6533b7d8fe1ef96bd1269878
RESEARCH PRODUCT
One week of levofloxacin plus dexamethasone eye drops for cataract surgery: an innovative and rational therapeutic strategy
Francesco BandelloMarco CoassinAntonio Di ZazzoStanislao RizzoIlaria BiaginiNadezhda PozdeyevaMaksim SinitsynAlexander VerzinPasquale De RosaFrancesco CalabròTeresio AvitabileVincenza BonfiglioFrancesco FasceRafael BarraquerJosè Lamarca MateuThomas KohnenMarino CarnovaliBoris MalyuginAragona PasqualeArvedi PaoloCagini CarloCaretti Luigi Gian Maria CavalliniCillino SalvatoreFigini Innocente Livio Marco Franco Alberto La MantiaLaborante AntonioLanzetta PaoloMarcigaglia MattiaMariotti CesareMartini EnricoMastropasqua LeonardoMorselli SimonettaPassani FrancoPece AlfredoPertile GraziaPioppo AntoninoPirondini CesarePrantera MarcelloRapisarda AntonioMario R. RomanoScarpa GiuseppeSchiano-lomoriello DomenicoScorcia VincenzoScuderi GianlucaSemeraro FrancescoSpedale FrancoStaurenghi GiovanniDaniele TognettoTosi MarcoTrabucchi GiuseppeTrivella FaustoVillani EdoardoVento AndreaVinciguerra PaoloJorge L. AlióJosè F. Alfonso Sanchez Francisco Arnalich MontielLorenz KatrinPanova IrinaEremina AlenaCiprandi Giorgiosubject
medicine.medical_specialtymedicine.medical_treatmentLevofloxacinArticleDexamethasoneCataract03 medical and health sciences0302 clinical medicineEndophthalmitisPharmacotherapyPostoperative ComplicationsLevofloxacinInternal medicinemedicineTobramycinClinical endpointHumansEndophthalmitis Cataract Intracameral cefuroximeAdverse effectDexamethasoneEndophthalmitisbusiness.industryCataract surgeryIntracameral cefuroximemedicine.diseasenot applicableAnti-Bacterial AgentsOphthalmologyItalySpain030221 ophthalmology & optometryOphthalmic Solutionsbusiness030217 neurology & neurosurgerymedicine.drugdescription
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.
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2020-05-04 |