NCT03012698已完成不适用
Pilot Study for Testing Safety of Repetitive Magnetic Stimulation for Treatment of Dry Eye
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 3
- 主要终点
- Best Corrected Visual Acuity (BCVA)
研究概览
简要总结
The study aims to test the safety of Repetitive Magnetic Stimulation (RMS) treatment for dry eye disease. Patients are asked to undergo a one-time treatment with Epitech Ocular Magnetic Stimulation Device on one eye in the first stage and both eyes sequentially in the second stage of the study. Changes are monitored for over a study period of 3 months.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females, 18-80 years old
- •Subjects with moderate to severe dry eye syndrome
- •Subjects able to understand the requirements of the protocol and provide informed consent.
排除标准
- •Eyes with other ocular surface pathology which requires more treatment than eye lubricant and conventional eyelid hygiene
- •A concurrent ocular disease including ocular infection or pterygium.
- •Ocular surgery within the previous 6 months and LASIK within the previous 1 year.
- •Any ocular injury or ocular Herpes infection within past 3 months
- •Anticipated necessity to wear contact lens in the duration of the study.
- •Unstable thyroid disorders (Drugs Tx not stable in the last 3 months).
- •Pregnant or nursing women
- •Documented HIV positive
- •Cardiac pacemakers, cardioverter defibrillators, or neurostimulators, cochlear implants, implanted medication pumps or intracardiac lines, implanted brain electrodes (cortical or deep-brain electrodes)
- •Any Conductive, ferromagnetic or other magnetic - sensitive objects such as aneurysm clips or coils, stents, bullet fragments in the head or neck
- •Significant heart disease or cerebrovascular disease
- •History of epilepsy, dementia, head trauma, increased intracranial pressure, or central nervous system (CNS) tumors.
- •Participation in another ophthalmic clinical trial within past 30 day
- •Any other specified reason as determined by the clinical investigator.
结局指标
主要结局
Best Corrected Visual Acuity (BCVA)
时间窗: 3 mounth
次要结局
未报告次要终点
研究者
研究点 (3)
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