Meibomian Gland Probing in the Sub-Acute Phase of Patients With Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Meibomian gland imaging (Meibography) - Qualitative description
研究概览
简要总结
The investigators' aim is to study the effects of mechanical expression of meibomian glands on eyelid disease, ocular surface health in the subacute phase of SJS/TEN.
The primary outcome is to use meibomian gland imaging to assess the health and caliber of the meibomian glands of both lower eyelids, between the treated and non-treated eyes before and after the intervention. Monitoring of outcomes will be measured by comparing the results of meibography at the initial visit and at the 6-month follow-up.
The secondary outcome assessed will be patient symptoms. The Ocular Surface Disease Index survey will be administered before each treatment and patients will be asked to differentiate their symptoms between the two eyes, both before and after the intervention.
The investigators hypothesize that mechanical expression of meibomian glands within the first 6 months of SJS/TEN onset will significantly improve ocular surface disease and symptoms in those patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 是
入选标准
- •Patients with SJS/TEN presenting to the Massachusetts Eye and Ear Infirmary (MEEI) ophthalmology clinic or who were seen by the ophthalmology team acutely at the Massachusetts General Hospital (MGH).
- •Patients must be in the Sub-acute phase of ocular SJS (within 6 months)
- •Patients must have evidence of Meibomitis
- •Patients must be adults (18 years of age or older)
排除标准
- •Patients with unconfirmed diagnosis of SJS vs. Erythema multiforme (or other condition).
- •Patients beyond the sub-acute phase of SJS
- •Patients without evidence of Meibomitis (See above criteria)
- •Patients under the age of 18
结局指标
主要结局
Meibomian gland imaging (Meibography) - Qualitative description
时间窗: 6 months
To assess the appearance of the meibomian glands of both lower eyelids, before and after the intervention.
次要结局
- Ocular Surface Disease Index survey(6 months)
研究者
Hajirah N. Saeed, M.D.
Principal Investigator
Massachusetts Eye and Ear Infirmary