Assessment of Novel Intraocular Injection Guide
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Visual Analogue Scale (VAS)
研究概览
简要总结
To determine if a novel intraocular injection guide (IIG) reduces patient discomfort during and after intravitreal injections.
详细描述
This study is being conducted to assess the potential for an intraocular injection guide to increase comfort levels both during and after such injections. The hypothesis is that patients will feel increased comfort from a device which eliminates the need for a speculum while still keeping the eyelids apart, allowing a physician to deliver treatment. The results of this study will allow physicians to select the optimal device for patient comfort and well-being during intravitreal injections
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
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
- •Subjects must be receiving bilateral injections of the same dose of vascular endothelial growth factor (VEGF) inhibitor
- •Injections in both eyes must be given on the same day
- •Male or female age 18 years or older
排除标准
- •Any condition or reason that precludes the subject's ability to comply with the study -
结局指标
主要结局
Visual Analogue Scale (VAS)
时间窗: one time for about 30 sec or less
The VAS is a horizontal line, 100 mm in length, and anchored by word descriptors at each end. The scale scores range from 0mm (no pain) to 100mm (very severe pain). The patient marks on the line the point that they feel represents their perception of their current state (no pain to very severe pain).
次要结局
未报告次要终点
研究者
Raj Maturi
President
Maturi, Raj K., M.D., P.C.