Wound Healing Effectiveness, After Deep Anterior Lamellar Keratoplasty, Of A Medical Thermogel Based On Liposomal Ozonated-Oil

The purpose of this Interventional, Monocentric, Controlled, Randomized, Phase 4 Study, was to evaluate the reparative and antimicrobial activity of a medical thermogel based on liposomal ozonated-oil in addition to standard therapy with corticosteroid–antibiotic (Group 1) in the management of 70 patients after deep anterior lamellar keratoplasty vs patients undergoing standard therapy alone (Group 2).

Villa Igea - Ospedali Privati, Viale Antonio Gramsci 42, Forlì (FC). Università degli studi di Ferrara, Ferrara (FE)

The antimicrobial efficacy was evaluated in terms of reduction of total conjunctival microbial load. Treatment lasted 3 days after surgery. The conjunctival swabs were taken from the eyes of the patients enrolled in the study (Group 1 and Group 2) at T0 (before starting the treatment) and T4 (4 days after treatment) and sent to the laboratory within 24 hours for microbiological evaluation.

In group 1 (Ozonated oil + CA) the elimination of bacteria was virtually complete (close to a “zero contamination state”), with a significant reduction in microbial load after treatment, remarkably higher than control group (CA). In group 1 we reached a “zero-contamination” condition.

The wound healing process was optimized by the administration of the gel, without phenomena of toxicity in the ocular surface, in spite of the antiseptic nature of ozonated oil; therefore, ocular tolerability of the solution was optimal, probably due to its liposomal nature.

The study has proved, according to the recent scientific literature available, the antiseptic effectiveness of a topical administration of a new ophthalmic gel based on a liposomal ozonated-oil in a clinical sample. Considering the high variability of «in vivo» isolated bacteria on the ocular surface, the regional variation, the presence of uncommon species with high potential pathogenicity, and the multi-target antiseptic effect of ozonated-oil, an adjuvant prophylaxis with ozonated-oil solution, in addiction to (and complementary to) the only antibiotic used in the operating theatre, could be a new antiseptic strategy preferable to the current prophylaxis with antibiotics only.