This study evaluates the safety of systemic ozone therapy on the corneal endothelium, a vital non-renewable tissue that maintains corneal transparency. Ozone therapy is increasingly used for chronic pain, osteoarthritis, fibromyalgia, and other conditions due to its immune-modulating and antioxidant effects. However, its impact on the corneal endothelium has not been thoroughly investigated.
This prospective controlled cohort study includes 96 participants: 48 patients receiving systemic ozone therapy (major autohemotherapy, 40 µg/mL, 10 sessions) and 48 age- and sex-matched healthy controls. Corneal endothelial parameters including endothelial cell density (ECD), hexagonality (Hex%), coefficient of variation (CV), central corneal thickness (CCT), and intraocular pressure (IOP) are measured by specular microscopy at baseline (T0), 1 month (T1), 3 months (T2), and 6 months (T3). Oxidative stress markers (MDA, SOD, GSH-Px) are also assessed in the ozone group.
The primary goal is to determine whether systemic ozone therapy causes any adverse effects on corneal endothelial cells over a 6-month period. Secondary goals include evaluating changes in oxidative stress markers and assessing the correlation between systemic antioxidant effects and corneal health. Results will help guide clinical practice regarding the safety of ozone therapy in patients with or without pre-existing corneal conditions.