Clinical Comparison of Two Anesthetic Preparations for Intravitreal Injection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Discomfort Level and Patient Satisfaction With the Preparation Protocol and Intravitreal Injection
研究概览
简要总结
Patient comfort during and after eye injections will be compared after two numbing (anesthetic) protocols, an eye preparation utilizing three cotton swabs soaked in 4% lidocaine drops versus a preparation using 3.5% lidocaine hydrochloride ophthalmic gel.
详细描述
The primary goal of this investigation is to determine the relative comfort of an intravitreal injection (same day and the next day) after a preparation utilizing three cotton swabs soaked in 4% lidocaine versus a preparation using 3.5% lidocaine hydrochloride ophthalmic gel. Based on the available data, the researchers contend that a preparation based on viscous 3.5% ophthalmic lidocaine gel, which coats the surface and remains in contact with the eye longer, may provide greater anesthesia and result in greater patient comfort than the topical 4% lidocaine, which is part of the standard preparation routinely utilized in the ophthalmology department currently. Secondary outcome measure is the intraocular pressure rise after the injection, and the authors will generate prospective data to study whether softening the eye with cotton swabs prior to the injection lowers post-injection pressure spike.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •Has required repeat Ranibizumab injections and has had at least 3 injections prior to recruitment
- •Informed consent
- •Age ≥ 18 years
- •Clinical need for a therapeutic ranibizumab intravitreal injection regardless of the medical indication
- •Able to understand and read English
排除标准
- •Pregnancy (positive pregnancy test)
- •Mental disability
- •Prisoners
- •Patients with fluctuating or impaired decision-making capacity
- •Inability to comply with study or follow-up procedures
- •Previous reaction to the same drug class
研究组 & 干预措施
4% lidocaine
Eyes were anesthetized with 0.5% proparacaine and then with three cotton swabs soaked in 4% liquid lidocaine applied with moderate pressure to the site of the injection inferotemporally to the limbus. Each participant was assigned to have this prep during one of the consecutive study visits if unilateral or in one eye if patient requires bilateral injections given the same day
干预措施: 4% lidocaine (Drug)
3.5% ophthalmic lidocaine gel
Eye was anesthetized with 0.5% proparacaine and then with 3.5% ophthalmic lidocaine gel applied to the surface of the eye. Each participant was randomly assigned to receive this preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day.
干预措施: 3.5% ophthalmic lidocaine gel (Drug)
结局指标
主要结局
Discomfort Level and Patient Satisfaction With the Preparation Protocol and Intravitreal Injection
时间窗: immediately after injection, 1- hour later, and next day
Discomfort according to the Eye Sensation Scale: 1-none, 2- mild, 3- moderate, 4- severe, 5- extremely severe Patient satisfaction scale: 1=very unsatisfied, 2=unsatisfied, 3=neutral, 4=satisfied, 5= extremely satisfied
次要结局
- Intraocular Pressure Change After Intravitreal Injection With Each Anesthetic Method, Results Reported in mmHg(immediately after injection, at 5, 10, 15 minutes)
- Presence and Severity of Keratopathy and the Size of Subconjunctival Hemorrhage(within 10 minutes of the injection)
研究者
Ninel Gregori
Assistant Professor of Clinical Ophthalmology
Miami VA Healthcare System