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临床试验/NCT01701700
NCT01701700已完成不适用

The Effectiveness of Portable Electronic Vision Enhancement Systems (EVES) in Comparison to Optical Magnifiers for Near Vision Activities in Visual Impairment - The p-EVES Study

Manchester University NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年2月最近更新:
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
100
试验地点
2
主要终点
usage of magnifiers

研究概览

简要总结

Over 1 million people in the UK suffer from untreatable visual impairment, many of them elderly. The major complaint of visually impaired people is their inability to carry out simple tasks, especially those involving reading. It is known that this activity limitation is a major cause of depression in an older population, and it is reflected in reduced quality of life. Low vision clinics, mostly based within hospital ophthalmology departments, dispense optical magnifiers to allow patients to carry out these tasks again, but these devices do have limitations (unusual posture, short working distance, monocular viewing). Although electronic magnifiers have been around since the 1960s, they were initially very large and expensive. Recent advances in technology have brought about an explosion in the number and range of portable and moderately-priced aids, which can be used binocularly, in a natural working position: these are currently not available through the NHS. Evidence is needed as to whether these portable hand-held electronic magnifiers could offer a significant benefit to the majority of patients, and therefore whether they should be routinely dispensed in low vision clinics.

The proposed study is a two-arm randomised crossover trial with existing users of optical magnifiers being assigned to use a hand-held electronic magnifier in addition to their existing devices for 2 months. Reading and task performance will be measured with the aid, and compared to the performance with optical aids, and the patient will be asked to report on the comparisons between the aids.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients of Manchester Royal Eye Hospital
  • Visual impairment secondary to range of stable ocular pathologies (no change in VA > 2 lines in previous 6 months)
  • Currently possess a near vision optical magnifying device.
  • VA <= 6/30 (<=0.7 logMAR) and/or log contrast sensitivity <=1.20

排除标准

  • Current use of personal EVES device
  • Hearing inadequate to respond to verbal instruction
  • Habitual language not English
  • A physical disability preventing the participant from operating the device
  • A score of less than 19 on the Mini-Mental State Examination

研究组 & 干预措施

portable electronic magnifier

Experimental

Use of a prescribed electronic magnifier plus existing optical aids for a period of 2 months

干预措施: portable electronic magnifier (Procedure)

portable electronic magnifier

Experimental

Use of a prescribed electronic magnifier plus existing optical aids for a period of 2 months

干预措施: optical aids (Procedure)

optical aids

Active Comparator

Use of existing optical aids for 2 months

干预措施: optical aids (Procedure)

结局指标

主要结局

usage of magnifiers

时间窗: Change from baseline at 2 months and 4 months

Use of Manchester Low Vision Questionnaire to quantify device usage

reading speed

时间窗: Change from baseline at 2 months and 4 months

Reading speed using the device assessed by MNREAD test

次要结局

  • difficulty with near vision activities(Change from baseline at 2 months and 4 months)
  • health related quality of life(Change from baseline at 2 months and 4 months)
  • speed of performance of activities of daily living(Change from baseline at 2 months and 4 months)
  • well-being(Change from baseline at 2 months and 4 months)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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