PILOT STUDY: The Effect of Thermal Therapy Using a Rechargeable, Wireless Device on Meibomian Gland Dysfunction
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 主要终点
- Change in Non-Invasive Tear Film Break Up Time (NITFBUT) in Seconds
研究概览
简要总结
The purpose of this pilot study is to determine the feasibility of at home thermal therapy with a wireless, portable device, as an effective management of Meibomian Gland Dysfunction.
This will be done by assessing patients for improvement in symptoms and ocular oil gland function after 4 weeks of a daily thermal therapy application.
详细描述
This study will be a non-randomized, open label study of subjects with documented MGD. All subjects will be sent home with a wireless, portable thermal therapy device and examined pre and post treatment period. Subjects will be asked to use the device at bedtime for 5 minutes daily for 4 weeks. After treatment subjects will be re-examined and measured for clinical and symptomatic change in their MGD as well as changes to their sleep quality and anxiety index. Subjects will also be followed after treatment has been completed.
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
- •Clinical diagnosis of MGD
- •Minimum age 18 years
排除标准
- •History of ocular disease, trauma, surgery (other than refractive), orbital cancer
- •3 month history of ocular infection and/or ocular inflammation not associated with dry eye
- •3 month history of any active physician administered or prescription dry eye treatment
- •Pregnant, potentially pregnant or nursing
研究组 & 干预措施
Thermal Therapy
Heat application using at home thermal therapy device
干预措施: Thermal therapy device (Device)
结局指标
主要结局
Change in Non-Invasive Tear Film Break Up Time (NITFBUT) in Seconds
时间窗: Before and after 4 weeks of daily treatment
Ocular surface analysis of tear film evaporation
次要结局
- Change in Ocular Surface Disease Index (OSDI) Score(Before and after 4 weeks of daily treatment)
- Meibum Expressibility(Before and after 4 weeks of daily treatment)
- Sleep Quality(Before and after 4 weeks of daily treatment)
- State Trait and Anxiety(Before and after 4 weeks of daily treatment)