To evaluate the antimicrobial effectiveness of a liposomal ozonised-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 endophthalmitis cases.
Twenty Italian experimental centres of the ELOOM (Effectiveness of Liposomal Ozonised-oil on Ocular Microbial flora before cataract surgery) study group.
An interventional, non-randomised, paired-eye designed, Phase 4 clinical study
A total of 174 patients undergoing cataract surgery were divided into two groups: the study group (174 eyes) underwent surgery and received an isotonic ophthalmic solution of 0.5% ozonised oil in liposomes plus hypromellose treatment (2 drops 4 times/day), 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, 4 days before surgery) and at T4 (after 3 days of treatment, 10 min before surgery) and sent to the laboratory within 24 h of collection for microbiological analysis.
Thirty percent of 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.
Liposomal ozonised oil reduced the microbial burden after topical administration in a large study population.