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临床试验/NCT02614651
NCT02614651
已完成
不适用

Prospective Pilot Study on the Quantitative Evaluation of Vision Parameters Needed by Virtual Reality Goggle Displays for Subjects With Concentric Visual Field Constriction. AUgmented REality for the Visually Impaired - Part 1

Centre Hospitalier Universitaire de Nīmes1 个研究点 分布在 1 个国家目标入组 15 人2016年5月

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Retinitis Pigmentosa
发起方
Centre Hospitalier Universitaire de Nīmes
入组人数
15
试验地点
1
主要终点
The maximum brightness value for visual comfort (THRESHOLD_MAX)
状态
已完成
最后更新
8年前

概览

简要总结

The main objective of this study is to quantify vision parameters in subjects with concentric visual field constriction, and this in relation to the display on virtual reality goggles. More specifically:

  • The maximum brightness value for visual comfort (THRESHOLD_MAX)
  • The minimum value of the perceptible light contrast in low light perceptible (THRESHOLD_MIN)
  • The speed of light change adaptation in the range [THRESHOLD_MAX-THRESHOLD_MIN] and [THRESHOLD_MIN-THRESHOLD_MAX].

详细描述

Secondary objectives are to: A. Quantifying the device parameters "RV glasses + camera" depending on visual acuity and the visual field of each subject: * Optimal extent of the visual field provided by the device "RV glasses + camera". B. Measuring the effectiveness of different image processing algorithms used in the development of the software part of this technical assist device: * Capture and display HDR images (High Dynamic Range) * Color adjustment.

注册库
clinicaltrials.gov
开始日期
2016年5月
结束日期
2017年5月29日
最后更新
8年前
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

发起方
Centre Hospitalier Universitaire de Nīmes
责任方
Sponsor

入排标准

入选标准

  • The patient must have given his/her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • The subject is suffering from retinitis pigmentosa or glaucoma with concentric visual field constriction and presents with:
  • An acuity in the better eye superior or equal to 1/10 in near vision,
  • A binocular field of between 1° and 30°,
  • A good central fixation, absence of central scotoma,
  • Motor capability for using a computer keyboard with one hand.

排除标准

  • The patient is participating in another study
  • The patient is in an exclusion period determined by a previous study
  • The patient is under judicial protection, or under guardianship
  • The patient refuses to sign the consent
  • It is impossible to correctly inform the patient
  • Subjects with (or evolving toward) a multiple sensory disability, or one including cognitive disorders

结局指标

主要结局

The maximum brightness value for visual comfort (THRESHOLD_MAX)

时间窗: 0 to 6 months

The minimum value of the perceptible light contrast in low light perceptible (THRESHOLD_MIN)

时间窗: 0 to 6 months

The speed of light change adaptation within a pre-specified range (getting dimmer)

时间窗: 0 to 6 months

The pre-specified range goes from THRESHOLD_MAX down to THRESHOLD_MIN.

The speed of light change adaptation within a pre-specified range (getting brighter)

时间窗: 0 to 6 months

The pre-specified range goes from THRESHOLD_MIN up to THRESHOLD_MAX.

次要结局

  • Optimal range (in degrees) of the visual field provided by the device "RV glasses + camera"(0 to 6 months)
  • Response time in seconds(0 to 6 months)
  • Number of correct responses(0 to 6 months)

研究点 (1)

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