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Effect of Systemic Ozone Therapy on Corneal Endothelium

NCT07718100 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2026-07-21

No results posted yet for this study

Summary

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.

Conditions

  • Corneal Endothelial Cell Loss
  • Ozone Therapy

Interventions

OTHER

Systemic Ozone Therapy

Major autohemotherapy (MAH) using a medical-grade ozone generator (Ozonosan Alpha Plus, Herrmann Apparatebau GmbH, Germany). Approximately 100 mL of the patient's blood is drawn into a sterile glass bottle containing 3.8% sodium citrate as an anticoagulant. The blood is then exposed to an ozone-oxygen mixture at a concentration of 40 µg/mL. The ozonated blood is gently mixed and reinfused intravenously over 10-15 minutes. The procedure is performed once daily for 10 consecutive sessions.

Sponsors & Collaborators

  • Yuzuncu Yil University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-14
Primary Completion
2026-07-14
Completion
2026-07-14

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07718100 on ClinicalTrials.gov