Evaluation of Low-Level Light Therapy on Meibomian Glands Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Meibum protein composition
研究概览
简要总结
The goal of this clinical trial is to examine the effect of low-level light therapy (LLLT) on meibomian gland dysfunction and dry eye disease. The main questions it aims to answer are:
- Does low-level light therapy reduce levels of pro-inflammatory proteins in meibum
- Does low-level light therapy increase the ratio of non-polar lipids to polar lipids in meibum
Participants will receive 3 15-minute sessions of low-level light therapy. Meibum will be collected before the first treatment and after the final treatment.
详细描述
Low-level light therapy (LLLT) is a treatment for meibomian gland dysfunction. The proposed mechanism of action is photobiomodulation of cells leading to improved adenosine triphosphate synthesis, reduction of reactive oxygen species in oxidatively-stressed cells, and the activation of transcription factors involved in cellular proliferation, migration and survival. Understanding of how low-level light therapy based therapy alters meibomian gland function is poor. This study will examine the effect of low-level light therapy on individuals with meibomian gland dysfunction. Eligible subjects will receive 15 minutes of low-level light therapy per week over a 3 week period. Meibum collected prior to treatment will be compared to meibum collected after 3 treatment sessions for alteration in protein and lipid composition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Age 18 years or older at enrollment
- •Individuals with mild to moderate meibomian gland dysfunction based on clinical signs, e.g., meibum quality score of 1-3, meibography score of 1, 2, or 3 on the Pult Meiboscale, non-invasive 1st tear break up time of 10 seconds or less, or an Ocular Surface Disease Index (OSDI) score of 13 to 32 points
排除标准
- •History of systemic disease associated with aqueous-deficient dry eye disease (e.g., Sjogren's syndrome)
- •History of corneal surgery, refractive surgery, eyelid surgery or ocular trauma within 6 months
- •History of LipiFlow, iLux, Meiboflow, Intense Pulsed Light (IPL) or low level light therapy (LLLT) within the last 12 months
- •Use of photosensitizing medications
- •Pregnant and/or lactating females
- •Pigmented lesions, tattoos, or skin cancer in the periocular region
研究组 & 干预措施
Low-Level Light Therapy
All subjects will receive 3 15-minute treatments of low level light therapy
干预措施: Red Low-Level Light Therapy (Device)
结局指标
主要结局
Meibum protein composition
时间窗: 3 weeks
Proteomic analysis of meibum collected before and after low level light therapy
次要结局
- Meibum lipid composition(3 weeks)
研究者
Eric R. Ritchey
Assistant Professor
University of Houston