Comparative Study of Eyelid Position Interdependence in Involutional Ptosis Patients Submitted to 1, 2 or 4 Drops of 10% Phenylephrine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Upper lid height before and after phenylephrine test lower lid height before and after phenylephrine test
研究概览
简要总结
The primary aim of this study is to quantify eyelid position changes in tested and opposite eyes in ptosis patients submitted to 1, 2 or 4 drops of 10% phenylephrine in one eye. The secondary objective is to correlate the eye dominance, severity and laterality of ptosis with eyelid position changes in these 3 groups.
详细描述
This is a prospective observational study conducted in involutional ptosis patients, which will be submitted to instillation of a single drop of 10% phenylephrine in one eye(Group 1), 2 drops (G2) or 4 drops ( G3).
Video camera will record the images of both eyes before and after drug application at 3, 10, 15 and 30 minutes. The images will be edited to analyze upper and lower lid height.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Involutional blepharoptosis
- •Upper Margin-reflex distance less or equal 2.0mm
- •Good fixation and collaboration
排除标准
- •Previous eyelid surgeries
- •Use of adrenergic or sympathicomimetics drugs
- •Myopathies
- •Thyroid orbitopathy
- •Non-controlled cardiovascular disease
结局指标
主要结局
Upper lid height before and after phenylephrine test lower lid height before and after phenylephrine test
时间窗: 3, 10, 15 and 30 minutes
次要结局
- Scobee test to detect eye dominance(15 minutes before 10% phenylephrine instillation)