Pain After Intravitreal Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Visual Analoge Scale
研究概览
简要总结
This randomized clinical trial is comparing two different needles (27 gauge versus 30 gauge) for intravitreal therapy (IVT). Standardized questionnaires and pain scales should allow for standard recommendation regarding the optimal needle size for IVT.
详细描述
Purpose: To evaluate the influence of the type of the needle on pain scores after intravitreal therapy (IVT).
Design: Randomized clinical trial Methods: A total of 200 patients, treated with an IVT for exudative age-related macular degeneration (AMD) or a vascular retinal disease, will be included and randomly assigned to be treated with either a 27-gauge needle (group 1) or a 30-gauge needle (group 2). After IVt the patient has to fill out a standardized questionnaire including pain scores on the visual analog scale after the surgical procedure.
Regression analysis of the scaled questionnaires should allow for a standard recommendation regarding the optimal needle size for minimal subjective pain during IVT.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 51 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •vitrearetinal disease including age-related macular degeneration,
- •clinical significant macular edema due to diabetic retinopathy or other vascular disorders
- •treatment with intravitreal therapy
排除标准
- •missing informed consent
- •age under 50 years
结局指标
主要结局
Visual Analoge Scale
时间窗: 1 day, after the intravitreal therapy (IVT)
pain scores on the visual analog scale after the IVT
次要结局
- Baker scale(1 day, after the intravitreal therapy (IVT))
- patients demographic data(1 day, record of patients data before or after intravitreal therapy (IVT))
研究者
Dr. Christiane I. Falkner-Radler
Principial investigator
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery