First experience with a fixed combination of levofloxacin and ketorolac in cataract surgery
https://doi.org/10.21516/2072-0076-2025-18-1-48-54
Abstract
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.
About the Authors
V. P. NikolaenkoRussian Federation
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
D. F. Belov
Russian Federation
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
References
1. Astakhov Yu.S., Nikolaenko V.P. Ophthalmology. Pharmacotherapy without mistakes. Moscow: E-noto. 2021 (In Russ.).
2. 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.
3. 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.20049
4. Pleyer 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/s40123-013-0020-5
5. Petrov 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/oftalma2015131175-81
6. 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.
7. 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/s12325-011-0080-7
8. Porela-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.2013.03.012
9. Price 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: 10.1185/030079904x16759
10. Buratto L. Cataract surgery: Transition from extracapsular cataract extraction to phacoemulsification. Publisher: Fabiano Editore; 1999 (In Russ.).
11. 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.1993.01090060119035
12. 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: 19.01.2025
13. Faraldi 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.S44455
14. Jabs 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.2005.03.057
15. Nikolaenko 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/oftalma202313902153
16. Morgan 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.2008.09.004
17. Whitcher 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.2009.09.013
18. Bron 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: 10.1097/00003226-200310000-00008
19. Bodaghi 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: 10.1177/112067210501500608
20. 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)
21. 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)
22. 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-2017-310324
23. Nikolaenko V.P., Belov D.F. Antibiotic prophylaxis of acute postoperative endophthalmitis. Russian journal of clinical ophthalmology. 2021; 21 (4): 220–6 (In Russ.). doi: 10.32364/2311-7729-2021-21-4-220-226
24. Pirogov 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: 10.18008/1816-5095-2020-1-111-116
25. Bandello 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/s41433-020-0869-1
26. Potyomkin 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/OV11141-46
27. Olson 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.2016.09.027
28. Grzybowski 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/s00417-018-04210-0
29. Borkar 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.2018.10.013
30. Westborg 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.2017.06.042
31. Nikolaenko 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
Review
For citations:
Nikolaenko V.P., Belov D.F. First experience with a fixed combination of levofloxacin and ketorolac in cataract surgery. Russian Ophthalmological Journal. 2025;18(1):48-54. (In Russ.) https://doi.org/10.21516/2072-0076-2025-18-1-48-54