Topical Lidocaine Gel With and Without Subconjunctival Lidocaine Injection for Intravitreal Injection: a Within-patient Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Number of Participants Who Preferred Subconjunctival Anesthetic at the Third Follow-up Visit
研究概览
简要总结
Since 2004, intravitreal injection of Avastin, Lucentis, and Macugen for wet age-related macular degeneration, retinal vein occlusion, and diabetic macular edema are being administered in the United States at increasing rates. A 2010 study showed that in Canada and the incidence of injections grew 8 fold from 2005 to 2007 to 25.9 injections per 100,000 citizens. (Campbell 2010) In 2009, in the United States, over 1 million intravitreal injections were administered to Medicare beneficiaries. (Wykoff 2011) In the year 2011, the four doctors in my retina group administered a total of 6,494 intravitreal injections; in 2010, we administered 5021 intravitreal injections.
Even though intravitreal injections are commonly administered, the optimal method of anesthetizing the eye prior to injection has yet to be determined. Some physicians use an anesthetic drop, some a soaked cotton pledget, some use an anesthetic gel and some use subconjunctival injected anesthetic.
In 2009, the last time the Procedures and Trends Survey (PAT) (Mittra 2009) conducted by the American Society of Retina Specialists (the largest retina society in the world) asked about anesthetic methods for administering intravitreal injections, the following response was given by the 433 respondents:
- Topical anesthetic drop: 21.48%
- Topical viscous anesthetic: 23.33%
- Topical anesthetic & soaked cotton-tip or pledget: 29.79%
- Subconjunctival injection of anesthetic: 24.02%
- Other: 1.39%
An editorial in 2011 in the journal Retina, discusses the lack of good studies assessing optimal anesthetic prior to intravitreal injections. (Prenner 2011).
详细描述
Topical lidocaine gel with and without subconjunctival lidocaine injection for intravitreal injection: a within-patient study
Research Protocol
Steven M. Cohen, MD
1 & 2. General information including the rationale for the study. Explain the area of Current scientific concern and why the research is needed; Background information including a description of existing research and information that is already known on the topic; Since 2004, intravitreal injections of Avastin, Lucentis, and Macugen for wet age-related macular degeneration, retinal vein occlusion, and diabetic macular edema are being administered in the United States at an increasing rate. In Canada, the incidence of intravitreal injections grew 8 fold from 2005 to 2007 to 25.9 injections per 100,000 citizens. (Campbell 2010) In 2009, in the United States, over 1 million intravitreal injections were administered to Medicare beneficiaries. (Wykoff 2011) In the year 2011, the four doctors in my retina group administered a total of 6,494 intravitreal injections; in 2010, we administered 5021 intravitreal injections.
Even though intravitreal injections are commonly administered, the optimal method of anesthetizing the eye prior to injection has yet to be determined. Some physicians use an anesthetic drop, some use a soaked cotton pledget, some use an anesthetic gel and some use subconjunctival injected anesthetic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Patient receiving bilateral intravitreal injections
- •Ability to give informed consent
排除标准
- •Pre-existing eye pain
研究组 & 干预措施
Top Anesthesia 1 Eye SC Lidocaine 1 Eye
One eye:
Proparacaine Hydrochloride 0.5% Drop Tetravisc 0.5% Gel Acuvail Intra-vitreal Anti-VEGF Drug
Fellow Eye:
Proparacaine Hydrochloride 0.5% Drop Tetravisc 0.5% Gel Xylocaine 2% Injectable Anesthetic Acuvail Intra-vitreal Anti-VEGF Drug
干预措施: Xylocaine 2% Injectable Anesthetic (Procedure)
Top Anesthesia 1 Eye SC Lidocaine 1 Eye
One eye:
Proparacaine Hydrochloride 0.5% Drop Tetravisc 0.5% Gel Acuvail Intra-vitreal Anti-VEGF Drug
Fellow Eye:
Proparacaine Hydrochloride 0.5% Drop Tetravisc 0.5% Gel Xylocaine 2% Injectable Anesthetic Acuvail Intra-vitreal Anti-VEGF Drug
干预措施: Proparacaine Hydrochloride 0.5% Drop (Drug)
Top Anesthesia 1 Eye SC Lidocaine 1 Eye
One eye:
Proparacaine Hydrochloride 0.5% Drop Tetravisc 0.5% Gel Acuvail Intra-vitreal Anti-VEGF Drug
Fellow Eye:
Proparacaine Hydrochloride 0.5% Drop Tetravisc 0.5% Gel Xylocaine 2% Injectable Anesthetic Acuvail Intra-vitreal Anti-VEGF Drug
干预措施: Tetravisc 0.5% Gel (Drug)
Top Anesthesia 1 Eye SC Lidocaine 1 Eye
One eye:
Proparacaine Hydrochloride 0.5% Drop Tetravisc 0.5% Gel Acuvail Intra-vitreal Anti-VEGF Drug
Fellow Eye:
Proparacaine Hydrochloride 0.5% Drop Tetravisc 0.5% Gel Xylocaine 2% Injectable Anesthetic Acuvail Intra-vitreal Anti-VEGF Drug
干预措施: Acuvail (Drug)
Top Anesthesia 1 Eye SC Lidocaine 1 Eye
One eye:
Proparacaine Hydrochloride 0.5% Drop Tetravisc 0.5% Gel Acuvail Intra-vitreal Anti-VEGF Drug
Fellow Eye:
Proparacaine Hydrochloride 0.5% Drop Tetravisc 0.5% Gel Xylocaine 2% Injectable Anesthetic Acuvail Intra-vitreal Anti-VEGF Drug
干预措施: Intra-vitreal Anti-VEGF Drug (Drug)
结局指标
主要结局
Number of Participants Who Preferred Subconjunctival Anesthetic at the Third Follow-up Visit
时间窗: up to 6 months
Participants received anesthetic over several treatment visits. They were allowed to change there preference at each visit. The final outcome was the preference indicated at the third follow-up visit.
次要结局
- Number of Participatns With Level 10 Pain on Wong-Baker Pain Scale In Subconjunctival Eye At Time of Intravitreal Injection(24 hours)
- Likert Like Pain Scale Number of Participants Who Said the Topical Eye Hurt Much More Than the Subconjunctival Eye at Time of Intravitreal Injection(24 hours)
研究者
Steven Cohen, MD
Clinical Professor of Ophthalmology
Retina Vitreous Associates of Florida