Innovative Imaging of the Conjunctiva, Cornea, and Ocular Adnexa : Study of a Handheld in Vivo Confocal Microscope and of a Fluorescent in Vivo Confocal Microscope
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Diagnostic performance (sensitivity (se) and specificity (sp)) of the handheld IVCM in ocular surface and adnexa diseases
研究概览
简要总结
In vivo confocal microscopy (IVCM) used in tertiary care ophthalmology centers is performed with two reflectance microscopes attached on a mounting with limited movement along the XYZ axes. Consequently, ocular diseases in the central area have been described (mostly cornea and adjacent conjunctiva). Two dermatology IVCM (an handheld small IVCM and a multifluorescent one) present significant innovations that the investigators want to assess in ophthalmology for the diagnosis of conjunctiva, cornea, eyelid and lachrymal tract diseases. The handheld IVCM have unlimited degrees of freedom and a small diameter objective. It could dramatically increase the area accessible to IVCM (whole conjunctiva, eyelids, proximal lachrymal tract) (part 1 of the present study). The fluorescent IVCM allows the use of a wide range of fluorescent markers liable to increase the specificity of the diagnosis by revealing staining patterns corresponding to a specific disease and not to others (part 2 of the study)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Presenting with an ocular or ocular adnexa disease (infectious keratitis, stromal dystrophy, corneal surgery, ocular surface toxicity of eyedrops, cornea-conjunctival tumors, chronic blepharitis, eyelid tumors, diseases of the proximal lachrymal tract).
- •For the microangiography: diabetic patients
排除标准
- •Allergy to one of the 3 dyes (fluorescein, indocyanine green, rose Bengal)
- •Pregnancy and breast feeding
- •Predicable impossible follow up
- •For patient volunteer for intravenous injections: beta blockers
结局指标
主要结局
Diagnostic performance (sensitivity (se) and specificity (sp)) of the handheld IVCM in ocular surface and adnexa diseases
时间窗: 1 year
次要结局
- fluorescence : characteristics of the micro-angiography(1 year)
- handheld IVCM : sensitivity (se) and specificity (sp) in each 8 subgroups of diseases(1 year)
- handheld IVCM : positive and negative predictive values in each 8 subgroups of diseases(1 year)
- handheld IVCM : determining the limits of the tumor(1 year)
- fluorescence : staining patterns obtained for each disease group(1 year)
- handheld IVCM : AUC of the ROC curve in each 8 subgroups of diseases(1 year)
- handheld IVCM : factors influencing image quality(1 year)