Comparative Evaluation of Patient Comfort Following Intravitreal Injections Using Iheezo Versus Standard Anesthesia in a Private Retina Practice
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Discomfort after injection
研究概览
简要总结
Prospective comparative clinical study.
One hundred eyes of 50 patients were included. All patients received bilateral same-day intravitreal injections, with Iheezo administered to only one randomly selected eye and standard topical anesthesia administered to the contralateral control eye. Ocular discomfort was assessed using a 0-10 numeric rating scale at 2 minutes, 1 hour, 6-12 hours, and 24 hours following injection. The primary longitudinal analysis used a linear mixed-effects model incorporating treatment group, assessment time, and treatment-by-time interaction as fixed effects and patient as a random effect. Between-group differences at individual time points were evaluated using Welch two-sample comparisons with Holm adjustment for multiple comparisons. Patient-level mean discomfort across the four assessments was also compared between groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Anyone receiving bilateral same day intravitreal injections as standard care
排除标准
- •Inability to complete post-injection survey
- •History of receiving Iheezo
研究组 & 干预措施
No iheezo
Standard anesthesia alone
干预措施: Lidocaine pledget (Drug)
Iheezo
Standard anesthesia plus iheezo prior to injection
干预措施: Iheezo (Drug)
结局指标
主要结局
Discomfort after injection
时间窗: 2 minutes to 24 hours after injection
Rated 0-10 in each eye
次要结局
未报告次要终点
研究者
Travis Peck
Principal Investigator, physician
Retina Consultants of Delmarva
