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临床试验/NCT01027611
NCT01027611已完成3 期

Patient Assessment of Topical Anesthetic Effectiveness for Intravitreal Injections

Illinois Retina Associates1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2009年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
120
试验地点
1
主要终点
Injection experience "grade"

研究概览

简要总结

There are currently several different commercially available topical eye drops and gels used to reduce eye discomfort (topical anesthetics) during and after eye injections. Dr. Pollack is performing a research study to evaluate three commercially available topical anesthetics (eye numbing treatments) to determine if individuals have a preference for one over the other. The three topical anesthetics being studied are 1) 0.5% proparacaine hydrochloride (generic, Akorn, Inc), 2) 0.5% proparacaine hydrochloride (generic, Akorn, Inc) PLUS 4% lidocaine hydrochloride topical solution (generic, Roxane Laboratories), and 3) 3.5% lidocaine hydrochloride ophthalmic gel (Akten, Akorn, Inc). These eye anesthetics are NOT experimental medications. They are all commercially available topical anesthetics currently used in our offices and their use is widespread among retina specialists throughout the United States. Dr. Pollack will randomly select one topical anesthetic to use and he will ask you to grade your level of pain associated with the injection procedure. Answering these questions should take less than one minute of your time and your identity will NOT be revealed with the results of this study. The results of this study will be used to inform doctors which eye anesthetics patients find most effective for pain control during eye injections.

详细描述

In this prospective study, 120 sequential patients undergoing 30 and 33 Gauge intravitreal injections were randomly assigned to receive either: proparacaine HCL 0.5% (Group 1), proparacaine HCL 0.5% + 4% lidocaine liquid drops (Group 2); or 3.5% lidocaine gel (Group 3) as topical anesthetic prior to injection. All procedures utilized a lid speculum and 5% povidone iodine. Approximately 10 seconds after injection, patients graded pain associated with the lid speculum, the needle, and with burning sensation on a pain scale of 0 to 10, with 0 representing no pain and 10 representing the patient's worst imaginable pain. They also graded their overall injection procedure experience as Excellent, Very Good, Fair, Poor, or Awful.

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
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

  • Patients requiring intravitreal injection for treatment of eye disease

排除标准

  • Eye infection
  • Retinal detachment
  • Age less than 18 years
  • Unable or unwilling to provide informed consent

研究组 & 干预措施

proparacaine HCL 0.5%

Experimental

干预措施: proparacaine HCL 0.5% (Drug)

proparacaine + lidocaine

Experimental

干预措施: proparacaine HCL 0.5% + 4% lidocaine solution (Drug)

lidocaine gel

Experimental

干预措施: 3.5% viscous lidocaine gel (Drug)

结局指标

主要结局

Injection experience "grade"

时间窗: Outcome data is obtained approximately 10 seconds after conclusion of procedure

次要结局

  • Pain grades for lid speculum, needle insertion, povidone iodine burning/stinging(Outcome data is obtained approximately 10 seconds after conclusion of procedure)

研究者

申办方类型
Other

研究点 (1)

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