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

Authors :
A. Pioppo
P. De Rosa
G. Scuderi
Teresio Avitabile
G. Pertile
D. Schiano-Lomoriello
Vincenza Bonfiglio
F. Passani
G. Staurenghi
S. Morselli
Paolo Vinciguerra
F. Fasce
G. Trabucchi
Salvatore Cillino
F. A. Montiel
V. Scorcia
L. Mastropasqua
D. Tognetto
A. Laborante
Mary Romano
A. La Mantia
A. Rapisarda
E. Martini
M. Coassin
C. Mariotti
F. Spedale
C. Pirondini
P. Arvedi
I. Panova
A. Vento
Stanislao Rizzo
J. L. Mateu
M. Sinitsyn
L. M. Franco
A. Eremina
P. Aragona
G. Ciprandi
Carlo Cagini
F. Calabro
Alfredo Pece
M. Marcigaglia
B. Malyugin
I. Figini
Gian Maria Cavallini
Maria Chiara Tosi
M. Prantera
L. Caretti
I. Biagini
A. Di Zazzo
J. F. Alfonso Sanchez
J. L. Alio
T. Kohnen
M. Carnovali
K. Lorenz
Francesco Semeraro
E. Villani
Paolo Lanzetta
G. Scarpa
Francesco Bandello
R. Barraquer
A. Verzin
F. Trivella
N. Pozdeyeva
Bandello, Francesco
Coassin, Marco
Di Zazzo, Antonio
Rizzo, Stanislao
Biagini, Ilaria
Pozdeyeva, Nadezhda
Sinitsyn, Maksim
Verzin, Alexander
De Rosa, Pasquale
Calabrò, Francesco
Avitabile, Teresio
Bonfiglio, Vincenza
Fasce, Francesco
Barraquer, Rafael
Mateu, Josè Lamarca
Kohnen, Thoma
Carnovali, Marino
Malyugin, Boris
Source :
Eye (Lond)
Publication Year :
2020

Abstract

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.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.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.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.

Details

Database :
OpenAIRE
Journal :
Eye (Lond)
Accession number :
edsair.doi.dedup.....247dcf80927c1ca3a1abf597fad972ab