Liposomal Ozonised-Oil: An Effective Tool In Reducing Ocular Microbial Flora In Patients Undergoing Cataract Surgery

To assess the antimicrobial effectiveness, evaluated as reduction of total conjunctival bacterial load, of an ophthalmic liposomal ozonated-oil solution, used as home-therapy, in patients undergoing cataract surgery vs control.

20 Italian experimental centers of the Effectiveness of Liposomal Ozonized oil on Ocular Microbial flora before cataract surgery study group.

A prospective, interventional, non-randomized, paired-eye designed, phase 4 clinical study was performed on 348 eyes of 174 patients undergoing cataract surgery. All the eyes were divided into 2 groups: the study group (174 eyes) received a liposomal ozonated-oil solution in the eyes to be operated (1 drop 4 times/day). The control group (174 contralateral eyes) were used as untreated control. Treatment lasted 3 days. The conjunctival swabs were taken from all eyes (treatment and control) at T0 (before starting the treatment) and T4 (3 days after treatment and immediately before surgery) and sent to the laboratory within 24 hours for microbiological evaluation.

30% of the analysed swabs taken at T0 were «sterile». The positive swabs presented a prevalence of Coagulase-negative staphylococci (CNS, including Staphylococcus epidermidis). CNS was isolated in 66.8% of the swabs, Staphylococcus aureus in 13.9%; other species were identified at lower rates, including Gram+ as Streptococcus mitis, Micrococcus spp and Gram- as Pseudomonas aeruginosa, Proteus mirabilis. 64 different bacterial species were isolated, including zoonotic and fecal bacteria. Samples analysed presented a significant reduction (~92%) in microbial load after treatment with liposomal ozonized-oil solution; control group remained unvaried. Tolerability of the solution was very good.

The study has proved the antiseptic effectiveness of a new ophthalmic solution based on a liposomal ozonated-oil in a large clinical sample. These could be a new antiseptic strategy in addiction (and complementary) to the only povidone-iodine used in the operating theatre, improving preoperative prophylaxis procedures in eye surgeries.