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爱尔康Clareon Vivity IOL在欧洲获得CE标志认证并在欧洲实现商业化,拓展视觉可能性

Alcon Announces CE Mark Approval and Commercialization of Clareon Vivity IOL in Europe, Expanding Visual Possibilities

爱尔康 等信源发布 2025-03-25 13:04

可切换为仅中文


Alcon (SIX/NYSE: ALC), the global leader in eye care dedicated to helping people see brilliantly, today announced that Vivity

爱尔康(SIX/NYSE:ALC),全球眼保健领域的领导者,致力于帮助人们获得清晰视力,今天宣布Vivity

extended depth of focus (EDOF) intraocular lens (IOL), is now available on Alcon’s most advanced lens material—Clareon

延伸焦深(EDOF)人工晶状体(IOL),现已应用于爱尔康最先进的镜片材料——Clareon。

Clareon Vivity

克拉里昂·维维蒂

received CE Mark and will commence commercial rollout in Europe from early Q2 2025.

获得了CE标志,并将于2025年第二季度初开始在欧洲进行商业推广。

'Cataracts are the most common cause of vision loss globally

白内障是全球视力丧失的最常见原因

, and in Germany alone, 10 million patients are affected by cataracts.

,仅在德国,就有1000万患者受到白内障的影响。

Due to advancements in cataract surgery and increased awareness of its safety and benefits, my practice has seen a growing number of middle-aged patients seeking early treatment,' said Prof. Dr. Ramin Khoramnia, Director of the University Eye Clinic in Dresden.

德累斯顿大学眼科诊所主任拉明·科拉姆尼亚教授表示:“由于白内障手术的进步以及对其安全性和益处的认识增加,我们诊所看到越来越多的中年患者寻求早期治疗。”

'Many of these patients are still working, very active, and want high-quality vision for both distance and intermediate tasks. With Clareon Vivity, I can provide my patients a presbyopia-correcting IOL, significantly reducing their need for glasses..

“这些患者中的许多人仍在工作,非常活跃,并且希望在远距离和中距离任务中都拥有高质量的视力。通过Clareon Vivity,我可以为患者提供一种老花眼矫正型人工晶体,大大减少他们对眼镜的依赖。”

Vivity’s compelling real-world outcomes demonstrate that patients with certain mild comorbidities—such as age-related macular degeneration (AMD), retinopathy/maculopathy, glaucoma, and dry eye—as well as those with post-refractive eyes, can successfully receive presbyopia-correcting IOLs. The study further reported high patient satisfaction rates of over 90% across these diverse eye condition groups..

Vivity令人信服的实际结果表明,患有某些轻度合并症的患者——如年龄相关性黄斑变性(AMD)、视网膜病变/黄斑病变、青光眼和干眼症——以及那些接受过屈光手术的患者,可以成功接受老花眼矫正型人工晶状体(IOL)。研究还报告称,在这些不同眼部状况的患者群体中,满意度高达90%以上。

'Clareon Vivity will broaden my presbyopia correction offering to more patients, including those with ocular comorbidities like glaucoma, age-related macular degeneration (AMD), or dry eyes.

“Clareon Vivity 将为更多患者提供老花眼矫正方案,包括那些患有青光眼、年龄相关性黄斑变性 (AMD) 或干眼症等眼部并发症的患者。

Clareon Vivity’s broad range of dioptres and cylinders will help me address mild, moderate and high refractive error patients with a PCIOL,

Clareon Vivity的广泛度数和柱镜范围将帮助我通过PCIOL解决轻度、中度和高度屈光不正患者的问题,

” said Dr. Mercè Guarro, CEO Instituto de Oftalmologia Médica y Quirúrgica OMIQ & Head of Ophthalmology Department at Hospital Granollers. “Clareon Vivity is an excellent lens option that improves vision with a visual disturbance profile of a monofocal IOL, giving my patients the freedom to engage in activities they love, both during the day and at night.”.

“OMEQ眼科医学与外科研究所首席执行官、格拉诺勒斯医院眼科主任梅西·瓜罗博士说道:“Clareon Vivity是一款出色的镜片选择,它改善了视力,同时具备单焦点人工晶体的视觉干扰特性,使我的患者能够自由地参与他们热爱的活动,无论白天还是夜晚。””

Clareon is a pristine material with one of the lowest levels of haze and glistenings

Clareon是一种 haze 和 glistenings 水平最低的纯净材料之一。

compared to leading competitor IOLs, marking a significant advancement for surgeons and patients.

与领先的竞争对手人工晶状体相比,标志着外科医生和患者的重大进步。

Clareon offers sharp, crisp vision with a proprietary edge designed to help reduce glare and posterior capsular opacification.

Clareon提供清晰、锐利的视觉效果,其专有的边缘设计有助于减少眩光和后囊膜混浊。

The lens’ unique and proven STABLEFORCE

镜头独特的且经过验证的STABLEFORCE

Haptics provide excellent axial and rotational stability.

触觉提供出色的轴向和旋转稳定性。

“When we created Vivity, our goal was to develop an innovative lens that would minimize patients' reliance on glasses and simplify presbyopia correction for surgeons. We achieved this by designing a real EDOF lens, which has quickly become the world’s most implanted EDOF. This lens is now available in our most advanced biomaterial to date, Clareon,.

“当我们创建Vivity时,我们的目标是开发一种创新的镜片,以减少患者对眼镜的依赖,并简化外科医生对老花眼的矫正。我们通过设计一款真正的EDOF镜片实现了这一目标,这款镜片迅速成为全球植入最多的EDOF镜片。如今,这款镜片已采用我们迄今为止最先进的生物材料Clareon问世。

” said Sunil Vasanth, Vice President Surgical Franchise, Europe.

”欧洲外科特许经营副总裁苏尼尔·瓦桑特说。

Clareon Vivity leverages a wavefront-shaping optical principle, trademarked as X-WAVE™ Technology, and uses proprietary transition elements to create advanced and delayed wavefronts, resulting in a continuously extended focal range.

Clareon Vivity 利用一种波前整形光学原理(商标为 X-WAVE™ 技术),并使用专有的过渡元素来创建先进且延迟的波前,从而实现连续扩展的焦距范围。

When compared to an aspheric monofocal, Clareon Vivity reduced spectacle dependence, provided comparable distance vision, and improved intermediate and near vision while maintaining overall mesopic contrast sensitivity. About 90% of the Vivity patients are highly satisfied with their visual outcomes and would choose a Vivity IOL again, and more than 9 in 10 patients said they would recommend Vivity to their friends and family..

与非球面单焦点相比,Clareon Vivity减少了对眼镜的依赖,提供了相当的远视力,并改善了中程和近程视力,同时保持了整体的中光对比敏感度。大约90%的Vivity患者对其视觉效果非常满意,并表示会再次选择Vivity人工晶体,超过90%的患者表示会向朋友和家人推荐Vivity。

Now with the CE Mark of Clareon Vivity and Clareon Vivity Toric, surgeons in Europe have access to the full range of Clareon IOLs to meet the diverse needs of their patients, including Clareon Monofocal, Clareon Toric, Clareon PanOptix

现在,随着Clareon Vivity和Clareon Vivity Toric获得CE认证,欧洲的外科医生可以使用全系列的Clareon人工晶状体,以满足患者的多样化需求,包括Clareon单焦点、Clareon散光矫正和Clareon PanOptix。

and Clareon PanOptix Toric – all available in ultraviolet absorbing and blue light filtering foldable options.

并且Clareon PanOptix Toric – 都有紫外线吸收和蓝光过滤的可折叠选项。

Clareon Vivity is inserted using Clareon Monarch

Clareon Vivity 使用 Clareon Monarch 插入。

IV, an easy-to-use, reusable manual delivery system, and is also available in the AutonoMe

IV,一个易于使用、可重复使用的手动输送系统,并且在AutonoMe中也可用。

Automated Pre-Loaded Delivery System.

自动预加载递送系统。

About Cataracts

关于白内障

A cataract is a cloudy area in the natural lens of the eye that affects vision. As a cataract develops, the eye's lens gradually becomes hard and cloudy, allowing less light to pass through, which makes it more difficult to see. Most cataracts result from normal aging, but radiation exposure, steroid use, diabetes and eye trauma can accelerate their development..

白内障是眼睛自然晶状体中影响视力的浑浊区域。随着白内障的发展,眼睛的晶状体会逐渐变硬和模糊,允许通过的光线减少,使视力更加困难。大多数白内障是由正常的衰老过程引起的,但辐射暴露、类固醇使用、糖尿病和眼部创伤会加速其发展。

Cataracts are the most common age-related eye condition and the leading cause of preventable blindness.

白内障是最常见的眼部年龄相关疾病,也是可预防性失明的主要原因。

Cataracts are treated by removing the eye's cloudy natural lens and surgically replacing it with an intraocular lens (IOL). More than 92% of cataract surgeries are considered successful, and patients typically return to their normal routines within 24 hours.

白内障的治疗是通过移除眼睛混浊的天然晶状体,并通过手术用人工晶体(IOL)替换它。超过92%的白内障手术被认为是成功的,患者通常在24小时内恢复正常生活。

About Vivity

关于Vivity

The non-diffractive Clareon Vivity Extended Vision Hydrophobic Posterior Chamber IOLs (referred to as Clareon Vivity) and AcrySof IQ Vivity Extended Vision Posterior Chamber Intraocular Lens Model DFT015 (referred to as AcrySof IQ Vivity IOL) are UV-absorbing and blue-light-filtering foldable intraocular lenses (IOLs).

非衍射型Clareon Vivity延长视力疏水性后房人工晶状体(简称Clareon Vivity)和AcrySof IQ Vivity延长视力后房人工晶状体型号DFT015(简称AcrySof IQ Vivity IOL)是吸收紫外线和过滤蓝光的可折叠人工晶状体(IOL)。

Vivity IOL provides an extended range of vision from distance to near, with low levels of visual disturbances..

Vivity人工晶体提供了从远到近的扩展视力范围,且视觉干扰程度较低。

Potential side effects:

可能的副作用:

As with any surgery, there is an implicit risk, whether or not the IOL is implanted. The complications of the IOL implantation surgery ranges from minor side effects (usually temporary) to serious complications.

任何手术都有隐含的风险,无论是否植入人工晶体。人工晶体植入手术的并发症范围从轻微副作用(通常是暂时性的)到严重并发症不等。

Patients with previous illnesses or disorders (such as chronic infections of the eye or eyelids, or diabetes) may present a higher risk of complications. Temporary surgical complications include, but are not limited to, reactions to medications such as irritation or mild allergic response, bleeding, redness, itching of the eye, sensitivity to light, swelling, corneal edema (swelling of the cornea), problems with the iris, cell growth in the IOL, and an increase temporary eye pressure.

患有先前疾病或病症(如眼部或眼睑的慢性感染或糖尿病)的患者可能面临更高的并发症风险。暂时性的手术并发症包括但不限于对药物的反应,如刺激或轻微过敏反应、出血、发红、眼部瘙痒、光敏感、肿胀、角膜水肿(角膜肿胀)、虹膜问题、人工晶体细胞生长以及短暂的眼压升高。

There is a small risk of needing further surgical treatment after the implantation of the initial IOL..

在植入初始人工晶体后,存在需要进一步手术治疗的小风险。

Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the benefit/risk ratio before implanting a lens in a patient with ocular comorbidities as indicated in the IFU.

外科医生应通过仔细的术前评估和可靠的临床判断,来决定在患有眼部合并症的患者中植入晶状体的收益/风险比,如IFU所示。

About Alcon

关于爱尔康

Alcon helps people see brilliantly. As the global leader in eye care with a heritage spanning over 75 years, we offer the broadest portfolio of products to enhance sight and improve people’s lives. Our Surgical and Vision Care products touch the lives of more than 260 million people in over 140 countries each year living with conditions like cataracts, glaucoma, retinal diseases and refractive errors.

爱尔康帮助人们清晰看世界。作为拥有超过75年历史的全球眼科护理领导者,我们提供最广泛的产品组合以增强视力并改善人们的生活。我们的外科和视力保健产品每年惠及140多个国家中超过2.6亿受白内障、青光眼、视网膜疾病和屈光不正等问题困扰的人们。

Our more than 25,000 associates are enhancing the quality of life through innovative products, partnerships with Eye Care Professionals and programs that advance access to quality eye care. Learn more at .

我们的25,000多名员工通过创新的产品、与眼科护理专业人士的合作以及提升优质眼科护理可及性的项目,正在改善人们的生活质量。欲了解更多信息,请访问。