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临床试验/NCT02829606
NCT02829606已完成不适用

Head Mounted Eye Tracking Aide for Loss of Central Vision

University of Minnesota1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2016年4月1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
8
试验地点
1
主要终点
Reading speed

研究概览

简要总结

A device has been developed that has eye trackers integrated within the Head Mounted Display (HMD) and can remap text and images around the scotoma in real time to prevent information loss from a central scotoma. It can also carry out other types of image processing such as contrast enhancement and image magnification. The aim of this study is to assess the efficacy of this device on the visual performance of participants suffering from central vision loss, with and without remapping

详细描述

Participants with bilateral central scotomas will be selected for this study during their routine clinical visits at the University of Minnesota Eye Clinic. Written consent will be obtained from all participants.

Each participant will have their scotomas mapped using a Nidek MP-1 microperimeter housed in the psychology department to give exact size and shape information. This allows for the extent of each eye's scotoma to be put into the remapping software, and their intersection used in remapping calculation. Comparisons will be made between participants with small scotoma, less than 5 degrees, and participants with large scotoma, larger than 5 degrees. Experiments to be performed with the device are also divided into two categories. Category 1 involves reading of naturalistic text, and everyday task performance. Category 2 involves studying the effects of practice with the device on performance in category 1 experiments.

Participants will schedule an initial one-hour session for testing. During testing, participants will be told about the device and its functionality. Main instructions include what patients can expect to experience and see when wearing the HMD. Following this, the participants will be instructed on how to wear the HMD. If they have any glasses/ corrective lenses, they can be kept on. Once the patients don the HMD, testing will begin.

Initially, a calibration-free mode will be tested. This will entail asking the subject to focus on a particular point on the screen and checking if the gaze point determined by the eye tracker corresponds to this point. If good calibration is obtained, the investigators proceed with testing. Otherwise, a 3-point calibration sequence will be initiated following instructions on the software program. For the 3-point calibration sequence, the participant will be instructed to fixate at 3-5 different points on the screen one at a time. Following this calibration sequence, testing will resume and visual performance such as reading speed in words/minute will be measured as the primary outcome measure, with and without remapping.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
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
否

入选标准

  • •18 years or older
  • •Central vision loss from bilateral central scotomas
  • •No cognitive impairment as indicated by a Mini-Mental State Examination (MMSE)

排除标准

  • •Failed MMSE

研究组 & 干预措施

small scotoma using Head Mounted Display No re-mapping

Active Comparator

patients with scotoma smaller than 5 degrees NO re-mapping PLUS re-mapping

干预措施: small scotoma using Head Mounted Display No re-mapping (Other)

small scotoma using Head Mounted Display No re-mapping

Active Comparator

patients with scotoma smaller than 5 degrees NO re-mapping PLUS re-mapping

干预措施: Large scotoma using Head Mounted Display PLUS re-mapping (Other)

Large scotoma using Head Mounted Display PLUS re-mapping

Active Comparator

patients with scotoma larger than 5 degrees NO re-mapping PLUS re-mapping

干预措施: small scotoma using Head Mounted Display No re-mapping (Other)

Large scotoma using Head Mounted Display PLUS re-mapping

Active Comparator

patients with scotoma larger than 5 degrees NO re-mapping PLUS re-mapping

干预措施: Large scotoma using Head Mounted Display PLUS re-mapping (Other)

结局指标

主要结局

Reading speed

时间窗: 5 years

words/minute

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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