Randomized Controlled Study of Cooled Versus Room-Temperature Artificial Tears for Reducing Surface Irritation Following Intravitreal Injection
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- The Efficacy of Cooled Versus Room Temperature Artificial Tears in Reducing Post Intravitreal Injection Ocular Discomfort as Measured by Pain Scale Survey.
研究概览
简要总结
Background and Objective: To evaluate the efficacy of cooled versus room temperature artificial tears in reducing post intravitreal injection (IVI) ocular discomfort.
Patients and Methods: Patients receiving IVI were randomized to either cooled or room temperature tears intervention groups. Both groups rated their ocular discomfort following IVI before intervention and again after administration of cooled or room temperature tears.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 105 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients were eligible if they were receiving standard intravitreal injections for their exudative age-related macular degeneration, cystoid macular edema, diabetic macular edema, proliferative diabetic retinopathy, retinal vein occlusion with macular edema, or retinal neovascularization.
排除标准
- •Inability or lack of willingness to participate in the study
- •Active ocular infection including infectious uveitis
- •First time receiving intravitreal injection
- •Those who reported never having ocular discomfort following intravitreal injections on the pre-injection questionnaire
- •Less than 18 years of age
研究组 & 干预措施
Cooled artificial tear group
Stored at 4 degree Celsius
干预措施: Refresh Plus Preservative-free Lubricant Eye Drops (Drug)
Room temperature artificial tear group
Stored at 25 degree Celsius
干预措施: Refresh Plus Preservative-free Lubricant Eye Drops (Drug)
结局指标
主要结局
The Efficacy of Cooled Versus Room Temperature Artificial Tears in Reducing Post Intravitreal Injection Ocular Discomfort as Measured by Pain Scale Survey.
时间窗: with 72 hours of the intervention
The level of subjectively reported pain scale from 1 to 10, where 1 is minimal pain and 10 is extreme pain
次要结局
未报告次要终点