Low Level Light Therapy & Skin Pigmentation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Eyelid temperature
研究概览
简要总结
The goal of this clinical trial is to determine if there is a difference in eyelid temperature after low-level light therapy (LLLT) in individuals with different amounts of skin pigmentation and dry eye/meibomian gland disease. Participants will have 3 fifteen minute in office LLLT therapy sessions over a period of approximately 7 to 14 days.
详细描述
The primary objective of the study is to determine if there is a difference in the thermal effect of low-level light therapy (LLLT) in individuals with different skin pigmentation (Fitzpatrick skin type I-IV verses Fitzpatrick skin type V-VI) using a clinically available 633nm LLLT system, the Epi-C-Plus (Espansione group, Bologna, Italy).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Ability to read and understand the study informed consent in English
- •Age 18 years or older at enrollment
- •Individuals with MGD based on one or more of the following clinical signs/symptoms, e.g., meibum quality score of 1-3 (Bron et al.), 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 greater than 12 points.
排除标准
- •Active anterior segment pathology (e.g., bacterial conjunctivitis, microbial keratitis)
- •History of systemic disease associated with aqueous-deficient dry eye disease (e.g., Sjogren's syndrome)
- •History of corneal surgery, refractive surgery, or eyelid surgery within 6 months
- •History of corneal ectasia (e.g. keratoconus, Pellucid marginal degeneration)
- •History of ocular trauma within 6 months
- •History of LipiFlow, iLux, Meiboflow, IPL or LLLT within the last 12 months
- •Habitual use of photosensitizing medications within the last 30 days
- •Pregnant and/or lactating females, by self-report
- •Pigmented lesions, tattoos, or skin cancer in the periocular region
- •Unwilling to have eyes photographed or video recorded
结局指标
主要结局
Eyelid temperature
时间窗: Eyelid temperature will be measured before and after 15 minutes of low-level light therapy at the baseline visit.
次要结局
- Ocular Surface Disease Index Questionnaire(After 3 low-level light therapy treatment sessions through study completion, an average of 1 week.)
- Tear break up time(After 3 low-level light therapy treatment sessions through study completion, an average of 1 week.)
研究者
Eric R. Ritchey
Associate Professor
University of Houston