Therapeutic Effect of Intense Regulated Pulse Light in Patients With Dry Eye Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Tear Meniscus Height
研究概览
简要总结
The aim of this study is to assess the effect of intense regulated pulse light (IRPL) on the treatment of Dry eye.
详细描述
Dry eye disease is a common ocular condition that needs prompt diagnosis and careful treatment interventions. If left untreated, it can lead to numerous sight threatening complications, including ulceration of the cornea, blepharitis, alterations of the tear film, conjunctivitis, and in severe cases, significant drying of the eye may lead to scarring, thinning, and even perforation of the cornea.
Intense pulsed light (IPL) therapy is a new treatment strategy for treatment of MGD by inducing the restoration of the normal activity of the meibomian glands. In fact, IPL has been used for treating the patients with facial telangiectasias and erythema of rosacea and also resulted in improvement in ocular surface health.
Evaporative form is the commonest form of DED and it is mainly caused by meibomian glands dysfunction (MGD). The usual traditional treatment options for MGD include warm compresses, expression of meibomian glands (MG), anti-inflammatory drugs, and lubricant eye drops.
The aim of this study is to assess the effect of intense regulated pulse light (IRPL) on the treatment of Dry eye.
The study included 34 patients with moderate to severe evaporative dry eye. The symptoms will be assessed with the Dry Eye-Related Quality of Life Score (DEQ-5) Questionnaire. The tear film will be assessed through MediWorks D130+S390L (WDR) which is a device attached to the slit lamp for non-invasive examination of tear film.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with moderate to severe dry eye disease & clinicaily significant signs of meibomian gland dysfunction
排除标准
- •Use systemic medications known to affect the eye two weeks prior to baseline assessment.
- •Pregnancy.
- •Ocular surgery or dermatologic treatments in the previous Two months or during the treatment period.
- •Implants, tattoos, or pigmented lesions in the treatment area.
- •Contraindications to IPL therapy, including the use of photosensitive medications.
结局指标
主要结局
Tear Meniscus Height
时间窗: before treatment
assessment of tear film through MediWorks device attached to the slitlamp
Change in Tear Meniscus Height
时间窗: Within 1 month after completion of treatment
assessment of tear film through MediWorks device attached to the slitlamp
Lipid layer thickness
时间窗: before treatment
assessment of tear film through MediWorks device attached to the slitlamp
Non-invasive tear film break up time
时间窗: before treatment
assessment of tear film through MediWorks device attached to the slitlamp
Change in Non-invasive tear film break up time
时间窗: Within 1 month after completion of treatment
assessment of tear film through MediWorks device attached to the slitlamp
Change in Lipid layer thickness
时间窗: Within 1 month after completion of treatment
assessment of tear film through MediWorks device attached to the slitlamp
Change in Meibomian glands % loss grading
时间窗: Within 1 month after completion of treatment
assessment of tear film through MediWorks device attached to the slitlamp
Change in patient's quality of life affection
时间窗: Within 1 month after completion of treatment
The effect of dry eye on the patient's Quality Of Life was evaluated with the aid of Dry Eye-Related Quality of Life Score (DEQ-5) Questionnaire.
Meibomian glands % loss grading
时间窗: before treatment
assessment of tear film through MediWorks device attached to the slitlamp
patient's quality of life affection
时间窗: before treatment
The effect of dry eye on the patient's Quality Of Life was evaluated with the aid of Dry Eye-Related Quality of Life Score (DEQ-5) Questionnaire.
次要结局
未报告次要终点
研究者
Rofaida Mostafa Mansour Serag EL Deen
Ophthalmologist at Menoufia university hospitals
Menoufia University