Effects and Prognostic Factors of Intensive Pulse Light Treatment for Meibomian Gland Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Change from baseline tearfilm break-up time at 2 weeks after the last treatment session
研究概览
简要总结
The investigators are going to Investigate the comparative efficacy of intense pulsed light therapy alone with that of intense pulsed light plus meibomian gland expression for meibomian gland dysfunction.
详细描述
Enrolled patients are going to be randomly assigned to two groups. All of the patients will undergo four treatment sessions in total, which are two weeks apart. Group 1 will undergo two sessions of intense pulsed light therapy with meibomian gland expression, as well as two sessions of intense pulsed light alone. Group 2 will receive two sessions of intense pulsed light therapy alone, and two sessions of intense pulsed light therapy with meibomian gland expression. The following parameters will be measured at baseline, 2 weeks after the second treatment session, and 2 weeks after the fourth treatment session: tearfilm break-up time, Oxford grade for corneal staining, meibomian gland expressibility, meibum quality, and ocular surface disease index.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of meibomian gland dysfunction
排除标准
- •Medical conditions in which IPL is contraindicated (pregnancy, breastfeeding, lupus, and any major uncontrolled health problem).
- •Contact lens wearer
- •Previous ocular surgery
- •Previous thermal treatment for dry eye disease (e.g. LipiFlow)
结局指标
主要结局
Change from baseline tearfilm break-up time at 2 weeks after the last treatment session
时间窗: Baseline and 2 weeks after the last treatment session
Change from baseline ocular surface disease index at 2 weeks after the last treatment session
时间窗: Baseline and 2 weeks after the last treatment session
The ocular surface diseases index score range from 0 to 100 based on the result of standardized ocular surface disease index questionnaire. Higher value represent worse subjective symptom.
Change from baseline meibomian gland expressibility score at 2 weeks after the last treatment session
时间窗: Baseline and 2 weeks after the last treatment session
The meibomian gland expressibility was assessed on a scale of 0 to 3 in five glands on the central lower lid. It was scaled according to the number of glands expressible, as follows: 0 (all glands), 1 (three to four glands), 2 (one to two glands) and 3 (no glands)
Change from baseline meibum quality score at 2 weeks after the last treatment session
时间窗: Baseline and 2 weeks after the last treatment session
The meibum quality score were divided into the following four degrees: 0 (clear), 1 (cloudy), 2 (granular), and 3 (toothpaste)
Change from baseline Oxford grade for corneal staining at 2 weeks after the last treatment session
时间窗: Baseline and 2 weeks after the last treatment session
Oxford grade for staining was assessed on a scale of 0 to 5. It was scaled according to the degree of corneal staining as follow: 0 (absent), 1 (minimal), 2 (mild), 3 (moderate), 4 (marked), and 5 (severe)
次要结局
未报告次要终点
研究者
tae-young chung
Professor
Samsung Medical Center