Prospective Comparison of Technology-based Eye Care Services (TECS) With and Without OCT Assessment Versus Standard Face to Face Ophthalmologic Exam
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 256
- 试验地点
- 2
- 主要终点
- Number of patients with accurate diagnosis of eye diseases from TECS protocol versus face to face eye exam with and without OCT
研究概览
简要总结
The purpose of this study is to compare the Technology-based Eye Care Services (TECS) protocol to the standard face to face ophthalmologic exam.
详细描述
Patients will sign informed consent to enter the one visit study. They will undergo the study protocol and then see the face to face physician on the same day.
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
- •Patient at the Atlanta VA Medical Center (VAMC) New Comprehensive eye clinic
排除标准
- •Known acute or chronic ocular issues
研究组 & 干预措施
Face to face exam
Standard of clinical care, 8 point eye exam
干预措施: Technology-based Eye Care Services (TECS) Protocol (Other)
结局指标
主要结局
Number of patients with accurate diagnosis of eye diseases from TECS protocol versus face to face eye exam with and without OCT
时间窗: Evaluation Visit (Day 0)
Clinical diagnosis in dichotomous (yes/no) decision tree. The clinical diagnosis of the TECS protocol readers will be compared to the face to face physician, with the face to face serving as the standard of care. The results will be done with and without OCT. Sensitivity, specificity, positive and negative predictive value will be calculated before and after OCT.
次要结局
- Number of patients appropriately referred from the TECS protocol(Evaluation visit (Day 0))
- Number of participants with an accurate diagnosis for anterior segment disease(Evaluation visit (Day 0))
- Inter-reader variability of the TECS protocol(Evaluation visit (Day 0))
- Intra-reader variability of the TECS protocol(Evaluation visit (Day 0))
研究者
April Maa
Assistant Professor
Emory University