—在俄罗斯是否使用小切口小Kong镜提取方法完成了微创激光视力矫正手术？ ( — Are small-invasive laser vision correction operations done in Russia using the Small Incision Lenticule Extraction method?)

Yes, about 10 years already. Every year, more and more at conferences of ophthalmologists, questions arise not at the level of “What is this?”, But at specific practical nuances of technology. VisuMax lasers exist in several clinics in Russia, but it is much less used under ReLEx SMILE than under femtoLASIK. Historically, it happened in Russia that this technology is little used in the central part and is actively used beyond the Urals.

是的，大约十年了。 每年，在眼科医生会议上越来越多地，问题不是出现在“这是什么？”的水平上，而是出现在特定的技术实际细微差别上。 俄罗斯的几家诊所中都使用VisuMax激光器，但ReLEx SMILE之下使用的激光器要比femtoLASIK少得多。 从历史上看，在俄罗斯曾发生过这项技术在中部地区很少使用，而在乌拉尔地区以外得到积极使用的情况。

—特定操作许可的故事是什么？ ( — What is the story with licenses for specific operations?)

Zeiss sells cones with licenses. A cone — a replacement part adjacent to the eye — is purchased with a license to use a laser procedure, usually in batches of 10 or 100 operations. For example, 10 cones and 10 licenses are received. Licenses are driven through the laser menu, and it allows you to use the appropriate cones for the appropriate program types. Licenses for SMILE separately, for femtoLASIK separately, for FLEX, rings and additional corrections are also separate licenses. Most manufacturers of femtosecond and some excimer lasers have a similar situation. Licenses for excimer operations are not needed, perhaps, except on models of about 5 years old and older.

蔡司出售带许可证的锥体。 购买带有视力的许可使用视锥细胞的锥体(眼睛附近的替换部件)，通常以10或100次分批操作。 例如，会收到10个锥体和10个许可证。 许可证是通过激光菜单驱动的，它允许您将适当的锥体用于适当的程序类型。 单独的SMILE许可证，单独的femtoLASIK许可证，FLEX许可证，振铃和其他更正也是单独的许可证。 飞秒的大多数制造商和一些准分子激光器也有类似的情况。 可能不需要准分子操作的许可证，除非大约5岁或更老的型号除外。

—并且您无法获得SMILE的此类许可？ ( — And you can not get such a license for SMILE?)

Easily. Firstly, this module in the laser is as an expensive option, so the device itself without the SMILE option is cheaper. Secondly, if this option is available, then licenses to carry out the operation ReLEx SMILE can be acquired only after conducting 5–10 test runs on pig eyes, then performing at least 10 femtoLASIK operations on patients, then 50 FLEX operations, and only after that Buy a SMILE license for a specific surgeon.

容易。 首先，激光器中的该模块是昂贵的选件，因此不带SMILE选件的设备本身也更便宜。 其次，如果此选项可用，则只有在对猪眼进行5–10次测试运行，然后对患者至少执行10次femtoLASIK操作，然后再进行50次FLEX操作，并且仅在进行之后，才能获得执行ReLEx SMILE操作的许可为特定外科医生购买SMILE许可证。

-我想出了解决方法... ( — I figured out how to get around this ...)

The license for SMILE costs 200–300 euros per eye in different regions of the world. It will not work out two operations instead of one, it will not be possible to make SMILE under the femtoLASIK license. In the event of a technical failure of the accounting system of operations or problems with the firmware, the spent licenses are not returned (in case someone calls “warranty” cases of breakdowns).

在世界不同地区，SMILE的许可费用为每只眼睛200-300欧元。 它无法完成两项操作，而不是一项操作，因此无法在femtoLASIK许可下进行SMILE。 如果运营会计系统出现技术故障或固件出现问题，则不退还用完的许可证(以防有人称其为“保修”故障情况)。

—为什么一切安排得如此奇怪？ ( — Why is everything so strangely arranged?)

Because SMILE is now a new and expensive technology, it is also the safest in terms of the risk of irreversible side effects. Well, and corresponds to the trends in surgery in general — the transition to endoscopic technique, and not through a large incision. As a result of the technology itself — there are requirements for the manual skills of surgeons. And 90 out of 100 surgeons-ophthalmologists who massively perform operations on excimer lasers have long done nothing with their hands. That is, it is much easier to master the technology for those involved in standard eye microsurgery — cataract operations, glaucoma, and so on. Accordingly, the clinics have a question — either to sell at a low price with a low cost of the surgeon’s work, retraining the “ordinary” laser specialist, or not to invest in expensive “space” equipment and offer operations to their patients using old, traditional technologies. Even harder, for example, in the UK — correction clinics for the most part do not train their doctors. Equipment is purchased there, and then practitioners nearby are invited as freelancers to specific operations. They do not diagnose them, they are given an opinion on the patient, the laser and an hour of time. Everything, operation is ready.

由于SMILE现在是一项新的昂贵技术，因此就不可逆副作用的风险而言，它也是最安全的。 好吧，并且与一般的手术趋势相对应-向内窥镜技术的过渡，而不是通过大切口。 由于技术本身的存在，因此需要外科医生的手工技能。 在100个使用准分子激光进行大规模手术的外科医生眼科医师中，有90％长期以来没有采取任何措施。 也就是说，对于那些参与标准眼部显微外科手术的人员(白内障手术，青光眼等)掌握该技术要容易得多。 因此，诊所存在一个问题：要么以低廉的价格以低廉的工作成本进行销售，要么对“普通”激光专家进行培训，要么不投资昂贵的“太空”设备，而是使用旧的设备为其患者提供手术，传统技术。 例如，在英国就更难了-矫正诊所大多不培训医生。 在那里购买设备，然后邀请附近的从业人员作为自由职业者进行特定操作。 他们没有诊断出他们，他们得到了患者，激光和一个小时的时间的意见。 一切就绪，操作就绪。

—外科医生的技能究竟会产生什么影响？ ( — What exactly does the surgeon's skill influence?)

The accuracy of the separation of lenticles in parametric geometry is when it is already formed by two laser cuts from the bottom and from the top, and it needs to be taken out of the cut from the side.

参数化几何形状中的双凸透镜的分离精度是当已经由底部和顶部的两个激光切割形成的，并且需要从侧面将其从切割中取出时。

The cavitation cut is 10–15 microns, it is not always smooth, there are points of tissue glazing (according to manual sensations, like the lightest, slightly damp napkin lays on the table).

空化切口为10–15微米，并不总是很光滑，有一些薄纸组织(根据手动感觉，例如桌子上最轻，略微潮湿的餐巾纸)。

Accordingly, if the surgeon is inexperienced, then he has two options: to risk tissue injuries when manipulating the spatula is a bad option, or to set up such regimes when the lenticule is detached and taken out much easier. This means that a larger incision can be used (Walter Sekundo, as an inventor and a long-term practice with very significant experience and more complex other manual operations, insists on a 2.5 mm incision. However, in Russia they do 4.5 mm, or “Wildly” for him — 6 mm). On the other hand, by the way, an ophthalmologist with an incredibly extensive experience in operations Rupal Sha from India makes an entrance of only 1.5 mm, and gets a lenticle through this incision.

因此，如果外科医生经验不足，那么他有两种选择：在用小铲操作时，冒着组织受伤的风险是一种不好的选择；或者在小透镜脱离并容易取出时建立这样的治疗方案。 这意味着可以使用更大的切口(作为发明者和长期实践的Walter Sekundo，他拥有非常丰富的经验和更复杂的其他手动操作，坚持使用2.5毫米切口。但是，在俄罗斯，这种切口是4.5毫米，或者对他“疯狂”-6毫米)。 另一方面，来自印度的Rupal Sha在操作方面具有非常丰富的经验，其眼科医师仅可进入1.5毫米的入口，并通过该切口获得了双凸透镜。

The second option to facilitate lenticular secretion — an unjustified change in laser frequency, which gives a “roasted” cornea due to greater heat absorption by the bowman membrane tissues, and increases the risk of side effects (innervation disorder, corneal carcass deformity) —to reduce many of the technology's benefits. By the way, the “roasted” here roughly corresponds to what the excimer laser does with LASIK or femtoLASIK. In excimer lasers during surgery, there is even a peculiar smell of “scorched tissues” and suction is used to remove gas vapors.

第二种促进晶状体分泌的选择-激光频率的不合理变化，由于弓箭手膜组织吸收的热量更大，因此会产生“烤”角膜，并增加了副作用(神经支配失调，角膜car体畸形)的风险减少了许多技术带来的好处。 顺便说一下，这里的“烤”大致相当于准分子激光器对LASIK或femtoLASIK的处理。 在手术期间的准分子激光器中，甚至有“焦烧组织”的异味，并且使用抽吸来去除气体蒸气。

There is still a chance of an error at the lenticula extraction stage. Any lenticular surgery requires certain skills, of which the easiest is to move breathing one-to-one to the beat with the patient so that the instrument in the eye remains stable.

在小扁豆提取阶段仍然有可能出错。 任何双凸透镜手术都需要某些技能，其中最简单的方法就是将呼吸与患者一对一地移动，以使眼内仪器保持稳定。

—好的，如果激光的工作频率正确，则切口为2.5–3 mm，操作的手动部分的错误率是多少？ ( — Ok, if the operating frequency of the laser is correct, the cut is 2.5–3 mm, what is the error rate in the manual part of the operation?)

The generalized probability of occurrence of complications in world practice (both reversible and irreversible together) is 0.5–1%. Apart from really “idiotic” cases with namesakes, most of the problems arise because of incorrect or insufficient diagnostics (probably putting the wrong patient on the table is also part of the diagnosis, right?). The most unpleasant irreversible complication is the corneal protrusion due to the loss of stiffness of the frame, that is, a significant violation of its biomechanics. It is possible if the patient has either miraculously passed diagnostics with an error, or if a defect of the stroma is opened, which could not be recognized by existing scanners (by the way, the quality of the equipment for diagnostics of clinics still arises — they often try to save on this). Comprehensive preoperative examination is an important thing. According to our European standard, the clinic uses 15 different studies on devices, it takes about 2 hours, allowing you to eliminate the inaccuracy that came, for example, from other optometrists. For 15–20 minutes, only a few basic tests can be performed: in general, this could be limited to, but we really do not like surprises during operations.

在世界范围内(同时可逆和不可逆)并发症发生的广义概率为0.5-1％。 除了真正的“白痴”病例外，大多数问题都是由于诊断不正确或不足(可能将错误的患者放在桌子上也是诊断的一部分，对吧？)。 最令人不愉快的不可逆并发症是由于镜架刚度的损失所致的角膜突出，即严重违反了其生物力学。 如果患者奇迹般地通过了错误的诊断，或者如果基质的缺损被打开，而现有的扫描仪无法识别(可能，仍然存在用于临床诊断的设备的质量，则可能是这样-他们经常尝试节省此费用)。 全面的术前检查很重要。 根据我们的欧洲标准，诊所在设备上使用了15种不同的研究，大约需要2个小时，您可以消除其他视光师带来的不准确性。 在15到20分钟内，只能执行一些基本测试：通常可以将其限制在一定范围内，但是我们真的不喜欢在操作过程中出现意外情况。

-同名故事是什么？ ( — What is the story with namesakes?)

Walter Sekundo just told her last year at a conference in Moscow at the Institute of S.N.Fedorov. In one foreign clinic, the “conveyer” process confused two patients. The first with a myopia-4 and astigmatism went to LASIK, received a correction, and only at the end a local performer understood the error. The doctor then claimed: «My optometrist is to blame.» Walter was called to correct what they had done, and he had only one question when analyzing the operation, and he came down to why this most attentive doctor did not control everything himself.

沃尔特·塞昆多(Walter Sekundo)去年在莫斯科SNFedorov研究所的一次会议上告诉她。 在一家外国诊所中，“传送带”过程使两名患者感到困惑。 第一个患有近视4和散光的人去了LASIK，接受了矫正，直到最后，当地的表演者才理解了这个错误。 然后医生声称：“我的视光师应受责备。” 沃尔特被要求纠正他们所做的事情，而他在分析手术时只有一个问题，他得出了为什么这位最细心的医生不能自己掌控一切的原因。

Walter himself, by the way, understands (as I do) that our names are written directly in the names of the clinics, and the name there is a full responsibility. In the case of Walter, not only for the clinic, but also for the whole technology, he checks everything manic and calm three times. Colleagues joke about him — “Three hundred percent German.” This is due to the three-time verification protocol, mandatory for SMILE, performed under a license.

顺便说一句，沃尔特本人(就像我一样)理解我们的名字直接写在诊所的名字上，这个名字是完全负责的。 就沃尔特而言，不仅是诊所，而且是整个技术，他都要检查所有躁狂和镇静三遍。 同事们开玩笑说：“百分之三百的德国人。” 这是由于在许可证下对SMILE强制执行的三次验证协议。

—如果在提取或分离过程中小透镜破裂，会发生什么？ ( — What will happen if the lenticule bursts during extraction or separation?)

This will somewhat complicate the work, but in experienced hands nothing serious. In general, it can be extracted in parts, but in its entirety — faster, easier and more comfortable for the patient.

这会使工作复杂化，但是在经验丰富的人员手中没有什么严重的。 通常，它可以部分提取，但可以全部提取-对患者而言更快，更轻松，更舒适。

—外科医生从ReLEX的FLEX方法中学到什么？ ( — What do surgeons learn from FLEX-methods for ReLEX?)

On pig eyes, because they have the most similar to the human cornea. In Turkey — on sheep's eyes. Training «patients» are delivered to the operating room without the rest of the pig. Then there are patients who are fully aware of the risk (most often they are acquaintances whom the doctor performs the operation for free — or people who are in the queue for a free correction for such cases, realizing that the risks after pigs are minimal). In this regard, the story of Walter with pigs is very remarkable. He used to treat them in the spirit of “order another half a bucket of eyes to a lecture at the slaughterhouse” — everything is rational, a pig and so dead, someone's eyes will be useful. But experiments on the development of SMILE were carried out precisely on living specimens — more precisely, they were evaluated for long-term effects. We received permission from the ethics commission, received pigs, and took the laser to the veterinary institute. They did it on the spot, took the vet to put the patients under anesthesia. At the time of the operation, the pigs were small pigs, but after 3 months of observation, they had gotten to a very impressive size. Walter Zeiss singled out two huge nurse on the wind profile, and they dragged patients, and a pretty veterinary doctor followed them. And then everything went well, and for the last proof it was necessary to do an autopsy on the already familiar pigs. According to the rules — it is necessary to kill and take away the eyes. Moreover, that additionally offended German colleagues — “to kill just like that,” because, according to the rules, it is impossible to allow prototypes for meat.

在猪眼上，因为它们与人类角膜最相似。 在土耳其-用羊的眼睛。 训练“病人”被送往手术室，而其余的猪没有。 然后，有些患者充分意识到了这种风险(大多数情况下，他们是医生免费为他们做手术的熟人，或者是正在排队免费纠正这种情况的人，他们意识到生猪后的风险很小) 。 在这方面，沃尔特与猪的故事非常出色。 他过去一直本着“命令另一只眼睛在屠宰场上演讲的精神”来对待它们的方法-一切都是理性的，猪又死了，有人的眼睛会有用。 但是，SMILE发育的实验是在活体标本上进行的，确切地说，是对它们的长期影响进行了评估。 我们得到了伦理委员会的许可，收了猪，并将激光带到了兽医学院。 他们当场做了，带兽医去给病人麻醉。 手术时，这些猪是小猪，但经过3个月的观察，它们的体型非常大。 沃尔特·蔡司(Walter Zeiss)在风向图中选出了两名巨大的护士，他们拖着病人，一位漂亮的兽医跟着他们。 然后一切进行得很顺利，对于最后的证明，有必要对已经熟悉的猪进行尸检。 根据规则-必须杀死并带走眼睛。 此外，这还冒犯了德国同事-“像那样杀人”，因为按照规则，不可能允许肉类的原型。

As for me, when a little more than 6 years ago we went to Germany to study how to do FLEX and SMILE (I studied in several centers, including the university clinic in Marburg), one simple requirement stood for the professor and creator of the technology Dr. Sekundo — at least 1000 manual operations over the past 5 years. I consistently do about 3,000 abdominal operations per year (about 10% of corrections, then a cataract, glaucoma, retinal detachment, various mechanical injuries; some operations are for 20 minutes, but there are also 1.5-2 hours). Our holding surgeons have at least a thousand operations a year.

对于我来说，大约6年前，我们去德国研究FLEX和SMILE的方法(我曾在包括马尔堡大学诊所在内的几个中心学习)中，对教授和创造者提出了一个简单的要求技术Sekundo博士-在过去5年中至少进行了1000次手动操作。 我每年大约要进行3,000次腹部手术(矫正率约为10％，然后是白内障，青光眼，视网膜脱离，各种机械损伤；有些手术需要20分钟，但也需要1.5-2个小时)。 我们的控股外科医生每年至少要进行一千次手术。

Now SMILE makes about 80% of myopia corrections in our clinic. In addition to Germany, centers with a huge number of SMILE are still in Thailand, Egypt, Turkey, India, Latin America, there is one center in China — scientific work is being conducted in these countries.

现在，SMILE在我们的诊所对近视进行了约80％的矫正。 除德国外，在泰国，埃及，土耳其，印度，拉丁美洲仍设有数量众多的SMILE中心，而在中国则有一个中心-这些国家正在进行科学研究。

—在俄罗斯其他地方有SMILE经验的人吗？ ( — Where else in Russia do people with SMILE experience?)

In Russia, 10 laser installations VisuMax, and at all, without exception, make femtoLASIK perfectly. As for SMILE, the long successful experience of work with colleagues from the branches of the IRTC of them. S.N. Fedorov in Irkutsk, Khabarovsk and Yekaterinburg. The number of SMILE operations performed is several thousand in each of them. Surgeons from these clinics are the authors of the new instruments, for example, Oleg Aleksandrovich Kostin is known for his engineering solutions — Kostin's spatula is one of the most successful instruments for today.

在俄罗斯，有10台VisuMax激光装置，并且毫无例外地使femtoLASIK完美无缺。 至于SMILE，他们与IRTC分支机构的同事长期合作的成功经验。 SN Fedorov位于伊尔库茨克，哈巴罗夫斯克和叶卡捷琳堡。 每个操作执行的SMILE操作数为数千。 这些诊所的外科医生是这些新器械的作者，例如，Oleg Aleksandrovich Kostin以其工程解决方案而闻名-Kostin的刮铲是当今最成功的器械之一。

—是否有必要做微笑？ ( — Is it necessary to do SMILE?)

Not. First of all, if you are completely satisfied with the glasses, you can not make a correction at all. They have their drawbacks, and they, and contact lenses, but more on that later. After the diagnosis, we usually do not recommend the patient the operation directly, but give forecasts and recommendations. The doctor does not decide for the patient, but gives him maximum information and the right to choose. In some cases, femtoLASIK or PRK is preferable for the indication, sometimes the choice is made because of the price, sometimes because of 30 years of clinical practice. Correspondence consultations are very approximate. Attempts to recommend some kind of operation without an accurate diagnosis of a particular patient and without understanding what kind of lifestyle he plans to lead (for example, if we learn from the patient’s history that the patient is working as a jeweler or sewing, then we change the long-term forecast accordingly). However, if with equal opportunities from a medical point of view, you choose between SMILE and femtoLASIK, the SMILE technique is statistically better. Correction accuracy on 6th generation lasers (VisuMAX) corresponds to or higher than other methods (with correction from -2 diopters, less — more precisely femtoLASIK, less than -1 — more precisely PRK), and the risk of irreversible complications is significantly lower.

不。 首先，如果您对眼镜完全满意，则根本无法进行矫正。 他们有自己的缺点，还有隐形眼镜，但以后会更多。 诊断后，我们通常不建议患者直接进行手术，而是给出预测和建议。 医生不会为患者决定，但会给他最大的信息和选择的权利。 在某些情况下，femtoLASIK或PRK更适合作为适应症，有时是因为价格而选择，有时是因为30年的临床实践。 函授咨询非常近似。 在没有准确诊断特定患者并且不了解他打算领导哪种生活方式的情况下尝试推荐某种操作(例如，如果我们从患者的历史中得知患者正在从事珠宝首饰或缝纫工作，那么我们相应地更改长期预测)。 但是，如果从医学角度来看机会均等，则可以在SMILE和femtoLASIK之间进行选择，则SMILE技术在统计学上会更好。 第六代激光器(VisuMAX)的校正精度与其他方法相当或更高(采用-2屈光度校正，更少-更精确的femtoLASIK，小于-1-更精确的PRK)，并且不可逆并发症的风险大大降低。

-我现在不敢这样做，因为与年龄有关的改变是可能的... ( — I am afraid to do now, because with age-related changes are possible ...)

One of the most common myths is that with age the “minus” will turn into a “plus” and then you probably won't need glasses. This is not true. If you simply imagine the eye as a lens system, it turns out that the cornea and the lens have the most refractive power. The optical power of the cornea in most cases varies slightly with age. The lens with its ligament apparatus is the main tool with which we examine objects in the distance and near, changing the focal length of the eye. This is similar to setting the focus in a camera. In youth, it happens easily. In the lens, changes begin to occur with age — its density, configuration, size, and transparency change. These changes in the lens of even a medically healthy person over 40 years of age result in presbyopia (age-sightedness). 100% of people are subject to this process, regardless of whether they have optics of the eye — with short-sightedness, long-sightedness, with or without astigmatism. This is manifested as:

最普遍的神话之一是，随着年龄的增长，“减号”将变成“加号”，那么您可能就不需要眼镜了。 这不是真的。 如果您简单地将眼睛想象为一个镜片系统，那么事实证明角膜和镜片具有最大的屈光力。 在大多数情况下，角膜的屈光力会随着年龄而略有变化。 具有韧带装置的晶状体是我们用来检查远处和近处物体的主要工具，从而改变了眼睛的焦距。 这类似于在相机中设置焦点。 在青年时期，它很容易发生。 在镜头中，随着年龄的增长开始发生变化-它的密度，形状，大小和透明度会发生变化。 即使是40岁以上的医学健康人士，晶状体的这些变化也会导致老花眼(视力正常)。 100％的人都会受到此过程的影响，无论他们是否拥有视力(近视，远视，有无散光)。 这表现为：

1. A man with a beautiful eyesight begins to read with glasses.一个拥有美丽视力的男人开始戴着眼镜阅读。
2. A nearsighted person stops seeing at close range, being in glasses for distance and for reading he will be forced to wear a second pair of glasses or read when removing glasses for distance and bringing the text closer to his eyes.一个近视的人停止在近距离观看，正被眼镜戴在远处并为了阅读而被迫配戴第二副眼镜，或者在移开眼镜使他靠近眼睛时被阅读。
3. Far-sighted begins to wear 2 or even 3 pairs of glasses — for distance, for medium distance (for example, for a computer) and the strongest glasses — for close distance.有远见的人开始戴2甚至3副眼镜-远距离，中距离(例如，对于计算机)和最强的眼镜-近距离。
4. The one who also has astigmatism, sees not clearly at all distances and also requires several pairs of glasses.也有散光的人，不能在所有距离看清楚，还需要几副眼镜。

Thus, presbyopia weakens the accommodation of the eye every year — the ability to focus at different distances. On average, by the age of 60, it is completely lost.

因此，老花眼每年都会削弱眼睛的适应能力-聚焦于不同距离的能力。 平均而言，到60岁时，它完全消失了。

Of course, each refractive surgeon always takes into account the patient's age when choosing a correction algorithm and method of correction, with patients of presbyopic age with transparent lenses over 45–50 years of age, the issue of the expediency of myopia’s full correction is discussed, since the residual minor undercorrection on one (non-imagined eye) or both eyes has eased would be a visual load for near. Farsightedness and astigmatism always correct completely, as they interfere with vision and into the distance and near.

当然，每位屈光外科医师在选择矫正算法和矫正方法时都会考虑患者的年龄，对于老花眼年龄在45至50岁之间的透明晶状体患者，将讨论近视眼完全矫正的权宜性问题，因为减轻了一只(未成像的眼睛)或两只眼睛上残留的轻微欠校正，将成为附近的视觉负担。 远视和散光总是会完全纠正，因为它们会干扰视力并影响远近。

翻译自: https://habr.com/en/company/klinika_shilovoy/blog/501066/