Eyelid Warming Technology for Relief of Meibomian Gland Dysfunction in an Asian Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Dry Eye Symptoms
研究概览
简要总结
Meibomian gland dysfunction (MGD), an extremely common clinical condition (seen in more than half of some Asian populations), affects the lipid producing meibomian glands in the eyelids. One function of the glandular secretions is to reduce evaporation of the tear film. In MGD the meibomian glands may become blocked for various reasons. The consequential retention and stasis of the secretion increases immune response as well as scarring response. This eventually results in an abnormal tear film and dry eye symptoms.
The current standard treatments include warm moist compresses, regular lid hygiene, oral antibiotics, topical antibiotic ointments and Omega 3 supplementation. Heating for an extended duration is important because it relieves the occlusion of blocked meibomian glands. However, improvised methods of heating are cumbersome and inefficient requiring repeated measures, often leading to lack of compliance. Today, there is a wider range of commercially available devices that help to unblock meibomian glands and relief dry eye symptoms. These devices may improve MGD treatment dramatically, but have not been tested in the warm climate of Singapore, and are not readily available.
The current study aims to test the efficacy of treatment for devices that utilize A) warm moisture (Blephasteam) and B) warmth (EyeGiene) in patients suffering from meibomian gland dysfunction. Patients will be asked to use Blephasteam and EyeGiene for a period of 4 weeks. The study will monitor patients for changes in tear film and lipid composition, as well as changes in the anatomy of meibomian glands. Additionally, dry eye symptoms will be documented in form of questionnaires. If the newer methods of managing MGD are found to be efficacious and safe, these treatment measures can be made available to patients in Singapore.
详细描述
Study Objectives and Purpose:
- A primary purpose of the study is to compare the efficacy of novel eyelid warming devices (Blephasteam and EyeGiene) for treatment of meibomian gland dysfunction by objective clinical scoring and objective assessment of ocular surface parameters in an Asian population.
- The second aim is to assess the patient acceptance of these modalities, in terms of comfort and convenience.
- A third aim of the study is to document Meibomian gland disease using non-invasive Meibography, and the possible alterations of this condition after treatment.
Study Design: Prospective, controlled, single masked, interventional study
Rationale:
Meibomian gland dysfunction and resulting evaporative dry eye is highly common in our general population. Behavioral factors and environmental stress may contribute to the severity of the disease. Eyelid warming devices have the potential to significantly improve meibomian gland health and alleviate dry eye symptoms associated with the disease. Currently eyelid warming devices suitable for treatment of meibomian gland dysfunction are not available in Singapore.
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)
入排标准
- 年龄范围
- 21 Years 至 90 Years（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 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 (Appendix C, Questionnaire modified after Schein et al.,1997).
- •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 (eg. Restasis) not permitted by the study.
研究组 & 干预措施
EyeGiene
EyeGiene (Eyedetec Medical Inc., US) is a self-contained, convenient warm compress system for the eyes. The system is composed of a reusable eye mask and one time use warmers that are inserted into the eye mask. The warming units are activated by squeezing just prior use and deliver 40°C heat for up to 5 minutes within 30-60 seconds.
干预措施: EyeGiene (Device)
Blephasteam
Blephasteam (Spectrum Théa, France) is an eyelid warming device that can be conveniently used at home. The goggles provide standardised heat of about 38 degrees to liquefy lipids and also humidify the chambers with mineral water to ensure optimal moisture levels.
干预措施: Blephasteam (Device)
Control- Hot Compress
The participants in this group will be using warm compresses with a hot towel.
干预措施: Hot compresses (Device)
结局指标
主要结局
Dry Eye Symptoms
时间窗: Week 4
A VAS will be applied to evaluate dry eye symptoms as described by Schaumberg et al. (Schaumberg 2007)between baseline and week 4. The scores will be recorded separately for frequency and severity of dry eye symptoms.
次要结局
- Tear meniscus volume(Week 4)
- Meibography(Week 4)
- Yamaguchi Score(Week 4)
- Corneal Staining(Week 4)
- Number of plugs(Week 4)
- Tear film break up time(Week 4)
- Schirmer's Test(Week 4)
- Tear composition(Week 4)
- Meibomian gland lipids(Week 4)
研究者
Louis Tong
Clinician-Scientist, Consultant
Singapore National Eye Centre