Lipiflow Effect on Lacrimal Meibum Composition and on Adverse Environmental Conditions in Subjects With Meibomian Gland Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Tear break up time (TBUT)
研究概览
简要总结
Meibomian glands are a kind of sebaceous gland located in the tarsus of lower and upper lids and their function is to express lipids to the tear film. The secretion of lipids, polar and no-polar, produced in the Meibomian glands is denominated as meibum and it forms the external layer of the tear film. Its thickness varies from 15 to 200 nm and it is related with the tear film stability and the evaporation of the tear film.
The meibum composition is variable among participants, especially in those who suffer Meibomian gland dysfunction or dry eye disease. Meibomian gland dysfunction is the leading cause of ocular surface disease.
Meibomian gland dysfunction management depends on its severity, but eyelid hygiene, including warming and expression of Meibomian gland, is recommended from clinical stage 1 and it has proven its efficacy. However, lack of participant compliance can be a problem when this therapy is prescribed. In the last few years, some devices have been developed to improve the efficacy of this therapy, as for example the application of Vectored Thermal Pulsation with the Lipiflow device.
It has been reported that low relative humidity values increase evaporative rates in both dry eye participants and healthy participants. Also, our group has extensively proven the negative effect of adverse environments (in the Controlled Environment Laboratory (CELab)) in clinical variables such as tear stability, dry eye symptoms and corneal staining both in healthy and dry eye participants.
Therefore, the hypothesis of this study is that improving the Meibomian gland secretion through the application of warm and pressure with Lipiflow device, meibum composition would change in participants with Meibomian gland dysfunction and they would be less affected by adverse environmental conditions simulated in a controlled environmental chamber.
The study will try to assess the effect of Lipiflow on the meibum in patients exposed to controlled adverse environmental conditions.
详细描述
Justification:
Meibomian glands are a kind of sebaceous gland located in the tarsus of lower and upper lids and their function is to express lipids to the tear film. Each gland consists of several acini surrounding a central conduct and connected to it by conducts. The internal side f the gland is not visible, while the external one is located in the lid margin, before the muco-cutaneous junction, where they express the lipids to the tear film. Meibomian glands from lower lids are thicker than those of upper lid.
The secretion of lipids, polar and no-polar, produced in the Meibomian glands is denominated as meibum and it forms the external layer of the tear film. Its thickness varies from 15 to 200 nm and it is related with the tear film stability and the evaporation of the tear film. The lipid layer is divided in two sub-layers: the no-polar external part and the polar internal part. This internal part creates and inter-phase between the tear film muco-aqueous layer and the lipid no-polar layer, contributing to its stability. The no-polar lipids retards the evaporation of the aqueous component of the tear film so, inhibits the inflammation produced by the evaporation.
The meibum composition is variable among participants, especially in those who suffer meibomian gland dysfunction or dry eye disease.
Meibomian Gland Dysfunction is the leading cause of ocular surface disease. There has been substantial confusion regarding its definition and the origin of its symptoms. In part because of this uncertainty, the prevalence of this disease is unknown, and numbers are highly variable. A survey performed in the USA estimated a prevalence of 37 percentage and 47 percentage as reported by ophthalmologists and optometrists, respectively.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 18 or older.
- •Signature of informed consent form.
- •Ocular Surface Index (OSDI) questionnaire score more or equal
- •Meibomian gland secretion score of the lower lid in both eyes less or equal 12 in the Meibomian Gland Yielding Liquid Secretion (MGYLS) Score.
- •At least 10 out of 15 functioning MG of the lower eyelid, evaluated with the Meibomian Gland Evaluator (MGE).
排除标准
- •Any ocular pathology other than Ocular Surface Disease due Meibomian Gland Dysfunction (MGD).
- •Unwilling to abstain from the use of systemic or topical treatments for MGD or dry eye for the study duration (except for artificial tears, ocular lubricants or dietary supplements).
- •Unwilling to abstain from the use of systemic medications known to cause dryness for the study duration.
- •History of severe ocular inflammation or infection in the 6 previous months.
- •Eyelid abnormalities that affect lid function.
- •Any ocular surgery or trauma that may affect corneal sensitivity and/or normal tear distribution in the 6 previous months.
- •Contact lens use must be stopped 15 days before inclusion and will not be resumed until the end of the study.
- •Punctal plugs or punctal occlusion within the past three months.
- •Pregnancy or breastfeeding.
结局指标
主要结局
Tear break up time (TBUT)
时间窗: 3 months after treatment
Measure of tear film stability with fluorescein. Tear Break Up Time with fluorescein (TBUT): fluorescein sodium (Entod Research Cell United Kingdom Ltd, New Southgate, London, United Kingdom) will be instilled in the inferior conjunctiva. Tear film pattern will be observed through a slit lamp with blue light and yellow filter. Participants will be asked to blink three times and then maintain their eye open as longer as possible. The time between the last blink and the moment when the first black spot appears will be noted in seconds. This measure will be repeated three times and the average of them will be calculated. Measures lower than 8 seconds are considered no normal.
次要结局
- Meibomian Gland Score (MGS) 12 months after treatment(12 months after treatment)