A Prospective, Clinical Trial Eye Lipid Mobilizer (ELM) Using Heat and Vibration for the Treatment of Meibomian Gland Dysfunction (MGD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Procedure-related adverse events
研究概览
简要总结
The goal of this clinical trial is to evaluate the Eye Lipid Mobilizer (ELM) for the treatment of evaporative dry eye disease associated with meibomian gland dysfunction. The main questions aim to confirm that 1) the ELM can meet its intended use by validated patient reporting outcomes and 2) to confirm that the ELM device can be used safely by different users within a clinical environment as determined by review of any adverse events related to the use of the device.
详细描述
The purpose of the clinical study is to evaluate the Eye Lipid Mobilizer for the treatment of evaporative Dry Eye Disease associated with Meibomian Gland Dysfunction. The objective of the study is to confirm that the Eye Lipid Mobilizer (ELM) can meet its intended use by validated patient reporting outcomes.
The secondary objective is the ELM device can be used safety with no adverse events. The Eye Lipid Mobilizer (ELM) System is intended for the application of localized heat and vibration therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye.
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
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 21 years old
- •Confirmed evaporative dry eye disease
排除标准
- •Ocular surgery, trauma, herpes infections
- •Unwillingness to comply with study protocol
- •Pregnant or nursing women
- •Any subject that cannot wear an eye mask
- •Participation in another ophthalmic clinical trial within past 30 days
结局指标
主要结局
Procedure-related adverse events
时间窗: one week, four weeks
Incidence of procedure-related adverse events will be assessed
Device-related adverse events
时间窗: one week, four weeks
Incidence of device-related adverse events will be assessed
次要结局
- Slip Lamp Evaluation(one week, four weeks)
- Corneal Fluorescein Staining(one week, four weeks)
- SPEED II Questionnaire for Dry Eye(one week, four weeks)
- Lipid Layer Thickness(one week, four weeks)
- Meibomian Gland Imaging(one week, four weeks)
- Tear Break Up Time(one week, four weeks)