Free Papers

Antiseptic effectiveness of new liposome ozonized-oil eye drops for patients undergoing cataract surgery

Free Paper Details

First Author: L.Spadea ITALY

Co Author(s):    M. Giannico   M. Formisano                 

Abstract Details

Purpose:

Presurgical antisepsis is crucial to lower periocular and conjunctival microbial load, thus minimizing the risk of ocular infection. Currently, the most widely used antiseptic in ophthalmic surgery is the povidone-iodine 5% solution, which has a wide spectrum of action but according to the ESCRS guidelines, it cannot ensure a complete sterilization of the ocular surface by itself. The purpose of the study was to evaluate the antimicrobial effectiveness of a new ophthalmic liposome ozonated-oil solution, used as home-therapy, in 200 patients undergoing cataract surgery. The antimicrobial efficacy was evaluated as a load reduction of the most common bacteria isolated in endophthalmitis.

Setting:

The study was carried out in 20 ophthalmological surgical centers (including University and Public Hospitals) in Italy, located throughout the national territory. The study was conducted in accordance with the recommendations of Italian Ethics Committees.

Methods:

Interventional, Non-Randomized, Parallel group, Phase4 Study. 400 eyes of 200 patients undergoing cataract surgery in one eye were divided into two groups: • study group: 200 eyes undergoing surgery received a liposome ozonated-oil eye drops treatment (1 drop 4 times/day); • control group: 200 contralateral eyes were used as untreated controls. Treatment lasted 3 days. The conjunctival swabs were taken from both eyes of every patient enrolled in the study (treated eye and control eye) at T0 (before starting the treatment)and T3 (3 days after the treatment, just before surgery)and sent to the laboratory within 24 hours for microbiological analysis.

Results:

30% of the swabs taken at T0 resulted to be «sterile». Contaminated swabs presented a prevalence of Coagulase-negative staphylococci (CNS, including Staphylococcus epidermidis), in accordance with ESCRS data. CNS was isolated in 66,8% of the swabs, Staphylococcus aureus in 13,9%, other species including gram+ as Streptococcus mitis, Micrococcus spp and gram- as Pseudomonas aeruginosa, Proteus mirabilis were identified at lower rates. More than 90% of the samples presented a significant reduction (>90%) of microbial load after liposome ozonized-oil treatment. Microbial load of the control group remained unchanged. Ocular tolerability of the solution was optimal, probably due to its liposomal nature.

Conclusions:

The new ophthalmic solution based on a liposome ozonated-oil showed antiseptic effectiveness after topical administration in a large study population. We found a high variability of bacteria isolated «in vivo» from ocular surface along with the presence of uncommon microbial species with high potential pathogenicity. Given the wide antiseptic spectrum of ozonated-oil solution, an adjuvant home-prophylaxis should be considered in patients undergoing surgery. The treatment could enhance the standardized povidone-iodine solution used intraoperatively and represent an effective alternative to the current preoperative antibiotic prophylaxis.

Financial Disclosure:

-