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临床试验/NCT07779356
NCT07779356已完成4 期

Comparative Evaluation of Patient Comfort Following Intravitreal Injections Using Iheezo Versus Standard Anesthesia in a Private Retina Practice

Retina Consultants of Delmarva1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年5月20日最近更新:
适应症
干预措施
相关药物

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

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

Placebo Comparator

Standard anesthesia alone

干预措施: Lidocaine pledget (Drug)

Iheezo

Experimental

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

发起方
Retina Consultants of Delmarva
申办方类型
Other
责任方
Principal Investigator
主要研究者

Travis Peck

Principal Investigator, physician

Retina Consultants of Delmarva

研究点 (1)

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