Comparison of BlephEx to MiBoflo as Treatment Options for Blepharitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Ocular irritation symptoms (OSDI Questionnaire score)
研究概览
简要总结
The goal of this study is to compare which treatment - BlephEx or MiBoFlo - will be a better option for patients suffering from dry eye secondary to Meibomian Gland dysfunction.
详细描述
The investigators have previously studied the effect of the BlephEx instrument (debridement of lid debris) in relieving signs and symptoms of blepharitis (Connor CG et al, ARVO 2014). This previous study demonstrated positive results from the BlephEx treatment. Warming the eyelids (e.g., using warm wash cloths) still remains a viable treatment option for this disease. However, patients are often non-compliant with warm compress therapy due to the requirement of performing it at least twice per day. The MiBoflo delivers uniform and consistent amounts of heat to the eyelid. It is suggested that two treatments over 30 days is adequate to relieve signs and symptoms of Meibomian gland dysfunction. This equipment is currently used in optometric practices in this country.
There are no clinical studies comparing BlephEx and MiBoflo as treatment options for blepharitis. Hence, the current study will provide new and useful information on which treatment option may be better for treating blepharitis and Meibomian gland dysfunction. Part of this study will also investigate if a combination of BlephEx and MiBoflo treatments is more beneficial to the patient. The data generated will directly benefit clinical practice and impact several millions of patients who suffer from this Blepharitis and / or Meibomian gland dysfunction.
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
- •Must have dry eye secondary to Meibomian gland dysfunction (posterior blepharitis)
排除标准
- •Must not have active ocular surface infections. Must not be currently using steroids or immunosuppression eye drops.
研究组 & 干预措施
BlephEx treatment
Treatment with the BlephEx instrument (lid margin exfoliation)
干预措施: Blephex (Device)
MiBoFlo treatment
Treatment with the MiboFlo equipment (heat therapy to eyelids)
干预措施: MiboFlo (Device)
结局指标
主要结局
Ocular irritation symptoms (OSDI Questionnaire score)
时间窗: one month
次要结局
- Tear break-up(one month)
研究者
SRIHARI NARAYANAN
Professor
University of the Incarnate Word
