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1. Correction: One week of levofloxacin plus dexamethasone eye drops for cataract surgery: an innovative and rational therapeutic strategy (Eye, (2020), 34, 11, (2112-2122), 10.1038/s41433-020-0869-1)

Author

Bandello, F., Coassin, M., Di Zazzo, A., Rizzo, Stanislao, Biagini, Ilaria, Pozdeyeva, N., Sinitsyn, M., Verzin, A., De Rosa, P., Calabro, F., Avitabile, T., Bonfiglio, V., Fasce, F., Barraquer, R., Mateu, J. L., Kohnen, 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, Cesare, 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., Rizzo S. (ORCID:0000-0001-6302-063X), Biagini I., Mariotti C., Bandello, F., Coassin, M., Di Zazzo, A., Rizzo, Stanislao, Biagini, Ilaria, Pozdeyeva, N., Sinitsyn, M., Verzin, A., De Rosa, P., Calabro, F., Avitabile, T., Bonfiglio, V., Fasce, F., Barraquer, R., Mateu, J. L., Kohnen, 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, Cesare, 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., Rizzo S. (ORCID:0000-0001-6302-063X), Biagini I., and Mariotti C.

Abstract

An amendment to this paper has been published and can be accessed via a link at the top of the paper.

Published
2020

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

Author

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, Thomas, Carnovali, Marino, Malyugin, Boris, Pasquale, Aragona, Paolo, Arvedi, Carlo, Cagini, Luigi, Caretti, Gian Maria Cavallini, Salvatore, Cillino, Innocente, Figini, Livio Marco Franco, Alberto La Mantia, Antonio, Laborante, Paolo, Lanzetta, Mattia, Marcigaglia, Cesare, Mariotti, Enrico, Martini, Leonardo, Mastropasqua, Simonetta, Morselli, Franco, Passani, Alfredo, Pece, Grazia, Pertile, Antonino, Pioppo, Cesare, Pirondini, Marcello, Prantera, Antonio, Rapisarda, Romano, Mario R., Giuseppe, Scarpa, Domenico, Schiano-Lomoriello, Vincenzo, Scorcia, Gianluca, Scuderi, Francesco, Semeraro, Franco, Spedale, Giovanni, Staurenghi, Tognetto, Daniele, Marco, Tosi, Giuseppe, Trabucchi, Fausto, Trivella, Edoardo, Villani, Andrea, Vento, Paolo, Vinciguerra, Alió, Jorge L., Alfonso Sanchez, Josè F., Francisco Arnalich Montiel, Katrin, Lorenz, Irina, Panova, Alena, Eremina, Giorgio, Ciprandi, 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., Kohnen 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., Francesco, Bandello, Marco, Coassin, Antonio, Di Zazzo, Stanislao, Rizzo, Ilaria, Biagini, Nadezhda, Pozdeyeva, Maksim, Sinitsyn, Alexander, Verzin, Pasquale, De Rosa, Francesco, Calabrò, Teresio, Avitabile, Vincenza, Bonfiglio, Francesco, Fasce, Rafael, Barraquer, Josè Lamarca, Mateu, Thomas, Kohnen, Marino, Carnovali, Boris, Malyugin, Aragona, Pasquale, Arvedi, Paolo, Cagini, Carlo, Caretti, Luigi, Maria Cavallini, Gian, Cillino, Salvatore, Figini, Innocente, Marco Franco, Livio, La Mantia, Alberto, Laborante, Antonio, Lanzetta, Paolo, Marcigaglia, Mattia, Mariotti, Cesare, Martini, Enrico, Mastropasqua, Leonardo, Morselli, Simonetta, Passani, Franco, Pece, Alfredo, Pertile, Grazia, Pioppo, Antonino, Pirondini, Cesare, Prantera, Marcello, Rapisarda, Antonio, Romano, Mario R., Scarpa, Giuseppe, Schiano-Lomoriello, Domenico, Scorcia, Vincenzo, Scuderi, Gianluca, Semeraro, Francesco, Spedale, Franco, Staurenghi, Giovanni, Tognetto, Daniele, Tosi, Marco, Trabucchi, Giuseppe, Trivella, Fausto, Villani, Edoardo, Vento, Andrea, Vinciguerra, Paolo, Alió, Jorge L., Alfonso Sanchez, Josè F., Arnalich Montiel, Francisco, Lorenz, Katrin, Panova, Irina, Eremina, Alena, Ciprandi, Giorgio, 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., Kohnen, 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., and Ciprandi, G.

Subjects
medicine.medical_specialty, medicine.medical_treatment, Levofloxacin, Article, Dexamethasone, Cataract, 03 medical and health sciences, 0302 clinical medicine, Endophthalmitis, Pharmacotherapy, Postoperative Complications, Internal medicine, medicine, Tobramycin, Clinical endpoint, Humans, Endophthalmitis, Cataract, Intracameral cefuroxime, Adverse effect, business.industry, Cataract surgery, Intracameral cefuroxime, medicine.disease, not applicable, Anti-Bacterial Agents, Ophthalmology, Italy, Spain, 030221 ophthalmology & optometry, Ophthalmic Solutions, business, 030217 neurology & neurosurgery, medicine.drug
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.

Published
2020

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