CONTROLLED CLINICAL TRIAL ON THE USE OF OZONATED BLOOD AS A TREATMENT FOR RETINITIS PIGMENTOSA.
N. Moreno, O. Peláez, T. Alemán, C. Barceló. International Reference Center of Retinitis Pigmentosa "Camilo Cienfuegos", Cuba.
The aim of this study is to determine the effects of ozone as a therapy for patient with retinitis pigmentosa. A double blind, placebo controlled study was designed, in which 123 patients, ages 15 to 65 years, and suffering from typical forms of retinitis pigmentosa participated Sixty two patients were randomly assigned to the treatment group and 61 to the control group. A complete general and ophthalmologic examination was performed after signing an informed consent Snellen visual acuity was measured (less than 2.5 lines considered non significant changes) and Goldmann kinetic visual field with 31.5 asb. background and V-4e target. Visual field areas were digitized and measured with a computer program (VISUAL). Ozonated blood was administered to patients in the treatment group, in a daily fashion for 15 days, while patients in the control group received only blood. Participants were blind with regards to this, throughout the duration of the study Visual acuity remained the same, 6 months after the treatment, in 74.2 % of the patients, improve in 21 % and worsen in 4.8 %. Visual field area remained the same, 6 months after the treatment, in 41.9 % of the patients, improve in 46.7 % and worsen in 11.35 %. Significant differences were observed between groups, with lower frequencies of improvements in controls are larger proportions of worsening. Improvements were not observed in 91.9 % of patients one year after the treatment. This tendency was first noted after 6 months from the treatment. Ozone treatment is proved of benefit in patients with RP, although its action is temporary. Repeated administration after 6 months is recommendable to maintain its action.