Journal of cataract and refractive surgery · 2021
Effectiveness of liposomal ozonized oil in reducing ocular microbial flora in patients undergoing cataract surgery.
Клиническое исследованиеСтатьяНазвание и аннотация: Перевод пока не подготовлен
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Spadea Leopoldo, Zanotto Elisa, Cavallo Rossana, Campagna Giuseppe, Giannico Maria Ilaria, Costagliola Ciro, ELOOM Study Investigators
Аннотация
PURPOSE: To evaluate the antimicrobial effectiveness of a liposomal ozonized oil solution used as a home therapy in patients undergoing cataract surgery. Antimicrobial efficacy was evaluated as the reduction in the bacterial load of the most common bacteria isolated from cases with endophthalmitis.
SETTING: 20 Italian experimental centers of the Effectiveness of Liposomal Ozonized oil on Ocular Microbial flora before cataract surgery study group.
DESIGN: Interventional, nonrandomized, paired-eye designed, phase 4 clinical study.
METHODS: A total of 174 patients undergoing cataract surgery were divided into 2 groups: the study group (174 eyes) underwent surgery and received an isotonic ophthalmic solution of 0.5% ozonized oil in liposomes plus hypromellose treatment (2 drops 4 times/d), and the control group (174 contralateral eyes) was treated with saline solution. The treatment lasted for 3 days. Subconjunctival swabs were taken from both eyes of each patient at T0 (the day before starting the treatment and 4 days preoperatively) and at T4 (after 3 days of treatment and 10 min preoperatively) and sent to the laboratory within 24 hours of collection for microbiological analysis.
RESULTS: 30% of 696 swabs taken at T0 were sterile. Contaminated swabs had a high prevalence of coagulase-negative staphylococci, including Staphylococcus epidermidis, and more than 60 different bacterial species were isolated. A significant reduction in microbial load was observed after treatment (>90% of the samples). The microbial load in the control group remained unchanged.
CONCLUSIONS: Liposomal ozonized oil reduced the microbial burden after topical administration in a large study population.
SETTING: 20 Italian experimental centers of the Effectiveness of Liposomal Ozonized oil on Ocular Microbial flora before cataract surgery study group.
DESIGN: Interventional, nonrandomized, paired-eye designed, phase 4 clinical study.
METHODS: A total of 174 patients undergoing cataract surgery were divided into 2 groups: the study group (174 eyes) underwent surgery and received an isotonic ophthalmic solution of 0.5% ozonized oil in liposomes plus hypromellose treatment (2 drops 4 times/d), and the control group (174 contralateral eyes) was treated with saline solution. The treatment lasted for 3 days. Subconjunctival swabs were taken from both eyes of each patient at T0 (the day before starting the treatment and 4 days preoperatively) and at T4 (after 3 days of treatment and 10 min preoperatively) and sent to the laboratory within 24 hours of collection for microbiological analysis.
RESULTS: 30% of 696 swabs taken at T0 were sterile. Contaminated swabs had a high prevalence of coagulase-negative staphylococci, including Staphylococcus epidermidis, and more than 60 different bacterial species were isolated. A significant reduction in microbial load was observed after treatment (>90% of the samples). The microbial load in the control group remained unchanged.
CONCLUSIONS: Liposomal ozonized oil reduced the microbial burden after topical administration in a large study population.