Evaluation of the LipiFlow System With a New Activator (Model LFD-2100)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 3
- 主要终点
- Successful Completion of LipiFlow Treatment With Activator LFD-2100
研究概览
简要总结
Minimum 50 eyes and up to 100 eyes will be treated in this prospective, open-label clinical study. The investigator or designee will perform LipiFlow treatment with the Activators LFD-2100 on both eyes of a subject. The data from the treatment reports generated by the LipiFlow console and from the questionnaire will be used to assess the clinical utilization of the Activator LFD-2100. This study will be conducted in up to four sites in the USA.
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
- •To be able to participate in this study, subjects must:
- •Be at least 22 years old.
- •Has been diagnosed as bilateral MGD prior to the study visit, or has evidence of MGD in both eyes. NOTE: MGD diagnosis can be based on prior medical records, investigator opinion or based on assessment of meibomian glands of the lower eyelid.
- •Availability, willingness, ability and sufficient cognitive awareness to comply with study protocol, examination procedures and visit.
- •Be willing to provide informed consent and authorization to disclose protected health information or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical procedures.
- •Ability to understand and respond in English.
排除标准
- •Subject will not be able to be in the study, if the subject:
- •Has a history of certain medical conditions that have been identified as contraindications and precautions of the LipiFlow System
- •Has a history of prior eye surgery or trauma, active eye disease, or other eye abnormality in the study eye(s), which in the opinion of the investigator would confound the study results.
- •Is pregnant, or is breast feeding.
- •Concurrent participation or expected participation in an interventional (i.e., surgical or pharmaceutical interventional) clinical trial within 14 days prior to study screening.
研究组 & 干预措施
Activator LFD-2100
LipiFlow treatment with the Activators LFD-2100 will be performed on both eyes with MGD
干预措施: Activator LFD-2100 (Device)
结局指标
主要结局
Successful Completion of LipiFlow Treatment With Activator LFD-2100
时间窗: 1 day after completion of LipiFlow treatment
Evaluation of the clinical use of the LipiFlow system with the Activator LFD-2100
次要结局
未报告次要终点