Deploying Retinal Birefringence Imaging in to the Clinic for Pediatric Vision Screening
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Presence of amblyopia / strabismus
研究概览
简要总结
The purpose of this project is to compare the accuracy of two products at detecting amblyopia and strabismus in children. The devices will be Rebiscan's "blinq" (Pediatric Vision Scanner; PVS) and Rebiscan's RBI (Retinal Birefringence Imager).
详细描述
Rebiscan is proposing a two-cohort study. The first cohort will include a population enriched for pathology in amblyopia to best assess device sensitivity, while a second cohort will be based in a primary care setting to best assess device specificity. The study will be conducted in busy, ethnically and economically diverse cites affiliated with the Retina Foundation of the Southwest (RFSW) in greater Dallas, TX area. Each child will be screened with Rebiscan's RBI device and it's PVS device in sequence, with results compared to the PVS as well as a comprehensive ophthalmic examination performed by a certified pediatric ophthalmologist in a statistically appropriate subset of screened subjects. Testing times will be assessed to compare the efficiency of the PVS and the RBI screening experiences. The percentage of children successfully completing the screening process will also be measured.
The RBI is expected to identify children with amblyopia and strabismus, without referring children who will not benefit from early treatment
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 8 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children who present to the participating clinics
- •Provide assent
- •Guardian provides informed consent
排除标准
- •Developmental delay or cognitive deficit
结局指标
主要结局
Presence of amblyopia / strabismus
时间窗: 1 single day
Readouts of RBI device will be compared to clinical examination results
次要结局
未报告次要终点
