Background: Cataract surgery is the most common operation performed worldwide. A fixed topical corticosteroid-antibiotic combination is usually prescribed in clinical practice for 2 or more weeks to treat post surgical inflammation and prevent infection. However, this protracted schedule may increase the incidence of corticosteroid-related adverse events and notably promote antibiotic resistance. Methods: This International, multicentre, randomized, blinded-assessor, parallel-group clinical study evaluated the non-inferiority of 1-week levofloxacin/dexamethasone eye drops, followed by 1-week dexamethasone alone, vs. 2-week gold-standard tobramycin/dexamethasone (one drop QID for all schedules) to prevent and treat ocular inflammation and prevent infection after uncomplicated cataract surgery. Non-inferiority was defined as the lower limit of the 95% confidence interval (CI) around a treatment difference >–10%. The study randomized 808 patients enrolled in 53 centres (Italy, Germany, Spain and Russia). The primary endpoint was the proportion of patients without anterior chamber inflammation on day 15 defined as the end of treatment. Endophthalmitis was the key secondary endpoint. This study is registered with EudraCT code: 2018-000286-36. Results: After the end of treatment, 95.2% of the patients in the test arm vs. 94.9% of the control arm had no signs of inflammation in the anterior chamber (difference between proportions of patients = 0.028; 95% CI: −0.0275/0.0331). No case of endophthalmitis was reported. No statistically significant difference was evident in any of the other secondary endpoints. Both treatments were well tolerated. Conclusions: Non-inferiority of the new short pharmacological strategy was proven. One week of levofloxacin/dexamethasone prevents infection, ensures complete control of inflammation in almost all patients and may contain antibiotic resistance.

One week of levofloxacin plus dexamethasone eye drops for cataract surgery: an innovative and rational therapeutic strategy / Bandello, F.; Coassin, M.; Di Zazzo, A.; Rizzo, S.; Biagini, I.; Pozdeyeva, N.; Sinitsyn, M.; Verzin, A.; De Rosa, P.; Calabro, F.; Avitabile, T.; Bonfiglio, V.; Fasce, F.; Barraquer, R.; Mateu, J. L.; Khonen, T.; Carnovali, M.; Malyugin, B.; Aragona, P.; Arvedi, P.; Cagini, C.; Caretti, L.; Cavallini, G. M.; Cillino, S.; Figini, I.; Franco, L. M.; La Mantia, A.; Laborante, A.; Lanzetta, P.; Marcigaglia, M.; Mariotti, C.; Martini, E.; Mastropasqua, L.; Morselli, S.; Passani, F.; Pece, A.; Pertile, G.; Pioppo, A.; Pirondini, C.; Prantera, M.; Rapisarda, A.; Romano, M. R.; Scarpa, G.; Schiano-Lomoriello, D.; Scorcia, V.; Scuderi, G.; Semeraro, F.; Spedale, F.; Staurenghi, G.; Tognetto, D.; Tosi, M.; Trabucchi, G.; Trivella, F.; Villani, E.; Vento, A.; Vinciguerra, P.; Alio, J. L.; Alfonso Sanchez, J. F.; Montiel, F. A.; Lorenz, K.; Panova, I.; Eremina, A.; Ciprandi, G.. - In: EYE. - ISSN 0950-222X. - (2020), pp. 1-11. [10.1038/s41433-020-0869-1]

One week of levofloxacin plus dexamethasone eye drops for cataract surgery: an innovative and rational therapeutic strategy

De Rosa P.;Cavallini G. M.;Martini E.;Trabucchi G.;
2020

Abstract

Background: Cataract surgery is the most common operation performed worldwide. A fixed topical corticosteroid-antibiotic combination is usually prescribed in clinical practice for 2 or more weeks to treat post surgical inflammation and prevent infection. However, this protracted schedule may increase the incidence of corticosteroid-related adverse events and notably promote antibiotic resistance. Methods: This International, multicentre, randomized, blinded-assessor, parallel-group clinical study evaluated the non-inferiority of 1-week levofloxacin/dexamethasone eye drops, followed by 1-week dexamethasone alone, vs. 2-week gold-standard tobramycin/dexamethasone (one drop QID for all schedules) to prevent and treat ocular inflammation and prevent infection after uncomplicated cataract surgery. Non-inferiority was defined as the lower limit of the 95% confidence interval (CI) around a treatment difference >–10%. The study randomized 808 patients enrolled in 53 centres (Italy, Germany, Spain and Russia). The primary endpoint was the proportion of patients without anterior chamber inflammation on day 15 defined as the end of treatment. Endophthalmitis was the key secondary endpoint. This study is registered with EudraCT code: 2018-000286-36. Results: After the end of treatment, 95.2% of the patients in the test arm vs. 94.9% of the control arm had no signs of inflammation in the anterior chamber (difference between proportions of patients = 0.028; 95% CI: −0.0275/0.0331). No case of endophthalmitis was reported. No statistically significant difference was evident in any of the other secondary endpoints. Both treatments were well tolerated. Conclusions: Non-inferiority of the new short pharmacological strategy was proven. One week of levofloxacin/dexamethasone prevents infection, ensures complete control of inflammation in almost all patients and may contain antibiotic resistance.
2020
EYE
1
11
One week of levofloxacin plus dexamethasone eye drops for cataract surgery: an innovative and rational therapeutic strategy / Bandello, F.; Coassin, M.; Di Zazzo, A.; Rizzo, S.; Biagini, I.; Pozdeyeva, N.; Sinitsyn, M.; Verzin, A.; De Rosa, P.; Calabro, F.; Avitabile, T.; Bonfiglio, V.; Fasce, F.; Barraquer, R.; Mateu, J. L.; Khonen, T.; Carnovali, M.; Malyugin, B.; Aragona, P.; Arvedi, P.; Cagini, C.; Caretti, L.; Cavallini, G. M.; Cillino, S.; Figini, I.; Franco, L. M.; La Mantia, A.; Laborante, A.; Lanzetta, P.; Marcigaglia, M.; Mariotti, C.; Martini, E.; Mastropasqua, L.; Morselli, S.; Passani, F.; Pece, A.; Pertile, G.; Pioppo, A.; Pirondini, C.; Prantera, M.; Rapisarda, A.; Romano, M. R.; Scarpa, G.; Schiano-Lomoriello, D.; Scorcia, V.; Scuderi, G.; Semeraro, F.; Spedale, F.; Staurenghi, G.; Tognetto, D.; Tosi, M.; Trabucchi, G.; Trivella, F.; Villani, E.; Vento, A.; Vinciguerra, P.; Alio, J. L.; Alfonso Sanchez, J. F.; Montiel, F. A.; Lorenz, K.; Panova, I.; Eremina, A.; Ciprandi, G.. - In: EYE. - ISSN 0950-222X. - (2020), pp. 1-11. [10.1038/s41433-020-0869-1]
Bandello, F.; Coassin, M.; Di Zazzo, A.; Rizzo, S.; Biagini, I.; Pozdeyeva, N.; Sinitsyn, M.; Verzin, A.; De Rosa, P.; Calabro, F.; Avitabile, T.; Bonfiglio, V.; Fasce, F.; Barraquer, R.; Mateu, J. L.; Khonen, T.; Carnovali, M.; Malyugin, B.; Aragona, P.; Arvedi, P.; Cagini, C.; Caretti, L.; Cavallini, G. M.; Cillino, S.; Figini, I.; Franco, L. M.; La Mantia, A.; Laborante, A.; Lanzetta, P.; Marcigaglia, M.; Mariotti, C.; Martini, E.; Mastropasqua, L.; Morselli, S.; Passani, F.; Pece, A.; Pertile, G.; Pioppo, A.; Pirondini, C.; Prantera, M.; Rapisarda, A.; Romano, M. R.; Scarpa, G.; Schiano-Lomoriello, D.; Scorcia, V.; Scuderi, G.; Semeraro, F.; Spedale, F.; Staurenghi, G.; Tognetto, D.; Tosi, M.; Trabucchi, G.; Trivella, F.; Villani, E.; Vento, A.; Vinciguerra, P.; Alio, J. L.; Alfonso Sanchez, J. F.; Montiel, F. A.; Lorenz, K.; Panova, I.; Eremina, A.; Ciprandi, G.
File in questo prodotto:
File Dimensione Formato  
s41433-020-0869-1.pdf

Accesso riservato

Tipologia: Versione pubblicata dall'editore
Dimensione 917.45 kB
Formato Adobe PDF
917.45 kB Adobe PDF   Visualizza/Apri   Richiedi una copia
Pubblicazioni consigliate

Licenza Creative Commons
I metadati presenti in IRIS UNIMORE sono rilasciati con licenza Creative Commons CC0 1.0 Universal, mentre i file delle pubblicazioni sono rilasciati con licenza Attribuzione 4.0 Internazionale (CC BY 4.0), salvo diversa indicazione.
In caso di violazione di copyright, contattare Supporto Iris

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11380/1208889
Citazioni
  • ???jsp.display-item.citation.pmc??? 9
  • Scopus 20
  • ???jsp.display-item.citation.isi??? 18
social impact