Ocular and Palpebral Manifestations of Mastocytosis (MOOMA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Proportion of Subjects with mastocytosis presenting eye abnormalities
研究概览
简要总结
Mastocytosis is a rare condition characterized by an accumulation of mast cell cells in one or more organs such as the liver, bone marrow, spleen and intestines. Its prevalence in the general population is 1 in 10,000.
This pathology is due to the proliferation of a mast cell clone and the excessive release of inflammatory mediators which lead to abnormal tissue infiltration.
To date, there are only a few cases reporting ocular and orbital manifestations of mastocytosis.
Our prospective, interventional and single-center study consist in describing the ocular functional manifestations and ocular surface abnormalities of patients with systemic and cutaneous mastocytosis.
详细描述
Patient with systemic or cutaneous mastocytosis will be included in the study. Data about organ involvement of mastocytosis will be collected. Participants will be screened with a medical and eye disease history. They will also have an eye exam.
Participants will provide a tears sample.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- •Have a diagnosis of mastocytosis
- •Male or female, 18 years of age and over
- •Ability to understand and provide written informed consent.
排除标准
- •Disorders that do not allow good visualization of the posterior pole (cataract, intravitreal hemorrhage)
- •Patients with another ocular pathology that may bias the results (corneal dystrophy, dysthyroid orbitopathy, retinal pathologies)
- •History of refractive surgery
结局指标
主要结局
Proportion of Subjects with mastocytosis presenting eye abnormalities
时间窗: up to 2 hours
Number of patients with functional complaints or abnormalities of the surface, orbit, anterior and posterior segment of the eyeball.
次要结局
- Nature and Frequency of eye abnormalities(up to 2 hours)
- Risk factor of eye abnormalities(up to 2 hours)