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临床试验/NCT03270865
NCT03270865已完成不适用

Usability and Ergonomic Evaluation of Self-Positioning System for Retinal Imaging

Notal Vision Ltd.1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2017年9月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
1
主要终点
spatial location of the pupil, during an eye examination

研究概览

简要总结

The purpose of the study "Usability and Ergonomic Evaluation of Self-Positioning System for Retinal Imaging" is to enable self-operation of a monitoring device in home-simulated environment

详细描述

One of the main challenges in developing a retinal imager is to design it to be self-operated by elderly patients in their home setting The study's objective is to explore ergonomic solutions that will allow the user to perform imaging on their own. The study will be done in a home-simulated environment using a dedicated ergonomic system (termed "PAF" - Positioning And Fixation system) that stimulates the retinal imager and enables to record the tested subject using standard cameras. The prototype doesn't include the retinal imager and does not include any imaging capabilities aside from standard means of photography Subjects will be evaluating for positioning accuracy and comfort by comparing different methods. Pupil position will be recorded using commercial off the shelf cameras when the subject is performing simple ergonomic tasks while looking at a screen presenting images.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Able to understand and sign the informed consent form
  • •Ability to communicate verbally
  • •AMD (interim and advanced) or diabetic retinopathy (with and without DME)

排除标准

  • •Visual acuity >=20/200 in the better eye

研究组 & 干预措施

Usability and Ergonomic Evaluation of Self-Positioning System

Experimental

干预措施: PAF (Positioning And Fixation device) (Device)

结局指标

主要结局

spatial location of the pupil, during an eye examination

时间窗: 1 year

documentation of pupil location by a camera

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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