Evaluation of Different Frequency Doubling Technology (FDT) Mobile Devices for Visual Field Assessment
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Pattern of visual field loss in FDT visual fields as compared with standard HVF
研究概览
简要总结
This is a single center, prospective study to evaluate the efficacy and reproducibility of frequency doubling technology (FDT)-based visual field devices compared to conventional Humphrey Visual Field (HVF) perimetry. The investigators plan to enroll 500 patients in this study.
详细描述
Glaucoma is a leading cause of irreversible and preventable blindness world-wide. Insufficient evidence exists to support routine screening for glaucoma in a primary care setting due to the relatively low prevalence of the disease (Guirguis-Blake, 2005 and Moyer, 2013). Frequency doubling technology (FDT)-based perimetry is a relatively inexpensive and portable visual field testing device with a short testing time that has shown reasonable efficacy, sensitivity and specificity in screening for glaucoma in clinic- and community-based settings (Mansberger, 2005 and Nomoto 2009).
The aim of our study is to compare the efficacy and reproducibility of FDT perimetry platforms compared with Humphrey Visual Field (HVF) perimetry (which is the gold clinical standard in clinics and hospitals) in detecting glaucomatous visual field defects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Adult patients (18 and over) who speak English, Spanish or Creole, and are capable of providing informed consent and who have a Humphrey Visual Field (HVF) test within the prior the 6 months preceding enrollment are eligible for enrollment in this non-invasive study. Patients will be recruited from among patients at the Bascom Palmer Eye Institute clinics during their regularly scheduled clinic visits. No advertising will be used to recruit patients.
排除标准
- •Adults unable to consent, individuals who are not yet adults (infants, children and teenagers), pregnant women and prisoners and other vulnerable populations will be excluded from the study.
结局指标
主要结局
Pattern of visual field loss in FDT visual fields as compared with standard HVF
时间窗: The investigators anticipate to enroll the subjects over a period of 12 months. The estimated time required for data analysis is 6 months following enrollment of all subjects.
Visual Field
次要结局
- Mean deviation (MD) in FDT visual fields as compared with standard HVF(The investigators anticipate to enroll the subjects over a period of 12 months. The estimated time required for data analysis is 6 months following enrollment of all subjects.)
- Pattern standard deviation (PSD) in FDT visual fields as compared with standard HVF(The investigators anticipate to enroll the subjects over a period of 12 months. The estimated time required for data analysis is 6 months following enrollment of all subjects.)
研究者
Richard K. Lee
Associate Professor of Ophthalmology, Cell Biology and Neuroscience Graduate Program
University of Miami