NCT05945069已完成不适用
Feasibility of Dynamic Muscle Stimulation (DMSt) Combined with Radiofrequency (RF) for Improving Blink Quality in Subjects with Dry Eye Disease (DED)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Impaired blink quality
研究概览
简要总结
To demonstrate that DMSt + RF improves eye blink quality in subjects with dry eye disease
详细描述
The purpose of the study is to demonstrate that a combination of DMSt and RF applied on the periocular skin below the lower eyelids improves eye blink quality in subjects with moderate to severe signs and symptoms of dry eye disease.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is able to read, understand and sign an Informed Consent Form (ICF)
- •22 or older
- •Lower lid laxity, as clinically judged with lower lid DT and the snapback test
- •Moderate to severe OSDI (larger or equal to 23)
- •TBUT smaller or equal to 5 sec in both eyes
排除标准
- •Abnormally high blink rate, as estimated by the study investigator
- •Any ocular surgery or eyelid surgery, within 3 months prior to screening
- •Blepharoptosis
- •Moderate or Severe Floppy Lid Syndrome
- •Corneal Dystrophy
- •Exophthalmos
- •Thyroid Eye Disease
- •Ocular Chemical Injury or burn
- •Limbal Stem Cell Deficiency
- •Facial Nerve Palsy
- •Blepharospasm
- •Hemifacial Spasm
- •Corneal neuropathy
- •Pregnant or nursing women
- •Participation in a different study
- •Any condition revealed whereby the study investigator deems the subject inappropriate for this study
结局指标
主要结局
Impaired blink quality
时间窗: 7 weeks after baseline (4 weeks after the 4th treatment)
binary (yes/no) variable, based on clinical estimation of the study investigator who will use a combination of two complementary tests (the lower lid distraction test and the snap-back test) to reach a yes/no decision.
次要结局
未报告次要终点
研究者
研究点 (2)
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