A Program to Develop Computerised Visual Function Tests for Cross Sectional Routine Clinical Practice and Long Term Monitoring to Detect Adverse Change in Visual Function.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 550
- 试验地点
- 1
- 主要终点
- Test-retest variability for the computerised vision measurement test and the gold standard hard copy test.
研究概览
简要总结
Clinical vision measurements usually involve printed charts with an eye care professional interpreting patient responses to generate a score. Those scores determine the need for or outcome of treatment. Detecting change can be improved with strict procedures/scoring, lending itself to computerisation. This in turn allows integration with electronic medical records. Many eye tests could be computerised in this way. At Guys and St Thomas' NHS Foundation Trust, the investigators have developed and validated a computerised test of distance visual acuity, called COMPlog which is now in widespread use. The investigators now want to increase the range of tests available.
There is also a need to longitudinally monitor for adverse change. Such monitoring must be developed to keep false positive and false negative change detection to a minimum.
The aims of this two year linked program are to:
Part A) validate an extended range of computerised vision measurement tests against their gold standard hard copy printed equivalents. Some of these tests are designed for use in children and all are meant to quantify both normal and impaired vision. Patients of all ages and visual function will therefore be recruited from St Thomas' Hospital. The specific tests we aim to validate are logMAR Letter Near Acuity, Word Near Acuity, Letter Contrast Sensitivity, Auckland Optotypes Picture Acuity, Low Contrast Letter Acuity, Stereoacuity and Vanishing Optotypes. Patients will undergo test-retest measurements with up to two of these.
Part B) Iteratively develop an application for use in home monitoring of subjects at risk of treatable vision loss due to age related macular degeneration.
All computerised tests in parts A and B will be performed on prototype software. Eye patients will be recruited as subjects. Patients recruited to part A will undergo tests on one day for up to an hour, subjects in part B will participate for between 1 hour and two months.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female patients attending hospital eye clinics, aged 3 - 99, inclusive.
- •Patients able to understand the information sheet, and willing and able to give informed consent to participate.
- •Patients with visual function ranging from normal to severely impaired.
- •Willing and able to comply with the visual function testing protocol.
- •Some validation studies require recruitment of disease specific groups (such as children with amblyopia or adults with age related macular degeneration).
- •For Part B of the project which aims to develop and pilot a home monitoring application, only adult (18-99 years) subjects complying with the above who also own a suitable browser device will be recruited.
排除标准
- •Unwilling or unable to comply with the visual function testing protocol.
- •Unwilling or unable to give informed consent.
- •Unwilling to participate.
- •In other research trials.
结局指标
主要结局
Test-retest variability for the computerised vision measurement test and the gold standard hard copy test.
时间窗: Through study completion, an average of 1 year
Measurement variability (difference in two measures captured using the same vision test on the same day) will be quantified in log units for each vision test used in this study.
Test agreement between the computerised vision measurement test and the gold standard hard copy test.
时间窗: Through study completion, an average of 1 year
The test agreement is quantified in terms of the mean difference and 95% confidence interval of the mean in log units.
次要结局
未报告次要终点