Clinical Effect of MiboFlo in Dry Eye Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- subjective symptom score
研究概览
简要总结
The aim of this prospective study is to compare the changes between the patients receiving traditional treatment and the patients with MiBoFlo, evaluating the effectiveness of MiBoFlo.
详细描述
The MiBoFlo Thermoflo uses a proprietary thermoelectric heat pump to help meibum maximize liquefaction, improving the preservation and function of the tear film's evaporative component. It supplies continuous controlled heat to the outer skin of the eyelids, absorbing deep into the tissue and breaks down the hardened oils in the meibomian glands. We are trying to find a effective, safe and economical therapy for dry eye patients.
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
- 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
- •18 years of age of older;
- •Meet the diagnostic criteria for dry eye developed by DEWS II: OSDI score≥15 points, TBUT≤10 minutes;
- •Meet the signs of meibomian gland dysfunction
排除标准
- •Had skin allergies or inflammation;
- •Had active ocular infection or inflammation;
- •Had history of ocular surgery, eyelid surgery or neurological paralysis within 6 months;
- •Had history of systemic disease affecting ocular surface function, such as Stevens-Johnson syndrome, Sjögren syndrome etc.
结局指标
主要结局
subjective symptom score
时间窗: 2 weeks
Ocular Surface Disease Index (OSDI©) questionnaire was chosen to assess subjective symptoms of dry eye, which can demonstrate sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease.
Meibomian Glands Yielding Liquid Secretion (MGYLS)
时间窗: 2 weeks
The total number of MGYLS was counted for both upper and lower lid of each eye.
Meibomian Glands Secretion (MGS)
时间窗: 2 weeks
The total number of MGYLS was counted for both upper and lower lid of each eye.
次要结局
- Tear Meniscus Height(TMH)(2 weeks)
- Non-invasive Keratograph Break-up Time(NIKBUT)(2 weeks)
- Meibography(2 weeks)
- Corneal Fluorescein Staining(CFS)(2 weeks)