TY - JOUR
T1 - One week of levofloxacin plus dexamethasone eye drops for cataract surgery
T2 - an innovative and rational therapeutic strategy
AU - Group LEADER-7 Investigators
AU - Bandello, Francesco
AU - Coassin, Marco
AU - Di Zazzo, Antonio
AU - Rizzo, Stanislao
AU - Biagini, Ilaria
AU - Pozdeyeva, Nadezhda
AU - Sinitsyn, Maksim
AU - Verzin, Alexander
AU - De Rosa, Pasquale
AU - Calabrò, Francesco
AU - Avitabile, Teresio
AU - Bonfiglio, Vincenza
AU - Fasce, Francesco
AU - Barraquer, Rafael
AU - Mateu, Josè Lamarca
AU - Khonen, Thomas
AU - Carnovali, Marino
AU - Malyugin, Boris
AU - Aragona, Pasquale
AU - Arvedi, Paolo
AU - Cagini, Carlo
AU - Caretti, Luigi
AU - Cavallini, Gian Maria
AU - Cillino, Salvatore
AU - Figini, Innocente
AU - Franco, Livio Marco
AU - La Mantia, Alberto
AU - Laborante, Antonio
AU - Lanzetta, Paolo
AU - Marcigaglia, Mattia
AU - Mariotti, Cesare
AU - Martini, Enrico
AU - Mastropasqua, Leonardo
AU - Morselli, Simonetta
AU - Passani, Franco
AU - Pece, Alfredo
AU - Pertile, Grazia
AU - Pioppo, Antonino
AU - Pirondini, Cesare
AU - Prantera, Marcello
AU - Rapisarda, Antonio
AU - Romano, Mario R.
AU - Scarpa, Giuseppe
AU - Schiano-Lomoriello, Domenico
AU - Scorcia, Vincenzo
AU - Scuderi, Gianluca
AU - Semeraro, Francesco
AU - Spedale, Franco
AU - Villani, Edoardo
AU - Vinciguerra, Paolo
PY - 2020
Y1 - 2020
N2 - 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.
AB - 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.
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U2 - 10.1038/s41433-020-0869-1
DO - 10.1038/s41433-020-0869-1
M3 - Article
C2 - 32366996
AN - SCOPUS:85085099481
VL - 34
SP - 2112
EP - 2122
JO - Eye
JF - Eye
SN - 0950-222X
IS - 11
ER -