helmholtzeyeinstituteРоссийский офтальмологический журналRussian Ophthalmological Journal2072-00762587-5760Real time Publishers10.21516/2072-0076-2025-18-1-48-54helmholtzeyeinstitute-1726Research ArticleКЛИНИЧЕСКИЕ ИССЛЕДОВАНИЯCLINICAL STUDIESПервый опыт применения фиксированной комбинации левофлоксацина и кеторолака в хирургии катарактыFirst experience with a fixed combination of levofloxacin and ketorolac in cataract surgeryhttps://orcid.org/0000-0002-6393-1289НиколаенкоВ. П.NikolaenkoV. P.

Николаенко Вадим Петрович — д-р мед. наук, заместитель главного врача по офтальмологии СПб ГБУЗ «Городская многопрофильная больница № 2»; профессор кафедры оториноларингологии и офтальмологии ФГБОУ ВО «СПбГУ».

Учебный пер., д. 5, Санкт-Петербург, 194354; Университетская набережная, д. 7/9, Санкт-Петербург, 199034

Vadim P. Nikolaenko — Dr. of Med. Sci., deputy chief physician for ophthalmology, City Multidisciplinary Hospital No. 2; professor of chair of otorhinolaryngology and ophthalmology, St. Petersburg State University.

5, Uchebnyy Lane, St. Petersburg, 194354; St. Petersburg State University, 7/9, Universitetskaya Emb., St. Petersburg, 199034

https://orcid.org/0000-0003-0776-4065БеловД. Ф.BelovD. F.

Белов Дмитрий Федорович — канд. мед. наук, заведующий отделением микрохирургии (глаза) СПб ГБУЗ «Городская многопрофильная больница № 2»; ассистент кафедры оториноларингологии и офтальмологии ФГБОУ ВО «СПбГУ».

Учебный пер., д. 5, Санкт-Петербург, 194354; Университетская набережная, д. 7/9, Санкт-Петербург, 199034

Dmitri F. Belov — Cand. of Med. Sci., head of the department of eye microsurgery, City Multidisciplinary Hospital No. 2; assistant of chair of otorhinolaryngology and ophthalmology, St. Petersburg State University.

5, Uchebnyy Lane, St. Petersburg, 194354; St. Petersburg State University, 7/9, Universitetskaya Emb., St. Petersburg, 199034

belovd1990@gmail.comСПб ГБУЗ «Городская многопрофильная больница № 2»; ФГБОУ ВО «Санкт-Петербургский государственный университет»РоссияCity Multidisciplinary Hospital No. 2; St. Petersburg State UniversityRussian Federation2025270320251814854Copyright © Николаенко В.П., Белов Д.Ф., 20252025Николаенко В.П., Белов Д.Ф.Nikolaenko V.P., Belov D.F.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://roj.igb.ru/jour/article/view/1726

Цель работы — разработать алгоритм эффективного и безопасного применения фиксированной комбинации левофлоксацина и кеторолака (Сигницеф® Плюс) для профилактики инфекционных осложнений и чрезмерной воспалительной реакции после факоэмульсификации катаракты (ФЭК). Материал и методы. Исследуемую группу составили 449 пациентов (500 глаз), осмотренные на 6-е и 15-е сутки после неосложненной ФЭК сенильной катаракты. Профилактика инфекции и воспаления включала в себя четырехкратные инстилляции Сигницеф® Плюс на протяжении 5 сут и 0,1 % раствора фторметолона (Флоас Моно) — в течение 2 нед со дня операции. Первичная контрольная точка — доля пациентов с нулевой воспалительной реакцией со стороны переднего отрезка глаза, вторичные — встречаемость острого эндофтальмита, состояние глазной поверхности и переносимость препарата. Результаты. Среди пациентов исследуемой группы не отмечено ни одного случая развития острого иридоциклита или эндофтальмита. Отсутствие воспалительной реакции на 6-е и 15-е сутки зарегистрировано в 98,8 и 100,0 % случаев соответственно. Фиксированная комбинация левофлоксацина и кеторолака хорошо переносилась, не оказывая негативного воздействия на глазную поверхность. Заключение. Применение Сигницеф® Плюс в течение 5 дней и Флоас Моно на протяжении 2 нед является эффективным и безопасным инструментом профилактики инфекционных и воспалительных осложнений ФЭК.

Purpose. To develop an algorithm for efficient and safe application of the fixed combination of levofloxacin and ketorolac (Signicef® Plus) for the prevention of infectious complications and excessive inflammatory response after phacoemulsification (PE). Materials and methods. The studу group consisted of 449 patients (500 eyes), examined on 6th and 15th day after uncomplicated PE of senile cataract. Prevention of infection and inflammation included instillations of Signicef® Plus QID over five days and 0.1 % solution of fluorometholone (Floace Mono) QID for two weeks since the day of the operation. Primary outcome — proportion of patients with zero inflammatory response in the anterior segment, secondary outcomes — incidence of acute endophthalmitis, ocular surface condition and tolerance of the fixed combination. Results. Among the studied patients there were no cases of acute iridocyclitis or endophthalmitis. No inflammatory response on the 6th and the 15th day was reported in 98.8 and 100 % of cases respectively. The fixed combination was well tolerated without having a negative effect on the ocular surface. Conclusions. The use of Signicef® Plus for five days and Floace Mono for two weeks appears to be an effective and safe tool for preventing infectious and inflammatory complications of PE.

катарактафакоэмульсификацияпослеоперационный осмотрлевофлоксацинфторметолонкеторолакcataractphacoemulsificationpostoperative examinationlevofloxacinfluorometholoneketorolacReferencesАстахов Ю.С., Николаенко В.П. Офтальмология. Фармакотерапия без ошибок. Москва: Е-ното, 2021.Astakhov Yu.S., Nikolaenko V.P. Ophthalmology. Pharmacotherapy without mistakes. Moscow: E-noto. 2021 (In Russ.).el-Harazi SM, Ruiz RS, Feldman RM, Villanueva G, Chuang AZ. A randomized double-masked trial comparing ketorolac tromethamine 0.5 %, diclofenac sodium 0.1 %, and prednisolone acetate 1 % in reducing post-phacoemulsification flare and cells. Ophthalmic Surg Lasers. 1998 Jul; 29 (7): 539–44. PMID: 9674003.el-Harazi SM, Ruiz RS, Feldman RM, Villanueva G, Chuang AZ. A randomized double-masked trial comparing ketorolac tromethamine 0.5 %, diclofenac sodium 0.1 %, and prednisolone acetate 1 % in reducing post-phacoemulsification flare and cells. Ophthalmic Surg Lasers. 1998 Jul; 29 (7): 539–44. PMID: 9674003.Valotis A, Neukam K, Elert O, Högger P. Human receptor kinetics, tissue binding affinity, and stability of mometasone furoate. J Pharm Sci. 2004 May; 93 (5): 1337–50. doi: 10.1002/jps.20049Valotis A, Neukam K, Elert O, Högger P. Human receptor kinetics, tissue binding affinity, and stability of mometasone furoate. J Pharm Sci. 2004 May; 93 (5): 1337–50. doi: 10.1002/jps.20049Pleyer U, Ursell PG, Rama P. Intraocular pressure effects of common topical steroids for post-cataract inflammation: are they all the same? Ophthalmol Ther. 2013 Dec; 2 (2): 55–72. doi: 10.1007/s40123-013-0020-5Pleyer U, Ursell PG, Rama P. Intraocular pressure effects of common topical steroids for post-cataract inflammation: are they all the same? Ophthalmol Ther. 2013 Dec; 2 (2): 55–72. doi: 10.1007/s40123-013-0020-5Петров С.Ю., Антонов А.А., Макарова А.С. и др. Возможности пролонгации гипотензивного эффекта трабекулэктомии. Вестник офтальмологии. 2015; 131 (1): 75–81. doi: 10.17116/oftalma2015131175-81Petrov S.Yu., Antonov A.A., Makarova А.S., et al. Options for prolonging the hypotensive effect of trabeculectomy. Vestnik oftal’mologii. 2015; 131 (1): 75–81 (In Russ.). doi: 10.17116/oftalma2015131175-81Trinavarat A, Atchaneeyasakul LO, Surachatkumtonekul T, Kosrirukvongs P. Comparison of topical prednisolone acetate, ketorolac tromethamine and fluorometholone acetate in reducing inflammation after phacoemulsification. J Med Assoc Thai. 2003 Feb; 86 (2): 143–50. PMID: 12678152.Trinavarat A, Atchaneeyasakul LO, Surachatkumtonekul T, Kosrirukvongs P. Comparison of topical prednisolone acetate, ketorolac tromethamine and fluorometholone acetate in reducing inflammation after phacoemulsification. J Med Assoc Thai. 2003 Feb; 86 (2): 143–50. PMID: 12678152.Bucci FA Jr, Waterbury LD. Prostaglandin E2 inhibition of ketorolac 0.45%, bromfenac 0.09%, and nepafenac 0.1% in patients undergoing phacoemulsification. Adv Ther. 2011 Dec; 28 (12): 1089–95. doi: 10.1007/s12325-011-0080-7Bucci FA Jr, Waterbury LD. Prostaglandin E2 inhibition of ketorolac 0.45%, bromfenac 0.09%, and nepafenac 0.1% in patients undergoing phacoemulsification. Adv Ther. 2011 Dec; 28 (12): 1089–95. doi: 10.1007/s12325-011-0080-7Porela-Tiihonen S, Kaarniranta K, Kokki H. Postoperative pain after cataract surgery. J Cataract Refract Surg. 2013 May; 39 (5): 789–98. doi: 10.1016/j.jcrs.2013.03.012Porela-Tiihonen S, Kaarniranta K, Kokki H. Postoperative pain after cataract surgery. J Cataract Refract Surg. 2013 May; 39 (5): 789–98. doi: 10.1016/j.jcrs.2013.03.012Price MO, Price FW. Efficacy of topical ketorolac tromethamine 0.4 % for control of pain or discomfort associated with cataract surgery. Curr Med Res Opin. 2004 Dec; 20 (12): 2015–9. doi: 10.1185/030079904x16759Price MO, Price FW. Efficacy of topical ketorolac tromethamine 0.4 % for control of pain or discomfort associated with cataract surgery. Curr Med Res Opin. 2004 Dec; 20 (12): 2015–9. doi: 10.1185/030079904x16759Буратто Л. Хирургия катаракты. Переход от экстракапсулярной экстракции катаракты к факоэмульсификации. Издательство: Fabiano Editore; 1999.Buratto L. Cataract surgery: Transition from extracapsular cataract extraction to phacoemulsification. Publisher: Fabiano Editore; 1999 (In Russ.).Chylack LT Jr, Wolfe JK, Singer DM, et al. The Lens Opacities Classification System III. The longitudinal study of cataract study group. Arch Ophthalmol. 1993 Jun; 111 (6): 831–6. doi: 10.1001/archopht.1993.01090060119035Chylack LT Jr, Wolfe JK, Singer DM, et al. The Lens Opacities Classification System III. The longitudinal study of cataract study group. Arch Ophthalmol. 1993 Jun; 111 (6): 831–6. doi: 10.1001/archopht.1993.01090060119035Клинические рекомендации «Катаракта старческая», 2024. (Электронный ресурс). Дата обращения: 19.01.2025 Available at: http://avo-portal.ru/doc/fkr/re-discussion/item/467-katarakta-starcheskaya.Clinical guidelines “Senile cataract”, 2024. (Electronic resource). (In Russ.). Available at: http://avo-portal.ru/doc/fkr/re-discussion/item/467-katarakta-starcheskaya. Access date: 19.01.2025Faraldi F, Papa V, Rasà D et al. Netilmicin/dexamethasone fixed combination in the treatment of conjunctival inflammation. Clin Ophthalmol. 2013; 7: 1239–44. doi: 10.2147/OPTH.S44455Faraldi F, Papa V, Rasà D et al. Netilmicin/dexamethasone fixed combination in the treatment of conjunctival inflammation. Clin Ophthalmol. 2013; 7: 1239–44. doi: 10.2147/OPTH.S44455Jabs DA, Nussenblatt RB, Rosenbaum JT. Standardization of uveitis nomenclature (SUN) Working Group. Standardization of uveitis nomenclature for reporting clinical data. Results of the First International Workshop. Am J Ophthalmol. 2005 Sep; 140 (3): 509–16. doi: 10.1016/j.ajo.2005.03.057Jabs DA, Nussenblatt RB, Rosenbaum JT. Standardization of uveitis nomenclature (SUN) Working Group. Standardization of uveitis nomenclature for reporting clinical data. Results of the First International Workshop. Am J Ophthalmol. 2005 Sep; 140 (3): 509–16. doi: 10.1016/j.ajo.2005.03.057Николаенко В.П., Белов Д.Ф. Клинические особенности и лечение эндофтальмита после хирургии катаракты. Вестник офтальмологии. 2023; 139 (2): 52–60. doi: 10.17116/oftalma202313902153Nikolaenko V.P., Belov D.F. Clinical features and treatment of endophthalmitis after cataract surgery. Vestnik oftal’mologii. 2023; 139 (2): 52–60 (In Russ.). doi: 10.17116/oftalma202313902153Morgan PB, Maldonado-Codina C. Corneal staining: do we really understand what we are seeing? Cont Lens Anterior Eye. 2009 Apr; 32 (2): 48–54. doi: 10.1016/j.clae.2008.09.004Morgan PB, Maldonado-Codina C. Corneal staining: do we really understand what we are seeing? Cont Lens Anterior Eye. 2009 Apr; 32 (2): 48–54. doi: 10.1016/j.clae.2008.09.004Whitcher JP, Shiboski CH, Shiboski SC, et al. Sjögren’s International Collaborative Clinical Alliance Research Groups. A simplified quantitative method for assessing keratoconjunctivitis sicca from the Sjögren’s Syndrome International Registry. Am J Ophthalmol. 2010 Mar; 149 (3): 405–15. doi: 10.1016/j.ajo.2009.09.013Whitcher JP, Shiboski CH, Shiboski SC, et al. Sjögren’s International Collaborative Clinical Alliance Research Groups. A simplified quantitative method for assessing keratoconjunctivitis sicca from the Sjögren’s Syndrome International Registry. Am J Ophthalmol. 2010 Mar; 149 (3): 405–15. doi: 10.1016/j.ajo.2009.09.013Bron AJ, Evans VE, Smith JA. Grading of corneal and conjunctival staining in the context of other dry eye tests. Cornea. 2003 Oct; 22 (7): 640–50. doi: 10.1097/00003226-200310000-00008Bron AJ, Evans VE, Smith JA. Grading of corneal and conjunctival staining in the context of other dry eye tests. Cornea. 2003 Oct; 22 (7): 640–50. doi: 10.1097/00003226-200310000-00008Bodaghi B, Weber ME, Arnoux YV, et al. Comparison of the efficacy and safety of two formulations of diclofenac sodium 0.1 % eyedrops in controlling postoperative inflammation after cataract surgery. Eur J Ophthalmol. 2005 Nov-Dec; 15 (6): 702–11. doi: 10.1177/112067210501500608Bodaghi B, Weber ME, Arnoux YV, et al. Comparison of the efficacy and safety of two formulations of diclofenac sodium 0.1 % eyedrops in controlling postoperative inflammation after cataract surgery. Eur J Ophthalmol. 2005 Nov-Dec; 15 (6): 702–11. doi: 10.1177/112067210501500608Barry P, Behrens-Baumann W, Pleyer U, Seal D. ESCRS Guidelines on prevention, investigation and management of postoperative endophthalmitis. Version 2, 14. 2007; (Electronic resource). Available from: https://www.researchgate.net/publication/265099077_ESCRS_Guidelines_on_prevpreven_investigation_and_management_of_post-operative_endophthalmitis (access date: 19.01.2025)Barry P, Behrens-Baumann W, Pleyer U, Seal D. ESCRS Guidelines on prevention, investigation and management of postoperative endophthalmitis. Version 2, 14. 2007; (Electronic resource). Available from: https://www.researchgate.net/publication/265099077_ESCRS_Guidelines_on_prevpreven_investigation_and_management_of_post-operative_endophthalmitis (access date: 19.01.2025)Barry P, Cordovés L, Gardner S. ESCRS guidelines for prevention and treatment of endophthalmitis following cataract surgery: data, dilemmas and conclusion. 2013; 44. (Electronic resource). Available from: https://www.escrs.org/media/uljgvpn1/english_2018_updated.pdf (access date: 19.01.2025)Barry P, Cordovés L, Gardner S. ESCRS guidelines for prevention and treatment of endophthalmitis following cataract surgery: data, dilemmas and conclusion. 2013; 44. (Electronic resource). Available from: https://www.escrs.org/media/uljgvpn1/english_2018_updated.pdf (access date: 19.01.2025)Aptel F, Colin C, Kaderli S, et al; OSIRIS group. Management of postoperative inflammation after cataract and complex ocular surgeries: a systematic review and Delphi survey. Br J Ophthalmol. 2017 Nov; 101 (11): 1–10. doi: 10.1136/bjophthalmol-2017-310324Aptel F, Colin C, Kaderli S, et al; OSIRIS group. Management of postoperative inflammation after cataract and complex ocular surgeries: a systematic review and Delphi survey. Br J Ophthalmol. 2017 Nov; 101 (11): 1–10. doi: 10.1136/bjophthalmol-2017-310324Николаенко В.П., Белов Д.Ф. Антибиотикопрофилактика острого послеоперационного эндофтальмита. Клиническая офтальмология. 2021; 21 (4): 220–6. doi: 10.32364/2311-7729-2021-21-4-220-226Nikolaenko V.P., Belov D.F. Antibiotic prophylaxis of acute postoperative endophthalmitis. Russian journal of clinical ophthalmology. 2021; 21 (4): 220–6 (In Russ.). doi: 10.32364/2311-7729-2021-21-4-220-226Пирогов Ю.И., Шустрова Т.А., Обловацкая Е.С., Хромова Е.С. Влияние периоперационной антибактериальной профилактики с помощью глазных капель на основе фторхинолонов на микрофлору конъюнктивы у пациентов до и после факоэмульсификации. Офтальмология. 2020; 17 (1): 111–6. doi: 10.18008/1816-5095-2020-1-111-116Pirogov Yu.I., Shustrova T.A., Oblovatskayа E.S., Khrоmova Е.S. Effect of perioperative antibacterial prophylaxis using eye drops with fluoroquinolones on conjunctival microflora in patients before and after phacoemulsification. Ophthalmology in Russia. 2020; 17 (1): 111–6 (In Russ.). doi: 10.18008/1816-5095-2020-1-111-116Bandello F, Coassin M, Zazzo A, Carnovali M, et al. One week of levofloxacin plus dexamethasone eye drops for cataract surgery: an innovative and rational therapeutic strategy. Eye (Lond). 2020 Nov; 34 (11): 2112–22. doi: 10.1038/s41433-020-0869-1Bandello F, Coassin M, Zazzo A, Carnovali M, et al. One week of levofloxacin plus dexamethasone eye drops for cataract surgery: an innovative and rational therapeutic strategy. Eye (Lond). 2020 Nov; 34 (11): 2112–22. doi: 10.1038/s41433-020-0869-1Потемкин В.В., Агеева Е.В. Нестабильность связочного аппарата хрусталика у пациентов с псевдоэксфолиативным синдромом: анализ 1000 последовательных факоэмульсификаций. Офтальмологические ведомости. 2018; 11 (1): 41–6. doi: 10.17816/OV11141-46Potyomkin V.V., Ageeva E.V. Zonular instability in patients with pseudoexfoliative syndrome: the analysis of 1000 consecutive phacoemulsifications. Ophthalmology reports. 2018; 11 (1): 41–6 (In Russ.). doi: 10.17816/OV11141-46Olson RJ, Braga-Mele R, Chen SH, et al. Cataract in the adult eye preferred practice Pattern®. Ophthalmology. 2017 Feb; 124 (2): P1-P119. doi: 10.1016/j.ophtha.2016.09.027Olson RJ, Braga-Mele R, Chen SH, et al. Cataract in the adult eye preferred practice Pattern®. Ophthalmology. 2017 Feb; 124 (2): P1-P119. doi: 10.1016/j.ophtha.2016.09.027Grzybowski A, Kanclerz P. Do we need day-1 postoperative follow-up after cataract surgery? Graefes Arch Clin Exp Ophthalmol. 2019 May; 257 (5): 855–61. doi: 10.1007/s00417-018-04210-0Grzybowski A, Kanclerz P. Do we need day-1 postoperative follow-up after cataract surgery? Graefes Arch Clin Exp Ophthalmol. 2019 May; 257 (5): 855–61. doi: 10.1007/s00417-018-04210-0Borkar DS, Laíns I, Eton EA, et al; Perioperative Care for IntraOcular Lens Study Group. Incidence of management changes at the postoperative week 1 visit after cataract surgery: results from the perioperative care for IntraOcular Lens Study. Am J Ophthalmol. 2019 Mar; 199: 94–100. doi: 10.1016/j.ajo.2018.10.013Borkar DS, Laíns I, Eton EA, et al; Perioperative Care for IntraOcular Lens Study Group. Incidence of management changes at the postoperative week 1 visit after cataract surgery: results from the perioperative care for IntraOcular Lens Study. Am J Ophthalmol. 2019 Mar; 199: 94–100. doi: 10.1016/j.ajo.2018.10.013Westborg I, Mönestam E. Optimizing number of postoperative visits after cataract surgery: Safety perspective. J Cataract Refract Surg. 2017 Sep; 43 (9): 1184–9. doi: 10.1016/j.jcrs.2017.06.042Westborg I, Mönestam E. Optimizing number of postoperative visits after cataract surgery: Safety perspective. J Cataract Refract Surg. 2017 Sep; 43 (9): 1184–9. doi: 10.1016/j.jcrs.2017.06.042Николаенко В.П., Белов Д.Ф., Антонова А.В. Хирургия катаракты: рациональный алгоритм послеоперационных осмотров пациентов. Офтальмологические ведомости. 2024; 17 (4): 125–32. doi: 10.17816/OV635529Nikolaenko V.P., Belov D.F., Аntonova A.V. Cataract surgery: rational algorithm of postoperative examination of patients. Ophthalmology reports. 2024; 17 (4): 125–32 (In Russ.). doi: 10.17816/OV635529

The authors declare that there are no conflicts of interest present.