A Randomized, Sham Controlled, Masked Phase II Study to Evaluate the Neuroprotective Effect of Hyperbaric Oxygen Therapy on Optic Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Visual Field- Mean Deviation
研究概览
简要总结
The purpose of the study is to evaluate the neuroprotective efficacy of hyperbaric oxygen for the treatment in patients with optic neuropathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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 must meet all of the following criteria to join the study (all eligibility criteria must be met at the screening and baseline visits unless otherwise noted):
- •Participant must be at least
- •Participant must has the ability to comply with the requirements of the study and complete the schedule of events (SOE).
- •Participant's with clinical evidence of optic neuropathy.
- •Participant must understand and sign the informed consent. If the participant's vision is impaired to the point where he/she cannot read the informed consent document, the document will be read to the participant in its entirety.
排除标准
- •Participant is unable to comply with study procedures or follow-up visits.
- •Participant has evidence of corneal opacification or lack of optical clarity.
- •Participant is currently participating in or has within the last 3 months participated in any other clinical trial of a drug by ocular (if in the study eye) or systemic administration.
- •Participant is pregnant or lactating.
- •Participant has, in the opinion of the investigator, any physical or mental condition that would increase the risk of participation in the study or may interfere with the study procedures, evaluations and outcome assessments.
- •Children and comatose patients.
- •Participant abusing drugs or alcohol.
- •Prior treatment with hyperbaric oxygen within the last 6 months.
- •Participant with claustrophobia or that cannot decompress properly.
研究组 & 干预措施
Sham Hyperbaric Oxygen
Participants will get a Sham Hyperbaric oxygen therapy for 20 days
干预措施: Sham Hyperbaric Oxygen (Device)
Active Hyperbaric Oxygen
Participants will get Hyperbaric oxygen therapy for 20 days.
干预措施: Hyperbaric Oxygen (Device)
Open Label
Participants will get Hyperbaric oxygen therapy for 20 days to determine best methods for full trial.
干预措施: Hyperbaric Oxygen (Device)
结局指标
主要结局
Change in Visual Field- Mean Deviation
时间窗: Baseline through 6 months
Humphrey visual field testing with standard MD output
Change in Visual Field- Visual Field Index
时间窗: Baseline through 6 months
Humphrey visual field testing with standard VFI output
次要结局
- Change in Average Thickness Ganglion Cell Complex on Optical Coherence Tomography(Baseline through 6 months)
- Change in Average Thickness Retinal Nerve Fiber Layer on Optical Coherence Tomography(Baseline through 6 months)
研究者
Jeffrey L Goldberg
Professor of Ophthalmology
Stanford University