NCT02196584已完成不适用
Clinical Evaluation of the Rapid Access Vitreal Injection Guide (RAVI-Guide)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Pain severity associated with instrument type used for holding eyelids open during intravitreal injection
研究概览
简要总结
Hypothesis: The RAVI-Guide provides superior patient acceptability to the conventional lid speculum during intravitreal injections
Aims: To compare patient acceptance and procedural complication rates of the RAVI-Guide with those of the conventional lid speculum and caliper approach
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age 18 years or older who undergo intravitreal injection for clinical indications.
排除标准
- •Patients under the age of 18 years
- •Patients unable to give informed consent
- •Disorders that preclude the ability to judge pain or discomfort associated with intravitreal injection
- •Disorders that preclude the ability to assess for complications of intravitreal injection
- •Inability to assess the landmarks by which localization of intravitreal injection sites is determined, such as obscured corneal limbus
- •Inability to communicate directly to the physician and immediately after the procedure the level of pain or discomfort
结局指标
主要结局
Pain severity associated with instrument type used for holding eyelids open during intravitreal injection
时间窗: Within 15 minutes of injection procedure
A pain severity scale of 0 to 10, with 0 being no pain, and 10 being worst imaginable pain, will be used to grade pain severity.
次要结局
- Procedural complications associated with instrument use during intravitreal injection procedure(Within 15 minutes of injection procedure)
研究者
Dennis Han
Professor of Ophthalmology
Medical College of Wisconsin
研究点 (1)
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