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临床试验/NCT02526680
NCT02526680已完成不适用

The Impact of a Novel Artificial Vision Device (OrCam) on the Quality of Life of Patients With Advanced Glaucoma

Wills Eye2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2014年5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
发起方
入组人数
27
试验地点
2
主要终点
Impact of OrCam on Vision-related Quality of Life

研究概览

简要总结

To determine the impact of OrCam over 1 month on health-related quality of life (HRQoL) in subjects with advanced glaucoma using the National Eye Institute Visual Function Questionnaire 25 (NEI-VFQ-25).

To identify tasks for which subjects are using the OrCam device and patient satisfaction.

详细描述

Participants will document their daily impression about the use of OrCam, a small camera attached to their glasses over a 1-month period. They will attend 2 appointments at Wills Eye Hospital Glaucoma Research Center (baseline and final visit). Participant's will be trained to use the OrCam device at baseline visit and complete a best-corrected visual acuity assessment ETDRS (early treatment diabetic retinopathy study) and the NEI-VFQ-25 questionnaire. They will also read a short newspaper article.

The NEI-VFQ-25 includes a series of 25 questions pertaining to vision or feelings about a vision condition. Answers are selected among a numbered list of possible responses, the values of which are ultimately recoded and converted to a 0 to 100 scale. Items within each subscale are averaged together to create 12 subscale scores. An overall composite score will be calculated by averaging vision-targeted subscale scores, excluding the general health rating question.

Participants will read a short article. They will be asked to grade their reading difficulty between 1 (unable to read) to 10 (able to read without difficulty). Time to read article will be recorded. Reading task will be performed with best correction - with and without the assistance of the OrCam device.

Subjects will utilize OrCam daily for one month. Each week, subjects will record thoughts about the device in a log book or by using audio tape recorder, according to patient's personal preference.

Final assessment at 1 month will include best-corrected visual acuity (ETDRS), NEI-VFQ-25, and the newspaper-reading task with and without OrCam assistance. A satisfaction questionnaire will be completed in order to assess subjects' overall feelings regarding OrCam. Audio log books will be analyzed for specific factors and recorded by a research assistant.

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

  • Glaucoma any type, characterized by glaucomatous optic neuropathy and corresponding visual field (VF) defect
  • Visual acuity of 20/400 to hand motion (HM) in better eye or visual field less than 10 degrees in better eye and having difficulty reading.
  • Age 18 years or older
  • Able to understand and speak English
  • Able to use an electronic recording device
  • Able to operate a computerized system

排除标准

  • Neurological or musculoskeletal problems that would influence performance on activities of daily living
  • Incisional eye surgery within past three months
  • Laser therapy within previous month
  • Any cause for visual impairment other than glaucoma
  • Photophobia
  • Any medical condition precluding subject from providing reliable, valid data

研究组 & 干预措施

Glaucoma Subjects

Experimental

27 glaucoma subjects will be given the OrCam low vision aid device to use for 1 month.

干预措施: OrCam (Device)

结局指标

主要结局

Impact of OrCam on Vision-related Quality of Life

时间窗: 1 month

National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) is a series of questions pertaining to vision or feelings about a vision condition in relation to functional status to assess their quality of life. Multiple choice responses from 12 subscales (general vision, near vision, distance vision, ocular pain, social functioning, mental health, roll difficulties, dependency, driving, color vision and peripheral vision) were recorded into a 0-100 score where 0 represents the lowest perceived vision difficulties and 100 the highest perceived difficulties. NEI-VFQ-25 was used to measure the number of participants who showed improvement in vision-related quality of life after using the OrCam device over a one month period.

次要结局

  • Impact of OrCam on Reading Newspapers(1 month)
  • Recommending OrCam to Others(1 month)
  • Impact of OrCam on Grocery Shopping(1 month)

研究者

发起方
Wills Eye
申办方类型
Other
责任方
Principal Investigator
主要研究者

L. Jay Katz MD

Principal Investigator

Wills Eye

研究点 (2)

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