跳至主要内容
临床试验/NCT03919708
NCT03919708撤回不适用

Deploying Retinal Birefringence Imaging in to the Clinic for Pediatric Vision Screening

Rebiscan, Inc.1 个研究点 分布在 1 个国家开始时间: 2020年2月4日最近更新:
适应症

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

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

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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