NCT04500821已完成不适用
Evaluation of the LipiFlow System With a New Activator (Model LFD-2100)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 6
- 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.
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
研究者
研究点 (6)
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