Thermal Pulsation System for the Treatment of Meibomian Gland Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- ocular discomfort
研究概览
简要总结
The current study aims to test the efficacy of treatment for a device that utilises a thermal pulsation system, which applies heat from the inner surface of the eyelids (Lipiflow) in patients suffering from meibomian gland dysfunction.
Patients will be asked to undergo a one-time treatment with Lipiflow and the investigators will monitor them for changes in tear film and lipid composition, as well as changes in the anatomy of meibomian glands for over a study period of 12 weeks. Additionally, dry eye symptoms will be documented in form of questionnaires.
The investigators hypothesize that the treatment will be effective in improving clinical signs and will relieve dry eye symptoms for the patient. If this method of managing Meibomian Gland Dysfunction (MGD) is found to be efficacious and safe, it will be made available to patients in Singapore.
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
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eyelids must present with blocked meibomian gland openings (plugs), at least 1 visible MG plug in the 4 eyelids, or discernable change in consistency of meibum (increased in viscosity or opacity) when MG expressed in upper or lower eyelids.
- •At least one out of 8 questions on dry eye symptoms is answered with often or all the time.
- •Eyes should not show any other ocular surface pathology which required more treatment than eye lubricant and conventional eyelid hygiene.
排除标准
- •Known history of thyroid disorders (diagnosed by physician).
- •No ocular surgery within the previous 6 months and LASIK within the previous 1 year.
- •Any intake of central nervous system and hormonal drugs within last 30 days and inability to withhold such drugs for at least 6 weeks.
- •Active ocular infection or pterygium.
- •Anticipated necessity to wear contact lens in the duration of the study.
- •Living in the same household as another participant of the study.
- •Any other specified reason as determined by clinical investigator, for example, the need to use any treatment or eyedrops not permitted by the study.
结局指标
主要结局
ocular discomfort
时间窗: 3 months
次要结局
- Tear Break Up Time (TBUT)(3 months)
- Number of blocked meibomian glands(3 months)
- Corneal fluorescein staining score(3 months)
- To measure the production of tears(3 months)
- Tear evaporimetry(3 months)
- Lipid layer thickness(3 months)
研究者
Louis Tong
Clinician-Scientist
Singapore National Eye Centre