Pilot Study for Evaluation of LipiFlow Screening Methods
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Association Between Screening Methods (Meibomian Gland Expression) and Treatment Effectiveness Outcomes (Total Meibomian Gland Score)
研究概览
简要总结
The objective is to evaluate the feasibility of using additional screening methods to optimize effectiveness outcomes with the LipiFlow System for application of heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye, and chalazia. The screening methods include diagnostic expression of the meibomian glands and interferometry assessment of the tear film.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meibomian gland dysfunction
- •Dry Eye symptoms
排除标准
- •Ocular surgery, ocular injury or ocular Herpes infection within past 3 months
- •Active ocular infection
- •Active ocular inflammation or recurrent inflammation within past 3 months
- •Moderate to severe allergic conjunctivitis
- •Severe eyelid inflammation
- •Eyelid abnormalities that affect lid function
- •Ocular surface abnormalities that may compromise corneal integrity
- •Systemic disease conditions or medications that cause dry eye
- •Use of other treatments for meibomian gland dysfunction or dry eye
- •Pregnant or nursing women
- •Participation in another ophthalmic clinical trial within past 30 days
结局指标
主要结局
Association Between Screening Methods (Meibomian Gland Expression) and Treatment Effectiveness Outcomes (Total Meibomian Gland Score)
时间窗: Baseline and 4 Weeks
Analysis of association between Baseline Meibomian Gland Expression Score and Total Meibomian Gland Score at 4 Weeks. Success was defined by demonstration of a statistically significant (p\<0.05) association between the screening method and outcome. Meibomian gland expression sum scores range from 0 to 60 with a higher score reflecting less meibomian gland dysfunction. Total meibomian gland scores range from 0 to 45 with a higher score reflecting less meibomian gland dysfunction.
次要结局
未报告次要终点