Intense Regulated Pulsed Light Vs Standard of Care for the Treatment of Meibomian Gland Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Tear film stability
研究概览
简要总结
This study is to evaluate the effectiveness of E>EYE intense regulated pulsed light (IRPL) treatment compared to the current standard of care using a daily warm compress
详细描述
E-Eye is a medical device that has been specifically designed for treating dry eye syndrome due to meibomian gland dysfunction (MGD). This study is a prospective, single centred, interventional, randomized study assessing the efficacy and safety of E>EYE in the management of MGD (3 applications on days 0, 15 and 45, with a follow up 1 month later) compared to daily use of a warm compress over a period of 75 days.
The study will monitor the change in symptoms and signs of dry eye at each visit.)
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
- Single (Investigator)
盲法说明
Ocular assessment will be undertaken by a researcher masked to the participants treatment allocation
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
- •Willing and able to provide informed consent and participate in the required study visit
- •Subjects determined to have signs and symptoms of evaporative Dry Eye disease due to MGD, defined by the following:
- •OSDI score >13 and
- •NITBUT <= 10sec
排除标准
- •No use of warm compresses, intense pulsed light therapy or other lid warming treatment in the past 6 Months
- •Patients with greater 75% meibomian gland loss
- •Presence of ocular pathology or systemic conditions other than previously diagnosed moderate or severe chronic dry eye and/or Sjogren's syndrome, that in the investigator's judgment may affect the testing for, or diagnosis of, dry eye if present
- •Use of prescribed ocular topical medication (e.g., anti-hypertensive, steroid, Cyclosporin A, antibiotic) within the last 24 hours
- •Artificial tear usage within 2 hours prior to study testing
- •Other invasive ocular diagnostic testing within 2 hours prior to study testing
- •Eye makeup present on the eye lid within 10 minutes prior to study testing
研究组 & 干预措施
IRPL
Three treatments with IRPL (manufacturer: E-Swin, France) on days 0, 15 and 45
干预措施: E>Eye IRPL (Device)
Warm compress
Daily use of a warm compress (manufacturer: The Eye Doctor, UK) with Sterileyes® twice a day for 5 minutes
干预措施: Warm compress (Device)
结局指标
主要结局
Tear film stability
时间窗: Change between baseline and day 75
Change in non-invasive assessed tear film retention time from baseline to end of trial
Symptoms of dry eye disease
时间窗: Change between baseline and day 75
Change in Ocular Surface Disease Index (OSDI) questionnaire score from baseline to end of trial
次要结局
- Tear volume(Change between baseline and day 75)
- Lipid layer thickness(Change between baseline and day 75)
- Eye redness(Change between baseline and day 75)
- Meibomian gland patency(Change between baseline and day 75)