Topical Proparacaine Eye Drops to Improve the Experience of Patients Undergoing Intravitreal Injections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Number of Study Participants With Positive Conjunctival Culture
研究概览
简要总结
The specific aims of this study are to compare patient experience with and without a proparacaine drop after povidone iodine.
详细描述
To ensure the extra drop does not interfere with antisepsis, conjunctival cultures will be obtained from patients undergoing intravitreal injection before and after the application of the extra eye drop. Patients will be randomized to undergo additional topical analgesia during intravitreal injection vs. the standard amount of topical analgesia. Cultures of the eyelid/conjunctiva will be taken to ensure that the additional topical analgesia does not interfere with antisepsis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients undergoing intravitreal injection who do not have active eye infections
- •greater than 18 years of age
排除标准
- •patients younger than 18 years of age
- •patients with active eye infections
研究组 & 干预措施
Standard procedure + Culture
Patients will undergo the standard injection protocol. A conjunctival culture will then be obtained followed by the application of povidone-iodine to the eyelashes and eyelid margins. Patients will be randomized to receive 5% povidone-iodine drop to the conjunctival surface followed by conjunctival culture then re-application of 5% povidone-iodine drop to the conjunctival surface. Injection will then proceed.
干预措施: Conjunctival culture (Procedure)
Proparacaine + Culture
Patients will undergo the standard injection protocol. A conjunctival culture will then be obtained followed by the application of povidone-iodine to the eyelashes and eyelid margins. Patients will undergo application of another drop of topical anesthetic followed by conjunctival culture. After the culture, this group of patients will have 5% povidone iodine applied to the conjunctival surface. Intravitreal injection will then proceed.
干预措施: Proparacaine (Drug)
Proparacaine + Culture
Patients will undergo the standard injection protocol. A conjunctival culture will then be obtained followed by the application of povidone-iodine to the eyelashes and eyelid margins. Patients will undergo application of another drop of topical anesthetic followed by conjunctival culture. After the culture, this group of patients will have 5% povidone iodine applied to the conjunctival surface. Intravitreal injection will then proceed.
干预措施: Conjunctival culture (Procedure)
结局指标
主要结局
Number of Study Participants With Positive Conjunctival Culture
时间窗: pre-injection
Conjunctival samples were collected after participants received either an additional drop of proparacaine or povidone iodine. Bacterial cultures were performed from conjunctival samples by the Mayo Clinic Microbiology laboratory. Bacterial species identification was performed on any and all bacteria that grew.
Pain at the Time of Injection
时间窗: post-injection
Subjects were asked to complete a survey about their experience with intravitreal injections after the procedure was completed. The survey was scored on a 0 to 10 numeric rating scale (NRS) where 0 was a positive response and 10 was a negative response. The lower the score, the lesser the perceived pain, the higher the score, the higher the perceived pain.
次要结局
- Residual Pain From Intravitreal Injection(post-injection)
- Overall Impression of Visit for Intravitreal Injection(post-injection)
- Impression of Pre-injection Preparations(post-injection)
- Comfort With Intravitreal Injection Standard Procedure(post-injection)
- Expectation Intravitreal Injection Will Have Negative Consequences on Subject Health(post-injection)
- Expectation the Injection Will Contribute to Curing/Improving Eye Condition(post-injection)