The Role of Loteprednol in Reducing Post-Intravitreal Injection Related Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Post-Intravitreal Injection Pain
研究概览
简要总结
Patients are already receiving an intravitreal injection as a standard of care, but they are consenting to receiving a loteprednol drop following the intravitreal injection. This clinical trial is studying the role of loteprednol (corticosteroid) in reducing pain following intravitreal injections for patients with age-related macular degeneration. As of now, there is no definitive pain management technique following intravitreal injections. Loteprednol is a corticosteroid widely used in ophthalmology to treat pain and inflammation, however, it has not been studied as a treatment for pain following intravitreal injections. Our overall goal is to manage pain to improve quality of care after intravitreal injections. Participants will be given either loteprednol, or artificial tears following one visit for an intravitreal injection to test how effective loteprednol is in pain reduction. Pain levels will be assessed by asking participants over the phone about their pain from a scale of 0 to 10 at three different times over a 1-week period. Artificial tear and medication usage will also be tracked over a 1-week period.
详细描述
Patients are already receiving an intravitreal injection as a standard of care for age-related macular degeneration, but they are consenting to receiving a loteprednol drop following the intravitreal injection for the research study. Loteprednol is used as a part of regular medical care at the Vistar Eye Center following intravitreal injections but quantifying the magnitude of pain reduction has not been done yet. Additionally, as of now there is no definitive pain management technique following intravitreal injections. This clinical trial is studying the role of loteprednol (corticosteroid) in reducing pain following intravitreal injections for patients with age-related macular degeneration. Participants will be treated with either loteprednol, or artificial tears following one visit for an intravitreal injection at the Vistar Eye Center to test how effective loteprednol is in pain reduction. Pain levels will be assessed by asking participants over the phone about their pain from a scale of 0 to 10 at 2-hours, 1-day, and 1-week following the intravitreal injection. Intravitreal injections will be performed by the retina surgeon, and phone calls will be done with the research coordinator. Artificial tear and medication usage will also be tracked over a 1-week period.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The study design is a double-blinded placebo-controlled experiment, as the patient and the investigator recording the pain scores will not know which treatment arm the patient is assigned to (negative control or experimental group).
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
- •All patients must have age-related macular degeneration and be undergoing intravitreal injections for treatment as defined by a retina specialist.
排除标准
- •Report baseline eye pain
- •Use topical NSAIDs or steroids
- •Patient under 18 years old
- •History of corticosteroid responsive elevation in intraocular pressure
- •Allergy to Loteprednol or Nepafenac
- •Pre-existing chronic pain disorders
- •Advanced Glaucoma
- •Herpes zoster
- •Allergy to local anesthetic or penicillin
- •Patients unable to consent on own behalf
- •Patients unable to communicate pain
- •Pregnancy
- •Incarceration
研究组 & 干预措施
Loteprednol
1 drop of Loteprednol is administered immediately after the intravitreal injection in this treatment arm.
干预措施: Loteprednol Etabonate Ophthalmic Gel [Lotemax] (Drug)
Artificial tears
1 drop of artificial tears is administered immediately after the intravitreal injection in this treatment arm. This arm acts as a negative control.
干预措施: Refresh Lubricant Eye Drops [Artificial Tears] (Other)
结局指标
主要结局
Post-Intravitreal Injection Pain
时间窗: 1-week Post-Intravitreal Injection
11-point Numerical Rating Scale (0-10, 0 being the lowest level of pain and 10 being highest level of pain)
次要结局
- Analgesic Medication Use(1-week Post-Intravitreal Injection)
- Artificial Tear Use(1-week Post-Intravitreal Injection)
研究者
Vishak John
Retina Surgeon
Virginia Polytechnic Institute and State University