Exploring the Feasibility of the OKKO Health App to Monitor and Predict the Decline in Vision Caused by Age-related Macular Degeneration
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Change in visual status
研究概览
简要总结
Macular disease is the leading cause of blindness in the UK and age-related macular degeneration must undergo monitoring to determine if an injection into the eye is required that month [required in 50% of visits] - these patients are the 'frequent fliers' within ophthalmology units, visiting specialist hospital clinics on a monthly or bi-monthly basis. This project aims to create a home-monitoring algorithm that could in the future, enable the movement of 'monitoring' of chronic eye disease into the patients' homes: remotely identifying who does need an in-person appointment, and who can safely stay away from hospital.
详细描述
The OKKO Health application is a CE-marked medical software application that aims to monitor visual function, track symptoms and treatment, and improve patient knowledge about their condition.
To monitor visual function, OKKO implements quick and engaging activities to assess visual function, contrast sensitivity, and hyperacuity. The aim of this is to develop the app to see if it is possible to detect changes in visual function in a timely manner. This would enable regular monitoring for disease progression and/or the response of visual function to treatments between clinical visits. Home monitoring may reveal information that may support the early diagnosis of worsening conditions and may enable a greater understanding of disease progression or stabilisation. Currently unpublished data collected using the OKKO Health app highlights its acceptability when collecting visual acuity compared to gold standard techniques used in clinical practice.
OKKO includes self-monitoring features which may result in an increased (disease) awareness including vision changes between clinic visits. OKKO offers symptom and treatment tracking functionality as well as education modules to increase literacy about the disease and treatment. These elements may improve the patient's self-efficacy, enable patient empowerment, and may increase the involvement of patients in their care and more thorough communication with ophthalmologists including shared decision-making processes. Thus, these psychological and behavioural changes may alleviate the patient's burden.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients newly diagnosed with wet (neovascular) AMD in at least on eye at the start of their anti-VGEF treatment.
- •Participants with wet AMD in at least one eye undergoing anti-VGEF therapy.
- •Access to a device running a compatible software
- •Apple device running iOS 12 or later,
- •Android devices running Android 7.0 or later,
- •Ability to read and understand English.
- •Willing and able to provide informed consent.
排除标准
- •Vision worse than 6/60 or 1.0 LogMAR in both eyes.
- •Significant cognitive impairment.
- •Patients who do not have the manual dexterity to tap a screen.
结局指标
主要结局
Change in visual status
时间窗: 12 months continuous use
Generate an algorithm to detect a change in visual status (in particular a deterioration) in advance of in-person hospital appointment.
次要结局
- Impact of the OKKO Health app on Health literacy(3-6 months of app use)
- Patient engagement with OKKO Health app(12 months continuous use)
- To explore the correlation of varying demographic and lifestyle factors on AMD disease progression(12 months continuous use)