Crossland Michael D, Thomas Rachel, Unwin Hilary, Bharani Seelam, Gothwal Vijaya K, Quartilho Ana, Bunce Catey, Dahlmann-Noor Annegret
Optometry, Moorfields Eye Hospital, London, UK.
Optometry, Moorfields Eye Hospital at Bedford Hospital, Bedford, UK.
BMJ Open. 2017 Jun 21;7(6):e015939. doi: 10.1136/bmjopen-2017-015939.
Low vision and blindness adversely affect education and independence of children and young people. New 'assistive' technologies such as tablet computers can display text in enlarged font, read text out to the user, allow speech input and conversion into typed text, offer document and spreadsheet processing and give access to wide sources of information such as the internet. Research on these devices in low vision has been limited to case series.
We will carry out a pilot randomised controlled trial (RCT) to assess the feasibility of a full RCT of assistive technologies for children/young people with low vision. We will recruit 40 students age 10-18 years in India and the UK, whom we will randomise 1:1 into two parallel groups. The active intervention will be Apple iPads; the control arm will be the local standard low-vision aid care. Primary outcomes will be acceptance/usage, accessibility of the device and trial feasibility measures (time to recruit children, lost to follow-up). Exploratory outcomes will be validated measures of vision-related quality of life for children/young people as well as validated measures of reading and educational outcomes. In addition, we will carry out semistructured interviews with the participants and their teachers.
NRES reference 15/NS/0068; dissemination is planned via healthcare and education sector conferences and publications, as well as via patient support organisations.
NCT02798848; IRAS ID 179658, UCL reference 15/0570.
低视力和失明对儿童及青少年的教育和独立性产生不利影响。诸如平板电脑等新型“辅助”技术能够以放大字体显示文本、为用户朗读文本、实现语音输入并转换为打字文本、进行文档和电子表格处理,还能访问诸如互联网等广泛的信息来源。针对低视力人群对这些设备的研究仅限于病例系列。
我们将开展一项试点随机对照试验(RCT),以评估针对低视力儿童/青少年进行辅助技术全面RCT的可行性。我们将在印度和英国招募40名年龄在10至18岁之间的学生,并将他们以1:1的比例随机分为两个平行组。积极干预措施将是苹果iPad;对照组将采用当地标准的低视力辅助护理。主要结局将是设备的接受度/使用率、可及性以及试验可行性指标(招募儿童的时间、失访情况)。探索性结局将是针对儿童/青少年视力相关生活质量的经过验证的指标,以及阅读和教育结局的经过验证的指标。此外,我们将对参与者及其教师进行半结构化访谈。
国家研究伦理服务体系(NRES)编号15/NS/0068;计划通过医疗保健和教育部门会议及出版物,以及患者支持组织进行传播。
NCT02798848;国际认可研究注册(IRAS)编号179658,伦敦大学学院(UCL)编号15/0570。