Meibomian Gland Dysfunction Management to Relieve Contact Lens Discomfort
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Symptomatic relief
研究概览
简要总结
The purpose of this study is to compare electronic debridement of the eyelid margin (BlephEx) to manual debridement of the eyelid margin as treatment options for patients intolerant to contact lens wear consequent to 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
- •Habitual contact lens wearers whose contact lens wear time has reduced due to MGD will be preferentially considered for this study. Subjects who currently cannot wear contact lenses due to MGD may be considered on a case-by-case basis.
排除标准
- •Subjects who are currently using any prescription ophthalmic medications (such as antibiotics, steroids and immunomodulatory drugs) will be excluded from participation.
- •Subjects who have active ocular infections will be excluded from participation.
研究组 & 干预措施
BlephEx
The subjects who are enrolled in this arm will undergo electronic lid margin debridement using the BlephEx instrument.
干预措施: BlephEx (Device)
Manual debridement
The subjects who are enrolled in this arm will undergo manual lid margin debridement using a stainless steel ophthalmic golf spud.
干预措施: Manual debridement (Device)
结局指标
主要结局
Symptomatic relief
时间窗: 60 days
Betterment of symptoms (improvement in contact lens discomfort) will be measured using two different surveys - Ocular Surface Disease Index (OSID) and Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8). The OSDI scores can range from 0 to 100. The CLDEQ-8 scores can range from 0 to 37. In both the questionnaires, a lowering of the score during follow-up visits represents a betterment of symptoms suffered by the patient. The numerical change in the scores on these two questionnaires will be documented as the change in symptom profile of the patient (betterment / worsening / stability).
次要结局
- Tear break-up time(60 days)
- Meibography(60 days)
- Lissamine green staining grade of the lid margin(60 days)
- Inflammatory activity(60 days)