Does Hyperbaric Chamber Improve the Functionality and Symptoms Related to Central Retinal Vein Occlusion (CRVO)?
试验速览
- 阶段
- 2 期
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Optical Coherence Tomography Measurements of the Retina
研究概览
简要总结
Hyperbaric chamber treatment assists in increasing the amount of oxygen in the plasma and in the tissues and has been proven to be beneficial in treating different ischemic wounds, and acute retinal artery occlusion (ARAO) but its effect hasn't been tested in CRVO patients yet.
详细描述
Trial protocol V2.0 - Hyperbaric chamber treatment to CRVO patients
Assaf HaRofe Medical Center - Zerifin, Israel
Purpose: To determine whether hyperbaric chamber treatment improves the functionality and symptoms related to CRVO
Introduction:
Central Retinal Vein Occlusion (CRVO) has profound effects on retinal circulation. As this vein collects the entire venous outflow from the retina, retinal perfusion is greatly impaired when it occludes. Even though, as compensation, the collateral outflow is expanded but nevertheless there is an increase in retinal venous pressure, venous dilation, retinal hemorrhage and retinal edema.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age 18-80 years with a documented CRVO who treated by Avastin for more than 12 months.
- •Patients who signed an informed consent form
排除标准
- •Patients with Carotid stenosis of more than 70%
- •Anemia of < 10mg/Dl
- •Patients with chest X ray pathology which cannot be admitted to hyperbaric chamber treatment.
- •Patients with claustrophobia or that cannot decompress properly.
- •Patients with any malignant disease
- •Patients with inability to sign informed consent
- •Exclusion Criteria:
结局指标
主要结局
Optical Coherence Tomography Measurements of the Retina
时间窗: up to 40 treatments (expected average of 8 weeks)
This is a non-contact medical imaging technology similar to ultrasound and MRI. With OCT, reflected light is used to produce detailed cross-sectional and 3D images of the eye.
次要结局
未报告次要终点
研究者
Assaf Harofeh MC
Dr. Shai Efrati
Assaf-Harofeh Medical Center