Intravitreal Injection Using 33-gauge Versus 30-gauge Needles: Comparison of Patients' Experience
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Difference in discomfort between 30g and 33g needle
研究概览
简要总结
We are comparing the patient experience between the standard 30 g needle to the smaller 33 g needle for intravitreal injections of ranabizumab or aflibercept for age related macular degeneration, diabetic macular edema, or retina vein occlusions.
详细描述
This is a prospective, randomized, interventional pilot study, which seeks to compare the patient experience using 30-gauge versus 33-gauge needle for bilateral same-day intravitreal injections of ranibizumab or aflibercept for the treatment of wet age-related macular degeneration (AMD), diabetic macular edema (DME), or macular edema associated with retinal vein occlusion (RVO). The null hypothesis is that there is no difference in patient discomfort or pain with the 30-gauge needle compared to the 33-gauge needle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Patients undergoing bilateral, same-day, intravitreal injections of either ranibizumab oraflibercept for the diagnosis of wet AMD, DME, or RVO-associated macular edema
排除标准
- •Patients who do not receive Betadine ophthalmic solution prior to intravitreal injection due to documented allergy 2) Patients who are receiving intravitreal bevacizumab (this medication iscompounded into pre-filled 1-mL tuberculin syringes).
研究组 & 干预措施
33 g needle - right eye
33 g needle for intravitreal injection of Lucentis or Eylea for right eye and 30 g needle for left eye
干预措施: Varying needle size with intravitreal ranibizumab or aflibercept (Procedure)
33 g needle - left eye
33 g needle for intravitreal injection of Lucentis or Eylea for left eye and 30 g needle for right eye
干预措施: Varying needle size with intravitreal ranibizumab or aflibercept (Procedure)
结局指标
主要结局
Difference in discomfort between 30g and 33g needle
时间窗: Day 1
Intravitreal injection study pain questionnaire to evaluate discomfort associated with intravitreal injections
次要结局
- Intraocular pressure 5 minutes post injection(Day 1)
研究者
MidAtlantic Retina
Allen Chiang, MD
Wills Eye