跳至主要内容
临床试验/NCT03353727
NCT03353727终止不适用

Orthoptic Rehabilitation for Low Vision People With Innovative Mechanisms (Eye Tracker and Tactile Device)

Fondation Ophtalmologique Adolphe de Rothschild6 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2017年6月20日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
12
试验地点
6
主要终点
score assessing the feasibility of the rehabilitation

研究概览

简要总结

This project is working on orthoptic rehabilitation for low vision people. The aim of the project is to assess the interest and integration of this rehabilitation device used at home, in low-vision private practice and at the hospital. It leads to develop and evaluate an innovative device to integrate and adjust monitoring of patients according to their need and their progress, to create new interactions with the patient, enabling the orthoptist to stay in touch with his patient at home between rehabilitation sessions and to obtain a more fine and objective analysis of the exercises done by the patient.

Using an eye tracker and a digital tactile screen with data uploads allows the practitioner to observe the progress objectively. It also leads the patient to a better understanding of his/her visual behavior and of the effects of rehabilitation. Therefore, it will be easier to adopt better strategies.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients suffering from visual impairment, with a need for visual rehabilitation
  • Visual acuity (≤1.3 logMAR)
  • Good knowledge of French language
  • Informed consent of research

排除标准

  • Medical treatment that may interfere with the study
  • Degenerative diseases or any other diseases that may interfere with the study.
  • Mini-Mental State Examination Score without visual item ≤ 20/25
  • Pregnancy and lactation.

结局指标

主要结局

score assessing the feasibility of the rehabilitation

时间窗: 18 months after inclusion

System Usability Scale score

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Sponsor

研究点 (6)

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