Low Dose Fluorescein Angiography Comparing 1mL and 3mL of 10% Fluorescein: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Subjective image quality from 3 experts
研究概览
简要总结
This study aims to compare the efficacy and safety of fluorescein angiography using 1mL versus 3mL of 10% fluorescein dye.
详细描述
The investigators will recruit patients who need fluorescein angiography for their retinal diseases.
The investigators will collect data on image quality and complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who required an fluorescein angiography for their retinal diseases (eg. diabetic retinopathy, retinal vein occlusion, etc.)
排除标准
- •media opacity (corneal opacity, vitreous hemorrhage grade 2 or more, cataract LOCS III grade 3 or more)
- •known history of adverse reactions to fluorescein
- •dilated pupil diameter less than 5 mm
研究组 & 干预措施
Na Fluorescein 3mL Arm
Participants in this arm will receive Na Fluorescein 10% Inj 3mL (300mg) before taking fluorescein angiography.
干预措施: Fluorescein Sodium (Drug)
Na Fluorescein 1mL Arm
Participants in this arm will receive Na Fluorescein 10% Inj 1mL (100mg) before taking fluorescein angiography.
干预措施: Fluorescein Sodium (Drug)
结局指标
主要结局
Subjective image quality from 3 experts
时间窗: One month
Images from two dose groups will be compared in terms of central and peripheral image quality. Three retinal experts were masked to the fluorescein dose the patients had received. Each expert graded patients' fluorescein angiography images on a scale of 1 to 5 (1:very poor, 2: poor, 3: average, 4: better than average, 5: excellent) with respect to the subjective quality of the image and aid of making a diagnosis. The mean value of the image quality score will be compared between the two dose groups.
次要结局
- Complication(immediately after the test)
- Objective vessel intensity(One month)
研究者
Min Seok Kim
Professor
Seoul National University Bundang Hospital