Pain Control Following Intravitreal Injection Using Topical Nepefanac 0.3% or Pressure Patching: A Prospective, Randomized, Placebo Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Post Intravitreal Injection Measurement of Pain
研究概览
简要总结
A prospective randomized trial, to evaluate post-injection comfort measures comparing topical NSAID (nepafenac 0.3% suspension) and patching.
详细描述
This is a single masked, randomized, placebo-controlled study that will enroll approximately 60 subjects with recent active retina related disease requiring intravitreal agents. Subjects will be randomized into one of 3 groups in a 1:1:1 ratio, and assigned to receive nepafenac 0.3% suspension or a sham procedure. Subjects will have a one in three (33%) chance of receiving active treatment (no sham procedure), a one in three (33%) chance of receiving patching procedure (no active treatment) or a one in three (33%) chance of receiving placebo (no active treatment).
Study participants will then complete the Visual Analog Scale immediately following injection and then after 1 hour, and, 24 hours. The VAS data along with relevant data related to each subject's injection will also be compiled, including, but not limited to: drug injected, diagnosis, co-morbid conditions, history of previous injections, visual acuity, age, and gender.
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
- Double (Participant, Outcomes Assessor)
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
- •18 years of age or older
- •Already scheduled for anti-VEGF injection based on standard of care for disease process.
- •Ability to provide written informed consent
- •Capable of complying with study protocol.
- •Volunteer written informed consent with the understanding that consent may be withdrawn by the subject at any time without prejudice to future care
排除标准
- •History of past intraocular injection of steroid medication.
- •Experiencing baseline eye pain
- •Monocular; non-study eye with VA<20/
- •Unwilling or unable to follow or comply with all study related procedures
研究组 & 干预措施
A single drop of nepafenac 0.3% suspension
A single drop of nepafenac 0.3% suspension (Ilevro; Alcon, Fort Worth, TX)
干预措施: nepafenac 0.3% suspension (Ilevro; Alcon, Fort Worth, TX) (Drug)
Patching
A light pressure patch applied for two hours
干预措施: patching (Other)
A single drop of preservative-free Artificial Tears
A single drop of preservative-free Theratears tear drop, (Akron, Ann Arbor, MI).
干预措施: Theratears tear drop, (Akron, Ann 111 Arbor, MI) (Drug)
结局指标
主要结局
Post Intravitreal Injection Measurement of Pain
时间窗: 6 hours and 24 hours after intravitreal injection
Change from Baseline post intravitreal injection pain at 6 and 24 hours as measured by the Numeric Pain Rating Scale. The pain numeric rating scale (NRS), on which patients rate their current pain intensity from 0 ("no pain") to 10 ("worst possible pain"), at the screening, 6 hours and 24 hours.
次要结局
未报告次要终点
研究者
Ronald Gentile, MD
Professor
The New York Eye & Ear Infirmary