Treatment Effect of Intense Pulsed Light and Thermal Pulsation Therapy on Meibomian Gland Dysfunction-associated Dry Eye Disease: a Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Ocular Surface Disease Index (OSDI) questionnaire
研究概览
简要总结
The goal of this clinical trial is to understand novel treatment methods for meibomian gland dysfunction (MGD)-associated dry eye disease (DED) by comparing two treatment modalities- intense pulsed light (IPL) and thermal pulsation therapy (TPT), to find out the difference of their therapeutic mechanisms and treatment effects, so that eye doctors can give more precise advice to the patients when making treatment decisions.
The main questions it aims to answer are:
- What subtype of meibomian gland dysfunction (MGD) better responds to which treatment modality?
- How long do the treatment effects last?
Researchers will compare each group (IPL and TPT) to a control group treated with eyedrops.
* Do combined treatment of IPL or TPT with eyedrops show better outcomes than only eyedrops?
Participants will:
- Receive different treatment for 2 months according to the group they were randomly allocated to.
- Visit the clinic for checkups after 1 and 3 months after completing the treatment sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •individuals diagnosed with meibomian gland dysfunction (MDG)-associated dry eye disease (DED) that are suitable for intense pulsed light (IPL) and thermal pulsation therapy (TPT)
排除标准
- •ocular surgery or trauma in the recent 3 months
- •ocular infection
- •eyelid abnormalities (e.g., entropion, ectropion, lagophthalmos, severe ptosis or trichiasis)
- •blepharospasm
- •eyelid tumor
- •severe meibomian gland atrophy
- •allergic to topical anesthetics
- •sunbathe in recent one month
- •periocular fillers
研究组 & 干预措施
IPL arm
干预措施: Intense pulsed light (Device)
TPT arm
干预措施: thermal pulsation therapy (Device)
Control arm
干预措施: Ocular lubricant (Drug)
结局指标
主要结局
Ocular Surface Disease Index (OSDI) questionnaire
时间窗: From enrollment to the end of post-treatment follow-up at 5 months.
Ocular Surface Disease Index (OSDI) questionnaire was assessed by participants in each follow-ups.
次要结局
未报告次要终点
研究者
Wen-Chuan Kuo
Professor and Director, Institute of Biophotonics, National Yang Ming Chiao Tung University
National Yang Ming Chiao Tung University