等效球镜值的可预测性 在 106 只眼中,64.2% (68 只眼 ) 度数范围在 ±0.25 D 以内,84.9%(90 只眼 ) 度数范围在 ±0.50 D 以内,99.1% (105 只眼 ) 度数在正视 ±1.00D 以内 表二概括了术后远 中 近视力的平均 logmar 值 单眼裸眼远视力达到 6/6(0.0 logmar) 或以上的百分比为 87.7%(93 只眼 ), 双眼为 94.3%(100 只眼 ) 在 106 只眼中,87.7%(93 只眼 ) 实现了单眼裸眼近视力且 98.1%(104 只眼 ) 的患者实现了双眼裸眼近视力 6/9( 约为 J3) 或以上 患者实现单眼和双眼裸眼中视力 6/9 或以上比率分别了为 80.2%(85 只眼 ) 和 90.6%(96 只眼 ) 图 3 展示 J Refract Surg. 1014;30(11):

47 Journal of Refractive Surgery 新型非旋转对称折射多焦点人工晶体的初始体验 图 2. 预计 VS 结果等效球镜值 绿色虚线间区域代表等效球镜在正视 ±0.50D 之间, 蓝色虚线之间区域代表等效球镜在正视 ±1.00D 之间 红色实线是线性回归趋势 累积双眼裸眼远 中 近视力 平均 CDVA 从术前 -0.06±0.07logMAR(6/4.8 Snellen) 变为术后 ±0.06 logmar(6/4.8 Snellen), 在统计学上并不显著 (P =0.26, 成对 t 测试 ) 安全性( 术前和术后 CDVA 改变 ) 绘制于图 4 中 图 5 展示平均单眼和双眼离焦曲线 单眼曲线在 -2.50D( 相当于眼睛 40cm 视距 ) 和 0.0D( 相当于远视视力 ) 显示出离焦峰值, 在中距视力 (67cm 为 -1.50, 100cm 为 -1.0) 出现轻幅下降 此下降在双眼离焦曲线下降更不明显 表 1 概括术后三个月患者满意度调查问卷结果和夜视力干扰的平均分 研究中未发生术中或术后并发症 讨论通过植入多焦点人工晶体对抗老花眼的尝试带动了多种人工晶体技术的发展 主要分为几大类 : 折射型, 衍射型和折射 / 衍射混合型 1, 2 衍射镜基于衍射原理, 利用光线遇到障碍 ( 透镜表面衍射区 ) 时改变方向 随后光线传播到不同焦点, 用于观看远处和近处物体 另一方面, 折射多焦人工晶体利用不同度数的折射面使光线聚集到折射区, 他们可以是伴有环形折射区的传统旋转对称设计, 也可以是伴有下方扇形区的非旋转对称设计 表 2 平均三个月术后视力 参数 平均 ±SD(logMAR)( 范围 ) UNVA (40 cm) 单眼 0.12 ± 0.12 (-0.1 ± 0.5) 双眼 0.08 ± 0.10 (-0.1 至 0.3) DCNVA (40 cm) 单眼 0.11 ± 0.10 (-0.1 至 0.3) 双眼 0.08 ± 0.09 (-0.1 至 0.3) UIVA (70 cm) 单眼 0.16 ± 0.11 (0.0 至 0.4) 双眼 0.13 ± 0.10 (-0.1 至 0.4) DCIVA (70 cm) 单眼 0.15 ± 0.10 (-0.06 至 0.4) 双眼 0.10 ± 0.09 (-0.1 至 0.3) UDVA 单眼 ± 0.09 (-0.2 至 0.3) 双眼 ± 0.08 (-0.2 至 0.18) CDVA 单眼 ± 0.06 (-0.2 至 0.08) 双眼 ± 0.06 (-0.2 至 0.08) SD= 标准偏差 ;UNVA= 裸眼近视力 ;DCNVA= 远视矫正近视力 ;UIVA= 裸眼中视力 ;DCIVA= 远视矫正中视力 ;UDVA= 裸眼远视力 ;CDVA= 矫正远视力 第一款上市的旋转非对称设计 (Lentis Mplus; Oculentis GmbH, Berlin) 已经受到广泛的评估 3-16 SBL-3 晶体基于同样双折射区 ( 远处和近处 ) 的原理, 但近视区延展的离晶体边缘更近, 而 Lentis Mplus 的近视区明显地从外围向里退 扩大的近视区有助于减少夜视力干扰, 提高近视力 评价多焦点人工晶体表现的一个至关重要的标准就是其屈光结果的可预测性 新型 SBL-3 晶体的制造以 0.25D 递增, 在常用屈光范围内容差为 ±0.11D 在本研究分析的 106 只眼中,95 只眼需要使用此范围内的晶体 [15.0 至 25.0D] 近期一个样本较大的关于白内障手术可 17 预测性的研究发现, 即使使用了最优 A 常数, 也还分别有 40%,75%, 和 95% 的眼睛在 ±0.25,±0.50, 和 ±1.00 D 之间 我们得出的结果优于上一结果, 有 64.2% 的眼睛在 ±0.25D 之间,84.9% 的眼睛在 ±0.50D 之间,99.1% 的眼睛在正视 ±1.00 D J Refract Surg. 1014;30(11):

48 Journal of Refractive Surgery 新型非旋转对称折射多焦点人工晶体的初始体验 图 3. 累积双眼裸眼远 中 近视力 图四. 术前和术后矫正远视力 (SDVA) 安全性对比 之间 以这些作为我们的初始案例, 屈光的可预测性可以通过使用优化 A 常数进一步提高 然而, 屈光的稳定性需要通过长时间的评定 早期旋转非对称晶体设计的研究也强调了囊袋中支撑晶体的襻设计的重要性, 它可以提供更好的稳定性和可预测性, 并且避免晶体倾斜, 而晶体倾斜会非常影响这种旋转非对称设计 16 的表现 这种设计曾用于囊袋张力环和取代 C 攀 12,13,15 的板状襻设计的引入 尽管在我们的样本群中未见到任何屈光改变或人工晶体倾斜, 要评估这一点还需要长期随访 研究中, 单眼平均近视力为 0.12 ± 0.12logMAR(6/7.5 Snellen), 双眼为 0.08 ± 0.10 logmar (6/7.5 Snellen) 先前的屈光旋转非对称晶体 (Lentis Mplus) 设计报告中的裸眼近视力范围为 0.08 至 0.30 logmar (6/7.5 和 6/12Snellen) 3-13 文献报告中衍射型人工晶体平均裸眼近视力为 logmar(6/7.5 Snellen) (95% 置信区间 :0.067 至 0.098), 折射型人工晶体为 logm AR (6/9 Snellen)(95% 置信区间 :0.118 至 0.317), 最常用的组合折射 - 衍射透镜 (ReSTOR;Alcon Laboratories, Inc., Fort Worth, TX) 1 为 logmar (6/7.5 Snellen) (95% 置信区间 :0.046 至 0.082) 我们实现了卓越的单眼裸眼远视力 (-0.03±0.09 logmar[6/6 Snellen] 和双眼 ± 0.08 logmar[6/4.8 Snellen] binocularly) 这可以归功于晶体屈光可预测性, 也可归功于研究中平均术前 CDVA 为 ± 0.07 logmar (6/4.8 Snellen) 的事实及远视力和近视力的良好康复 多焦点技术努力克服的最大问题之一就是良好近视力和中视力的同时形成 一般来说, 含有强度近视力附加的晶体, 中视力效果不好, 而降低近视力的附加以获得良好中视力会导致近视力效果变差 混合和匹配两种晶体的技术是已知的可克服此类问题的一种选择 有趣的是, 先前的研究使用 Lentis Mplus 屈光旋转非对称晶体发现了大范围的中视力 4,5,8,-11,13,15 笔者认为这一点或许是因为人工晶体两区之间的过渡区或这种设计的像差效应提供了更大的焦深 4,9,11,15 为了解决提供全距离良好视力的问题, 新型三焦点技术在近几年应运而生 (FineVision IOL; PhysIOL, Liege, Belgium) 三焦点设计基于结合两种衍射剖面的理念, 一个用于远视和 J Refract Surg. 1014;30(11):

49 临床病例报告 [ 文档标题 ] 图 5. 平均单眼和双眼离焦曲线 误差线代表每个离焦等级的标准偏差 D= 屈光度 近视, 一个用于远视和中视 23 有关此设计的发表文献在离焦曲线发现了大范围的中视力和近视力, 同时中视力只有小幅度滑落 SBL-3 晶体的离焦曲线表现出与报告的三焦点晶体相似的剖面 然而, 我们实现了各焦点更高的视力 这可能归因于我们的样本选择 ( 与其他实验的白内障患者相比, 晶体更彻底地吸出, 患者术前拥有良好 CDVA), 或是因为与衍射设计相比,SBL-3 晶体提供各距离更清晰的视力, 这需要在未来的比较研究中进行调查 导致病人对多焦点技术不满意最重要的原因之一是整体下降的视觉质量, 对比敏感度的缺失以及不良夜间视觉现象 在我们的研究中, 从 0 至 7 视力现象发病率为 : 星芒 2.8±1.5, 眩光 3.0±1.6, 晕轮,3.2±1.6, 双影 / 重影 2.5±1.6 通过三个月术后结果报告发现减少这些现象主要依靠神经适应 除了一些夜视现象, 结果整体满意度很高 在 SBL- 3 晶体设计中, 近视区和远视区间过渡区的光损失可忽略不计, 而人工晶体能量损失越低, 对比敏感度越高, 也有望获得整体的清晰度 我们研究的局限性是缺少对比敏感度的数据, 应该在进一步的前瞻性研究中进行评估和和与对照组对比 我们的新型屈光旋转非对称晶体的初始结果达到良好的视觉效果 SBL-3 晶体可提供大范围的功能性视力, 在短期随访内也未发现明显并发症 评估此晶体设计的稳定性还需要长期的随访 Optometry and Vision Science, Vol. 92, No. 1, January 2015 Copyright American Academy of Optometry. Unauthorized reproduction of this article is prohibited. 47

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65 西湖国际白内障及人工晶状体高峰论坛 SBL-3 单元 63

66 屈光白内障手术时代 - 汤欣 64

67 如何从人工晶体设计的角度减少不良视觉效应 - 郝燕生 65

68 SBL-3 的手术要点 - 王勇 66

69 Clinical Experience with the SBL-3 Segmented Bi-Focal Lens-Danjoux 67

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78 深圳市新产业眼科新技术有限公司 (Shenzhen New Industries Material of Ophthalmology Co., Ltd) 和北京明达同泽科技有限公司 ( Beijing Mingda Technology Co., Ltd) 是 NIMO 集团的重要眼科医疗技术公司, 是中国大陆眼科设备和耗材的主要销售商之一 NIMO 集团管理总部位 于中国北京, 研发总部分设在美国纽约和加拿 大渥太华 办公楼 NIMO 先后与美国 Lenstec 公司 美国 OASIS 公司 瑞士 Aptissen 公司和加拿大 Annidis 公司建立了合作关系, 产品覆盖产品覆盖白内障 青光眼 眼表疾病和眼底领域 NIMO 是眼科领域的培训专家 根据不同的技术需求, 对医生 员工和售后服务人员设计了不同的培训方式和内容, 提高了专业实 力 培训 售后服务网络 NIMO 是眼科行业的重要领导者, 现已在北京 深圳分别建立了管理和后勤总部, 在沈阳 北京 上海 武汉 长沙 成都 重庆 深圳 西安 哈尔滨 杭州 昆明 郑州 13 个城市设立了区域营销中心及销售部, 有力的保证了该区域优质 及时的服务 76

79 Overview Lens Production and Manufacturing Dedication to Quality 77

80 Sales and Inventory Manufacturing 78