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<article article-type="research-article" dtd-version="1.3" xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xml:lang="ru"><front><journal-meta><journal-id journal-id-type="publisher-id">ophthalmology</journal-id><journal-title-group><journal-title xml:lang="ru">Офтальмология</journal-title><trans-title-group xml:lang="en"><trans-title>Ophthalmology in Russia</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">1816-5095</issn><issn pub-type="epub">2500-0845</issn><publisher><publisher-name>Ophthalmology</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.18008/1816-5095-2020-4-711-718</article-id><article-id custom-type="elpub" pub-id-type="custom">ophthalmology-1362</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="ru"><subject>ОФТАЛЬМОХИРУРГИЯ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>OPHTHALMOSURGERY</subject></subj-group></article-categories><title-group><article-title>Отдаленные результаты ReLEx® SMILE при различной степени корригируемой миопии</article-title><trans-title-group xml:lang="en"><trans-title>The Long-Term Results of ReLEX® SMILE Depending on the Degree of the Corrected Myopia</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Клокова</surname><given-names>О. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Klokova</surname><given-names>O. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>кандидат медицинских наук, заведующая отделением лазерной рефракционной хирургии,</p><p>ул. Красных партизан, 6, Краснодар, 350012</p></bio><bio xml:lang="en"><p>PhD, head of the laser refractive surgery department,</p><p>Krasnykh Partizan str., 6, Krasnodar, 350012</p></bio><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Дамашаускас</surname><given-names>Р. О.</given-names></name><name name-style="western" xml:lang="en"><surname>Damashauskas</surname><given-names>R. O.</given-names></name></name-alternatives><bio xml:lang="ru"><p>врач-офтальмолог отделения лазерной рефракционной хирургии,</p><p>ул. Красных партизан, 6, Краснодар, 350012</p></bio><bio xml:lang="en"><p>ophthalmosurgion at the laser refractive surgery department,</p><p>Krasnykh Partizan str., 6, Krasnodar, 350012</p></bio><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Костенев</surname><given-names>С. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Kostenev</surname><given-names>S. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>доктор медицинских наук, старший научный сотрудник отдела лазерной рефракционной хирургии,</p><p>Бескудниковский бульвар, 59а, Москва, 127486</p></bio><bio xml:lang="en"><p>MD, Professor,senior research officer of the laser refractive surgery department,</p><p>Beskudnikovsky blvd, 59а, Moscow, 127486</p></bio><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Калайдин</surname><given-names>Е. Н.</given-names></name><name name-style="western" xml:lang="en"><surname>Kalaidin</surname><given-names>E. N.</given-names></name></name-alternatives><bio xml:lang="ru"><p>доктор физико-математических наук, профессор кафедры прикладной математики,</p><p>ул. Ставропольская, 149, Краснодар, 350040</p></bio><bio xml:lang="en"><p>Doctor of physical and mathematical sciences, Professor of department of applied mathematics,</p><p>Stavropolskaya str., 149, Krasnodar, 350040</p></bio><xref ref-type="aff" rid="aff-3"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>Краснодарский филиал ФГАУ НМИЦ «МНТК “Микрохирургия глаза” им. академика С.Н. Федорова» Министерства здравоохранения Российской Федерации</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Krasnodar Branch of The S. Fyodorov Eye Microsurgery Federal State Institution</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru"><institution>ФГАУ НМИЦ «МНТК “Микрохирургия глаза” им. академика С.Н. Федорова» Министерства здравоохранения Российской Федерации</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Eye Microsurgery Federal State Institution</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-3"><aff xml:lang="ru"><institution>ФГБОУ ВО «Кубанский государственный университет»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Kuban State University</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2020</year></pub-date><pub-date pub-type="epub"><day>25</day><month>12</month><year>2020</year></pub-date><volume>17</volume><issue>4</issue><fpage>711</fpage><lpage>718</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Клокова О.А., Дамашаускас Р.О., Костенев С.В., Калайдин Е.Н., 2020</copyright-statement><copyright-year>2020</copyright-year><copyright-holder xml:lang="ru">Клокова О.А., Дамашаускас Р.О., Костенев С.В., Калайдин Е.Н.</copyright-holder><copyright-holder xml:lang="en">Klokova O.A., Damashauskas R.O., Kostenev S.V., Kalaidin E.N.</copyright-holder><license xml:lang="ru" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>Данная работа распространяется под лицензией Creative Commons Attribution 4.0.</license-p></license><license xml:lang="en" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>This work is licensed under a Creative Commons Attribution 4.0 License.</license-p></license></permissions><self-uri xlink:href="https://www.ophthalmojournal.com/opht/article/view/1362">https://www.ophthalmojournal.com/opht/article/view/1362</self-uri><abstract><sec><title>Цель</title><p>Цель. Проспективное исследование отдаленных рефракционных и визуальных результатов ReLEx® SMILE при различной степени корригируемой миопии.</p></sec><sec><title>Пациенты и методы</title><p>Пациенты и методы. В три исследуемые группы вошел 71 пациент, средний возраст 26,48 ± 5,5 года I группу составили 20 пациентов (39 глаз), средний сферический эквивалент (СЭ) –2,62 ± 0,87 D, II группу — 26 пациентов (51 глаз), средний СЭ –4,68 ± 0,74 D, III группу — 25 пациента (47 глаз), средний СЭ –6,88 ± 0,72 D. С помощью лазерной системы VisuMax™ (Carl Zeiss Meditec AG) всем пациентам была выполнена фемтолазерная коррекция миопии методом ReLEx® SMILE.</p></sec><sec><title>Результаты</title><p>Результаты. Некорригированная острота зрения 0,9–1,0 была определена в I группе на 34 глазах (87,2 %), во II — на 43 (84,3 %), в III — на 37 (78,7 %). Коэффициент эффективности был равен 1,0 в I–II группе и 0,89 — в III группе. Снижение корригированной остроты зрения (КОЗ) при коррекции слабой и средней степени миопии отмечено не было, таким образом, коэффициент безопасности составил 1,0; в III группе зафиксировано снижение на 0,1 в двух случаях (4 %), на 0,2 — в одном случае (2 %), коэффициент безопасности 0,98. Через два года после ReLEx® SMILE рефракция ± 0,5 D от запланированной в исследуемых группах была достигнута соответственно в 94,9, 88,2, 76,6 % случаев, ±1,0 D в I и II группе в 100 % случаев, в 97 % — в III группе. Коэффициент предсказуемости составил в I группе 0,95, во II — 0,9, в III — 0,77. Рефракционный регресс по сравнению с результатами через 1 месяц после операции составил в I группе 0,08 D, во II — 0,1 D, в III — 0,16 D. Анализ отдаленных результатов ReLEx® SMILE позволяет сделать</p></sec><sec><title>Заключение</title><p>Заключение: метод безопасен и эффективен, обеспечивает высокую предсказуемость рефракционных результатов при коррекции различной степени миопии. Дальнейшее изучение отдаленных результатов операции, создание и использование номограмм, учитывающих индивидуальные особенности роговицы, позволит улучшить предсказуемость и стабильность рефракционных результатов при коррекции миопии высокой степени. </p></sec></abstract><trans-abstract xml:lang="en"><sec><title>The purpose</title><p>The purpose: prospective study of the long-term refractive and visual results of ReLEx® SMILE, depending on the degree of corrected myopia.</p></sec><sec><title>Material and methods</title><p>Material and methods. The three study groups included 71 patients; the mean age was 26.48 ± 5.5 years. Group I consisted of 20 patients (39 eyes) mean SE –2.62 ± 0.87 D, group II — 26 patients (51 eyes), mean SE 4.68 ± 0.74 D, Group III — 25 patients (47 eyes), mean SE 6.88 ± 0.72 D. All patients underwent femtolaser correction of myopia using the ReLEx® SMILE method with the VisuMax™ laser system (Carl Zeiss Meditec AG).</p></sec><sec><title>Results</title><p>Results. Uncorrected visual acuity of 09 — 1.0 was noted in 34 eyes (87.2 %) in group I, in II — in 43 eyes (84.3 %), in 37 eyes (78.7 %) in group III. The efficiency coefficient was 1.0 in groups I — II and 0.89 in group III. There was no decrease in corrected visual acuity (CVA) during the correction of mild and moderate myopia, in group III it was recorded by 0.1 in two cases (4 %), by 0.2 in one case (2 %), the safety factor in I — II groups 1.0, in III 0,89. Two years after ReLEx® SMILE, refraction of ± 0.5 D from planned in the study groups was achieved, respectively, in 94.9, 88.2, 76.6 % of cases, ± 1.0 D in 100 % of cases in I, II groups, in 97 % of cases in III group. The predictability coefficient was 0.95 in group I, 0.88 in group II, and 0.77 in group III. Refractive regression compared with the results 1 month postoperatively was 0.08 D in group I, 0.1 D in group II, and 0.16 D in group III. Analysis of the long-term results of ReLEx® SMILE allows us to conclude: the method is safe and effective, provides high predictability of refractive results in correcting various degrees of myopia. Further study of the long-term results of the operation, the creation and use of nomograms, taking into account the individual characteristics of the cornea, will improve the predictability and stability of refractive results in the correction of high myopia. </p></sec></trans-abstract><kwd-group xml:lang="ru"><kwd>ReLEx® SMILE</kwd><kwd>миопия</kwd><kwd>отдаленные результаты</kwd><kwd>регресс рефракционного эффекта</kwd></kwd-group><kwd-group xml:lang="en"><kwd>ReLEx® SMILE</kwd><kwd>myopia</kwd><kwd>long-term results</kwd><kwd>regression of the refractive effect</kwd></kwd-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">Sekundo W., Kunert K.S., Blum M. Small incision corneal refractive surgery using the small incision lenticule extraction (SMILE) procedure for the correction of myopia and myopic astigmatism: results of a 6 month prospective study. British Journal of Ophthalmology. 2011;95(3):335–339. DOI: 10.1136/bjo.2009.174284</mixed-citation><mixed-citation xml:lang="en">Sekundo W., Kunert K.S., Blum M. Small incision corneal refractive surgery using the small incision lenticule extraction (SMILE) procedure for the correction of myopia and myopic astigmatism: results of a 6 month prospective study. British Journal of Ophthalmology. 2011;95(3):335–339. DOI: 10.1136/bjo.2009.174284</mixed-citation></citation-alternatives></ref><ref id="cit2"><label>2</label><citation-alternatives><mixed-citation xml:lang="ru">Reinstein D.Z., Archer T.J., Gobbe M. Small incision lenticule extraction (SMILE) history, fundamentals of a new refractive surgery technique and clinical outcomes. Eye and Vision. 2014;1:3. DOI: 10.1186/s40662-014-0003-1</mixed-citation><mixed-citation xml:lang="en">Reinstein D.Z., Archer T.J., Gobbe M. Small incision lenticule extraction (SMILE) history, fundamentals of a new refractive surgery technique and clinical outcomes. Eye and Vision. 2014;1:3. DOI: 10.1186/s40662-014-0003-1</mixed-citation></citation-alternatives></ref><ref id="cit3"><label>3</label><citation-alternatives><mixed-citation xml:lang="ru">Rupal Shah, MS. History and results; Indications and contraindications of SMILE compared with LASIK. Asia-Pacific Journal of Ophthalmology. 2019;8(5):371–376. DOI: 10.1097/01.APO.0000580132.98159.fa</mixed-citation><mixed-citation xml:lang="en">Rupal Shah, MS. History and results; Indications and contraindications of SMILE compared with LASIK. Asia-Pacific Journal of Ophthalmology. 2019;8(5):371–376. DOI: 10.1097/01.APO.0000580132.98159.fa</mixed-citation></citation-alternatives></ref><ref id="cit4"><label>4</label><citation-alternatives><mixed-citation xml:lang="ru">Kamiya K., Shimizu K., Igarashi A., Kobashi H. Visual and refractive outcomes of femtosecond lenticule extraction and small-incision lenticule extraction for myopia. American Journal of Ophthalmology. 2014;157:128–134. DOI: 10.1016/j.ajo.2013.08.011</mixed-citation><mixed-citation xml:lang="en">Kamiya K., Shimizu K., Igarashi A., Kobashi H. Visual and refractive outcomes of femtosecond lenticule extraction and small-incision lenticule extraction for myopia. American Journal of Ophthalmology. 2014;157:128–134. DOI: 10.1016/j.ajo.2013.08.011</mixed-citation></citation-alternatives></ref><ref id="cit5"><label>5</label><citation-alternatives><mixed-citation xml:lang="ru">Hansen R.S, Lyhne N., Grauslund J. Small-incision lenticule extraction (SMILE): outcomes of 722 eyes treated for myopia and myopic astigmatism. Graefe’s Archive for Clinical and Experimental Ophthalmology. 2016;254:399–405. DOI: 10.1007/s00417-015-3226-5</mixed-citation><mixed-citation xml:lang="en">Hansen R.S, Lyhne N., Grauslund J. Small-incision lenticule extraction (SMILE): outcomes of 722 eyes treated for myopia and myopic astigmatism. Graefe’s Archive for Clinical and Experimental Ophthalmology. 2016;254:399–405. DOI: 10.1007/s00417-015-3226-5</mixed-citation></citation-alternatives></ref><ref id="cit6"><label>6</label><citation-alternatives><mixed-citation xml:lang="ru">Chon J.K., Hamilton D.R. SMILE for myopic astigmatism: Early experience in the USA and international advances. Current Ophthalmology Reports. 2020. DOI: 10.1007/s40135-020-00250-0</mixed-citation><mixed-citation xml:lang="en">Chon J.K., Hamilton D.R. SMILE for myopic astigmatism: Early experience in the USA and international advances. Current Ophthalmology Reports. 2020. DOI: 10.1007/s40135-020-00250-0</mixed-citation></citation-alternatives></ref><ref id="cit7"><label>7</label><citation-alternatives><mixed-citation xml:lang="ru">Blum M., Täubig K., Gruhn C., Sekundo W., Kunert K.S. Five-year results of small incision lenticule extraction (ReLEx SMILE). The British journal of ophthalmology. 2016;100:1192–1195. DOI: 10.1136/bjophthalmol-2015-306822</mixed-citation><mixed-citation xml:lang="en">Blum M., Täubig K., Gruhn C., Sekundo W., Kunert K.S. Five-year results of small incision lenticule extraction (ReLEx SMILE). The British journal of ophthalmology. 2016;100:1192–1195. DOI: 10.1136/bjophthalmol-2015-306822</mixed-citation></citation-alternatives></ref><ref id="cit8"><label>8</label><citation-alternatives><mixed-citation xml:lang="ru">Pedersen I.B., Ivarsen A., Hjortdal J. Three-year results of small incision lenticule extraction for high myopia: refractive outcomes and aberrations. Journal of Refractive Surgery. 2015;31:719–724. DOI: 10.3928/1081597X-20150923-11</mixed-citation><mixed-citation xml:lang="en">Pedersen I.B., Ivarsen A., Hjortdal J. Three-year results of small incision lenticule extraction for high myopia: refractive outcomes and aberrations. Journal of Refractive Surgery. 2015;31:719–724. DOI: 10.3928/1081597X-20150923-11</mixed-citation></citation-alternatives></ref><ref id="cit9"><label>9</label><citation-alternatives><mixed-citation xml:lang="ru">Качанов А.Б., Никулин С.А. Технология ReLEx® SMILE — эволюция хирургической коррекции близорукости. Офтальмохирургия. 2017;3:31–37. DOI: 10.25276/0235-4160-2017-3-31-37</mixed-citation><mixed-citation xml:lang="en">Kachanov A.B., Nikulin S.A. ReLEx® SMILE technology — evolution of surgical correction of myopia. Ophthalmosurgery = Oftal’mohiryrgiya. 2017;3:31–37 (In Russ.). DOI: 10.25276/0235-4160-2017-3-31-37</mixed-citation></citation-alternatives></ref><ref id="cit10"><label>10</label><citation-alternatives><mixed-citation xml:lang="ru">Эскина Э.Н., Давтян К.К. Алгоритм выбора параметров при операции ReLEx SMILE. Результаты ReLEx SMILE при миопии слабой степени. Современные технологии в офтальмологии. 2017;3:158–161. OAI-PMH ID: oai:eyepress. ru:article24663</mixed-citation><mixed-citation xml:lang="en">Eskina E.N., Davtyan K.K. Algorithm for choosing parameters for ReLEx SMILE surgery. ReLEx SMILE results in mild myopia. Modern technologies in ophthalmology  = Sovremennie tehnologii v oftal’mologii. 2017;3:158–161 (In Russ.). OAI-PMH ID: oai:eyepress. ru:article24663</mixed-citation></citation-alternatives></ref><ref id="cit11"><label>11</label><citation-alternatives><mixed-citation xml:lang="ru">Ganesh S., Brar S., Arra R.R. Refractive lenticule extraction small incision lenticule extraction: A new refractive surgery paradigm. Indian Journal of Ophthalmology. 2018;66(1):10–19. DOI: 10.4103/ijo.IJO_761_17</mixed-citation><mixed-citation xml:lang="en">Ganesh S., Brar S., Arra R.R. Refractive lenticule extraction small incision lenticule extraction: A new refractive surgery paradigm. Indian Journal of Ophthalmology. 2018;66(1):10–19. DOI: 10.4103/ijo.IJO_761_17</mixed-citation></citation-alternatives></ref><ref id="cit12"><label>12</label><citation-alternatives><mixed-citation xml:lang="ru">Nagaraja, Harsha; Mehta, Jodhbir S.; Zhou, Xingtao; Yam, Jason C.; Lam, Dennis S.C. Will SMILE become the new benchmark of corneal laser refractive surgery? Asia-Pacific Journal of Ophthalmology: 2019;8(5):351–354. DOI: 10.1097/01.APO.0000579956.14784.91</mixed-citation><mixed-citation xml:lang="en">Nagaraja, Harsha; Mehta, Jodhbir S.; Zhou, Xingtao; Yam, Jason C.; Lam, Dennis S.C. Will SMILE become the new benchmark of corneal laser refractive surgery? Asia-Pacific Journal of Ophthalmology: 2019;8(5):351–354. DOI: 10.1097/01.APO.0000579956.14784.91</mixed-citation></citation-alternatives></ref><ref id="cit13"><label>13</label><citation-alternatives><mixed-citation xml:lang="ru">Messerschmidt-Roth A., Sekundo W., Lazaridis A., Schulze S. Three years followup study after refractive small incision lenticule extraction (SMILE) using 500kHz femtosecond laser in “fast mode”. Klinische Monatsblätter Für Augenheilkunde. 2017;234:102–108. DOI: 10.1055/s-0042-117281</mixed-citation><mixed-citation xml:lang="en">Messerschmidt-Roth A., Sekundo W., Lazaridis A., Schulze S. Three years followup study after refractive small incision lenticule extraction (SMILE) using 500kHz femtosecond laser in “fast mode”. Klinische Monatsblätter Für Augenheilkunde. 2017;234:102–108. DOI: 10.1055/s-0042-117281</mixed-citation></citation-alternatives></ref><ref id="cit14"><label>14</label><citation-alternatives><mixed-citation xml:lang="ru">Chansue E., Tanehsakdi M., Swasdibutra S., McAlinden C. Efficacy, predictability and safety of small incision lenticule extraction (SMILE). Eye and Vision. 2015;2:14. DOI: 10.1186/s40662-015-0024-4</mixed-citation><mixed-citation xml:lang="en">Chansue E., Tanehsakdi M., Swasdibutra S., McAlinden C. Efficacy, predictability and safety of small incision lenticule extraction (SMILE). Eye and Vision. 2015;2:14. DOI: 10.1186/s40662-015-0024-4</mixed-citation></citation-alternatives></ref><ref id="cit15"><label>15</label><citation-alternatives><mixed-citation xml:lang="ru">Tian Han, Ye Xu, Xiao Han, Li Zeng, Jianmin Shang, Xun Chen, Xingtao Zhou. Three-year outcomes of small incision lenticule extraction (SMILE) and femtosecond laser-assisted laser in situ keratomileusis (FS-LASIK) for myopia and myopic astigmatism. British Journal of Ophthalmology. 2019;103(4):565–568. DOI: 10.1136/bjophthalmol-2018-312140</mixed-citation><mixed-citation xml:lang="en">Tian Han, Ye Xu, Xiao Han, Li Zeng, Jianmin Shang, Xun Chen, Xingtao Zhou. Three-year outcomes of small incision lenticule extraction (SMILE) and femtosecond laser-assisted laser in situ keratomileusis (FS-LASIK) for myopia and myopic astigmatism. British Journal of Ophthalmology. 2019;103(4):565–568. DOI: 10.1136/bjophthalmol-2018-312140</mixed-citation></citation-alternatives></ref><ref id="cit16"><label>16</label><citation-alternatives><mixed-citation xml:lang="ru">Kim J.R, Kim B.K, Mun S.J. One-year outcomes of small-incision lenticule extraction (SMILE): mild to moderate myopia vs. high myopia. BMC Ophthalmology. 2015;15:59. DOI: 10.1186/s12886-015-0051-x 17. Ağca A., Tülü B., Yaşa D. Long-term (5 years) follow-up of small-incision lenticule extraction in mild-to-moderate myopia. Journal of Cataract and Refractive Surgery. 2019;45:421–426. DOI: 10.1016/j.jcrs.2018.11.010</mixed-citation><mixed-citation xml:lang="en">Kim J.R, Kim B.K, Mun S.J. One-year outcomes of small-incision lenticule extraction (SMILE): mild to moderate myopia vs. high myopia. BMC Ophthalmology. 2015;15:59. DOI: 10.1186/s12886-015-0051-x 17. Ağca A., Tülü B., Yaşa D. Long-term (5 years) follow-up of small-incision lenticule extraction in mild-to-moderate myopia. Journal of Cataract and Refractive Surgery. 2019;45:421–426. DOI: 10.1016/j.jcrs.2018.11.010</mixed-citation></citation-alternatives></ref></ref-list><fn-group><fn fn-type="conflict"><p>The authors declare that there are no conflicts of interest present.</p></fn></fn-group></back></article>
