NCT04829799撤回4 期
Effect of Intracameral Phenylephrine/Ketorolac on Intraoperative Pain
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Visual analog scale to measure pain
研究概览
简要总结
To compare the effect of intraoperative intracameral Omidria (Phenylephrine and Ketorolac 1.0%/0.3%) verses 1% Lidocaine on pain reduction during and after cataract surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with a cataract in the surgical eye
排除标准
- •Patients that have previously exhibited sensitivities to acetylsalicylic acid, phenylacetic acid derivative, and other nonsteroidal anti-inflammatory drugs (NSAIDs)
- •Those with a past medical history of asthma
- •Those systemically using opioids or nonsteroidal anti-inflammatory drugs
- •Those prescribed additional topical mydriatics, topical steroids, pilocarpine, or prostaglandins in the week preceding surgery
- •Those with a history of alpha-1-adrenergic antagonist use
- •Those with excisional, intraocular surgery in the planned surgical eye in the preceding year
- •Those with a history of iris damage
- •Those requiring iris expanding device or those with an acute or chronic uncontrolled eye condition, or those unable to effectively remember surgery or complete the post-operative assessment.
- •Additionally, individuals less than 21 will be excluded.
研究组 & 干预措施
Control Group
Active Comparator
Subjects will receive intracameral 1% preservative-free lidocaine following paracentesis
干预措施: 1% preservative-free lidocaine (Drug)
Study Experimental Group
Experimental
Subject will receive Omidria (phenylephrine and ketorolac (1.0%/0.3%) added to the ophthalmic irrigating solution during the cataract extraction procedure
干预措施: Phenylephrine 1.0%/ Ketorolac 0.3% (Drug)
结局指标
主要结局
Visual analog scale to measure pain
时间窗: Day 1 of operation
Measurement of pain intensity by mean visual analog scale (VAS) pain scores from 0 (no pain) to 10 (extreme pain) during operation
次要结局
未报告次要终点
研究者
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