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临床试验/NCT05569226
NCT05569226招募中不适用

OKKO Health Hyperacuity, Contrast and Colour Game Validation in Age-related Macular Degeneration

OKKO Health1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
Contrast sensitivity

研究概览

简要总结

Smartphone apps have the potential to measure standard metrics of visual function. In addition, new tests may serve as digital biomarkers to detect early progression of disease, assess risk of developing disease or expand the patient's clinical picture. Smartphones are inherently advantageous to reduce the reliance on specialist bulky and costly equipment that currently only exists in specialist clinics. While there are some smartphone apps available for vision monitoring, very few have any clinical evidence to support reliability, validity and diagnostic accuracy.

The OKKO Health app (www.okkohealth.com) is a smartphone app available on Apple iOS and Android platforms, consisting of short games with applied vision science technology to measure visual function in an engaging way. The app has one game per function, each on average 1-2 minutes. There are 4 game modes available testing visual acuity, contrast sensitivity, colour sensitivity and hyperacuity. This study will aim to validate these measures of visual function against gold standard clinical tests.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

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

  • Participants with AMD in at least one eye
  • Willing to travel to the clinic in Exmouth/Bristol
  • Able to hold and use a smartphone

排除标准

  • Significant ocular pathology other than AMD
  • Unable to provide written informed consent

结局指标

主要结局

Contrast sensitivity

时间窗: Day 1

Contrast sensitivity collected in the OKKO Health app and via Pelli Robson chart.

Colour sensitivity

时间窗: Day 1

Colour sensitivity collected in the OKKO Health app and via City University colour test/Mollon-Reffin colour vision test.

Visual acuity

时间窗: Day 1

Visual acuity collected in the OKKO Health app and via ETDRS chart

次要结局

  • Visual distortion(Day 1)
  • Optical coherence tomography (OCT)(Day 1)

研究者

发起方
OKKO Health
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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