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.
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Change history
09 February 2021
A Correction to this paper has been published: https://doi.org/10.1038/s41433-020-0987-9
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Acknowledgements
We would thank OPIS (Desio, Italy), the CRO for the trial, for the fruitful and skilful assistance in managing and analyzing the data.
LEADER-7 Investigators
Pasquale Aragona11, Paolo Arvedi12, Carlo Cagini13, Luigi Caretti14, Gian Maria Cavallini15, Salvatore Cillino16, Innocente Figini17, Livio Marco Franco18, Alberto La Mantia19, Antonio Laborante20, Paolo Lanzetta21, Mattia Marcigaglia22, Cesare Mariotti23, Enrico Martini24, Leonardo Mastropasqua25, Simonetta Morselli26, Franco Passani27, Alfredo Pece28, Grazia Pertile29, Antonino Pioppo30, Cesare Pirondini31, Marcello Prantera32, Antonio Rapisarda33, Mario R. Romano34, Giuseppe Scarpa35, Domenico Schiano-Lomoriello36, Vincenzo Scorcia37, Gianluca Scuderi38, Francesco Semeraro39, Franco Spedale40, Giovanni Staurenghi41, Daniele Tognetto42, Marco Tosi43, Giuseppe Trabucchi44, Fausto Trivella45, Edoardo Villani46, Andrea Vento47, Paolo Vinciguerra48, Jorge L. Alió49, Josè F. Alfonso Sanchez50, Francisco Arnalich Montiel51, Katrin Lorenz52, Irina Panova53, Alena Eremina54, Giorgio Ciprandi55
Funding
NTC Milan, Italy, sponsored the study.
Role of the funding source
The study sponsor had the following role in: study design, data collection, analysis, interpretation of data, writing of the report and decision to submit the paper for publication.
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FB reports grants from NTC srl, Allergan, Fidia-SOOFT, Novartis, Sifi; TK reports grants from Allergan, Avedro, Bausch & Lomb, Carl Zeiss, Dompé, Geuder, Hoya, Johnson & Johnson, Med Update, Merck, Novartis/Alcon, Oculentis, Oculus, Presbia, Rayner, Santen, Schwind, Staar, Tear Lab, Thea, Thieme, Zeiss, Ziemer; BM reports grant from NTC srl. All other authors declare no competing interests.
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Bandello, F., Coassin, M., Di Zazzo, A. et al. One week of levofloxacin plus dexamethasone eye drops for cataract surgery: an innovative and rational therapeutic strategy. Eye 34, 2112–2122 (2020). https://doi.org/10.1038/s41433-020-0869-1
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DOI: https://doi.org/10.1038/s41433-020-0869-1
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