A Feasibility Study of Retinal Screening Using the RetinaVue 100 Hand- Held (Non-mydriatic) Camera in Outpatient Dialysis Centers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Usability of the RetinaVue Hand-Held 100 Camera
研究概览
简要总结
The purpose of this research study is to look at retinal abnormalities in outpatient renal dialysis patients using the FDA approved RetinaVue 100 hand-held (non-mydriatic) camera.
详细描述
There are no studies evaluating (diabetic or non-diabetic) retinopathy in the renal dialysis patient population (~300,000 Americans). Approximately 50% of this population has End-stage Retinal Disease (ESRD) due to diabetes. Dialysis patients are among the most debilitated patients, and thus, have even more barriers to receiving their recommended annual retinal evaluation. The advent of the RetinaVue hand-held retinal camera holds great promise in this population, as dialysis patients access medical care 3 times a week, for several hours at a time at their dialysis clinic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
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
- •The subject must currently be seeking treatment for end-stage renal disease (ESRD) at one of the specified dialysis clinics.
- •The subject must be ≥ 18 years of age.
排除标准
- •The subject is <18 years of age.
- •No exclusions will be made on the basis of gender, ethnicity, or race.
研究组 & 干预措施
RetinaVue 100 camera
Participants will have a retinal screening completed by study staff using the FDA-approved RetinaVue 100 hand-held camera
干预措施: RetinaVue 100 camera (Device)
结局指标
主要结局
Usability of the RetinaVue Hand-Held 100 Camera
时间窗: baseline visit
Usability of RetinaVue camera assessed by determining the number and percentage of inadequate images and the number and percentage of adequate images.
次要结局
- Pre-and Post-eye Exam Rates in the Diabetic Dialysis Population(Baseline and post retinal eye exam)
- Overall Retinopathy in a Dialysis Population(Post retinal eye exam)
- Participant Satisfaction(Post retinal eye exam)