Prospective, Randomized, Controlled Comparison of an Automated Thermal Pulsation Treatment (Lipiflow ®) and a Standard Lid Hygiene Regime
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change of Dry Eye Symptoms
研究概览
简要总结
Recently, beneficial effects on Meibomian gland dysfunction (MGD) of a single automated thermal pulsation with the Lipiflow® system have been reported in several case reports. In one study this treatment was compared with hyperthermia (iheat®) for 4 weeks. However, treatment recommendations for lid hygiene according to the MGD-report consist of hyperthermia followed by lid massage and lid margin cleansing over several months. To the best of the investigators knowledge this is the first randomized prospective study to compare automated thermal pulsation treatment with the new Lipiflow ® system with a standard lid hygiene regime.
The investigators suggest that a single treatment with Lipiflow® is superior to a lid hygiene regime.
详细描述
Once a patient has been identified as a possible candidate for the study, he/she is first informed verbally and in writing about the study. After signing the consent form he/she will be randomized to either the Lipiflow® treatment (Lipiflow® group) or alternatively be given an instruction sheet and a verbal explanation for lid warming and massage (lid hygiene group). After 3 month a cross-over of the lid hygiene group to the Lipiflow® group is conducted.
A full examination is performed before and 4 weeks and 3 months after therapy. All tests are performed by a physician or trained graduate students of the Department of Ophthalmology, Heinrich-Heine University. The examiner is blinded, i.e. he does not know which treatment the patient will receive or receiving.
Treatment Lipiflow®:
The automated thermal pulsation with Lipiflow® provides is a low risk therapy. After local anesthesia the applicators are inserted. These look like a kind of goggles and consist of two parts which embrace the eyelids from the front and from behind. Through the rear part heat is applied to a maximum of 42.5° C. By isolating the heat remains on the eyelid limited. Through the front part the gland a massage is performed. The treatment takes 12 minutes per eye and can be done depending on the patient's wishes simultaneously or one eye after the other. The therapy is approved by the FDA as a medical technical innovation and has also been approved by ISO and CE Mark certification for use in Europe. Irritation or minor trauma of the eyelids and the conjunctiva and cornea, as well as a violation of the eyelids and the conjunctiva and cornea are theoretically possible, but extremely unlikely. Permanent damages to the eyes have not been reported in the literature.
In the unlikely event, that complications occur during treatment, requiring an additional treatment, this is performed in the department of ophthalmology of the Heinrich-Heine University Duesseldorf.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •All patients with meibomian gland dysfunction requiring treatment (defined below),
- •who have given their written consent to the study.
- •Meibomian gland dysfunction requiring treatment is classified by us as:
- •Speed score> 7, Lipiview <61 nm, MGE <5 of 15 open glands
排除标准
- •Excluded are patients who, due to other diseases would not be able to fulfill the follow-up appointments or give an informed consent to the study
- •Systemic medication with tetracyclin derivatives, antihistamines, isotretinoin, or nutritional supplements for MGD that started <3 months before baseline examination
- •Topical cyclosporine-A or steroids that started <1 month before baseline examination
- •Ocular surgery or trauma <3 months before baseline examination
- •Any eyelid abnormalities
- •Systemic diseases resulting in dry eye.
结局指标
主要结局
Change of Dry Eye Symptoms
时间窗: after 3 month compared to baseline value
The symptoms of dry eyes are measured in our study with the OSDI and the SPEED questionaire. Primary outcome measure (OSDI) Patients completed two symptom questionnaires: OSDI (Ocular Surface Disease Index) and SPEED (Standard Patient Evaluation of Eye dryness). OSDI scores range from 0 (no symptoms) to 100 (severe symptoms). SPEED scores range from 0 (no symptoms) to 28 (severe symptoms). So a reduction of the OSDI or SPEED score indicates an improvement of subjective dry eye symptoms.
次要结局
- Change in Lipid Layer Thickness(after 3 month compared to baseline value)
- Change in Expressible Meibomian Glands(after 3 month compared to baseline value)
- Change of Break-up-time(after 3 month compared to baseline value)
- Change in Tear Film Osmolarity(after 3 month compared to baseline value)
研究者
David Finis, MD
Principal investigator, department of ophthalmology
Heinrich-Heine University, Duesseldorf