Clinical, Meibographic and Interferometric Evaluation of Phlyctenular Keratitis in Children - MEIBO-ROSACEE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Number of abortive blinks
研究概览
简要总结
The aim of this study is to describe the clinical, meibographic and interferometric manifestations of phlyctenular keratitis in children.
详细描述
The investigators are conducting a monocentric, transversal, epidemiologic study. 100 patients should be included: 50 children suffering from ocular rosacea, and 50 children with no palpebral or Meibomian disease. Witnesses will be matched on the age of the cases.
Patient and controls will undergo a classic ophthalmologic examination with visual acuity measurement and slit lamp examination of both eyes and eyelids. Then, the child will go through a meibographic and interferometric evaluation of his two inferior eyelids. This evaluation is made by an optometrist with the Lipiview device, and lasts a few minutes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recruited from a specialized ophthalmologic consultation Rothschild Ophthalmologic Foundation, Paris, France.
- •Cases : suffering from ocular or oculo-cutaneous rosacea
- •Witnesses : without any present or past palpebral or meibomian disease
排除标准
- •Unable to achieve the meibographic and interferometric examination (Lipiview)
结局指标
主要结局
Number of abortive blinks
时间窗: Day of inclusion
Number of abortive blinks during the Lipiview exam
Clinical severity
时间窗: Day of inclusion
Clinical severity is determined with a composite score, by the presence of chalazia, corneal lesions, neovascularization, phlyctena, loss of vision, superficial keratitis, anterior and posterior keratitis, meibomitis, palpebral margin keratinization, lagophthalmos, long term use of azithromycin treatment, treatment by ciclosporin eyedrops, intense cutaneous or ocular symptoms, long time evolution of the disease.
Meibographic severity
时间窗: Day of inclusion
The meibographic severity is determined by the level of Meibomian gland atrophy, data obtained with the Lipiview
Interferometric severity
时间窗: Day of inclusion
The interferometric severity is evaluated by the thickness of the lipid layer tear film, data obtained with the Lipiview
次要结局
未报告次要终点