Effect of Systemic Ozone Therapy on Corneal Endothelium: A Prospective Controlled Cohort Study With Specular Microscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Change in Coefficient of Variation (CV) of cell area from baseline to 6 months
研究概览
简要总结
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.
详细描述
STUDY DESIGN AND PARTICIPANTS
This is a prospective controlled cohort study conducted at [Institution Name]. The study protocol was approved by the Local Ethics Committee and adhered to the tenets of the Declaration of Helsinki. All participants provided written informed consent.
The ozone group comprised 48 consecutive patients scheduled to receive systemic ozone therapy for various indications including fibromyalgia (16.7%), chronic pain (22.9%), knee osteoarthritis (29.2%), disk herniation (10.4%), peripheral arterial disease (6.3%), and sports injuries (14.6%). The control group consisted of 48 healthy individuals matched for age (±2 years), sex, and body mass index (BMI, ±3 kg/m²) who did not receive ozone therapy.
Exclusion criteria for both groups included: (1) history of ocular surgery or trauma, (2) corneal dystrophy or degeneration, (3) glaucoma or ocular hypertension, (4) diabetes mellitus, (5) contact lens use within the preceding 3 months, (6) active ocular surface disease, and (7) systemic conditions known to affect corneal endothelium.
OZONE THERAPY PROTOCOL
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
Specular microscopy measurements were performed by a single experienced technician who was blinded to group allocation. However, the study was open-label for participants and investigators.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 years or older
- •For ozone group: Patients scheduled to receive systemic ozone therapy for fibromyalgia, chronic pain, knee osteoarthritis, disk herniation, peripheral arterial disease, or sports injuries
- •For control group: Healthy individuals matched for age (±2 years), sex, and body mass index (BMI, ±3 kg/m²)
- •Willing and able to provide written informed consent
- •Willing and able to comply with all study procedures and follow-up visits
排除标准
- •History of ocular surgery or trauma
- •Corneal dystrophy or degeneration
- •Glaucoma or ocular hypertension
- •Diabetes mellitus
- •Contact lens use within the preceding 3 months
- •Active ocular surface disease
- •Systemic conditions known to affect corneal endothelium
- •Any condition that, in the opinion of the investigator, would interfere with study participation or evaluation of outcomes
结局指标
主要结局
Change in Coefficient of Variation (CV) of cell area from baseline to 6 months
时间窗: Baseline (T0), 1 month (T1), 3 months (T2), and 6 months (T3)
Coefficient of variation in endothelial cell area (%), measured by non-contact specular microscopy (Topcon SP-3000P).
Change in Endothelial Cell Density (ECD) from baseline to 6 months
时间窗: Baseline (T0), 1 month (T1), 3 months (T2), and 6 months (T3)
Endothelial cell density (cells/mm²) measured by non-contact specular microscopy (Topcon SP-3000P) from the central cornea.
Change in Hexagonality (Hex%) from baseline to 6 months
时间窗: Baseline (T0), 1 month (T1), 3 months (T2), and 6 months (T3)
Percentage of hexagonal corneal endothelial cells measured by non-contact specular microscopy (Topcon SP-3000P).
次要结局
- Change in Malondialdehyde (MDA) levels from baseline to 6 months(Baseline (T0), 1 month (T1), 3 months (T2), and 6 months (T3))
- Change in Superoxide Dismutase (SOD) activity from baseline to 6 months(Baseline (T0), 1 month (T1), 3 months (T2), and 6 months (T3))
研究者
Sebahattin Celik MD
Professor
Yuzuncu Yil University