User-centric Study of Patients' Receptiveness Towards the Web-based Automated Vision Impairment Gaze-tracking Analysis Systems
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Assess System Usability
研究概览
简要总结
Age-Related Macular Degeneration (AMD) is the leading cause of central vision loss among older adults worldwide. Patients with AMD often require frequent monitoring of visual function and disease progression, typically through multiple follow-up visits involving optical coherence tomography (OCT), visual acuity testing (VA), and clinical consultations.
While digital self-monitoring tools have emerged as promising solutions to reduce the burden of in-clinic visits, many elderly patients face challenges in engaging with these platforms due to visual impairment, limited digital literacy, and poorly optimised user interfaces. These barriers may reduce patient willingness to adopt such systems and undermine their long-term effectiveness.
To address this gap, the study team has developed the web-based AVIGA (Automated Vision Impairment Gaze-tracking Analysis) system, which is a portable, self-administered, home-based digital monitoring system designed to minimise cognitive load and maximise usability for elderly AMD patients. The platform integrates patient-centred design principles such as simplified navigation, optimised text, and multimodal feedback (visual and audio) to empower users to independently track their visual health.
A prospective, single-site usability trial to evaluate the AVIGA platform using validated human factors measures: the System Usability Scale (SUS), the Technology Acceptance Model (TAM) will be conducted. By examining the relationship between usability, cognitive load, and perceived empowerment, this study aims to identify critical user interface and user experience (UI/UX) design factors that influence willingness to adopt and sustain use of digital health tools among elderly AMD patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 55 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects in the age group ≥ 55 to 99 years old.
- •Both genders
- •Able to understand verbal spoken instructions in British/American English, Chinese or Bahasa Melayu and demonstrate device functionality and implementation.
- •Subjects undergoing treatment for Wet-AMD without any signs and symptoms of recurrence of active AMD (AMD recurrence: choroidal neovascularisation, intraretinal or subretinal fluid is present) with OCT lesion fluid volume more than 2mm2 or ILM height more than 300µm.
- •Ability to comply with the study protocol, in the investigator's judgment.
- •Subjects must be able to understand and provide informed consent. A signed informed consent form must be provided before any study assessments.
排除标准
- •Unable to understand verbal spoken instructions and demonstrate device functionality and implementation.
- •Unable to turn on and connect their computer to the AVIGA platform independently.
- •Any ocular surgery in the previous 3 months, or vitrectomy in the previous 12 months
- •Any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid in the study eye
- •Any concurrent intraocular condition in the study eye that, in the opinion of the investigator, could either reduce the potential for visual improvement or require medical or surgical intervention during the study
- •Any prior or concomitant treatment for CNV or vitreomacular-interface abnormalities in the study eye.
- •History of idiopathic or autoimmune-associated uveitis in either eye
- •Active ocular inflammation or suspected or active ocular or periocular infection in either eye.
- •Severe cognitive impairment, comorbid conditions severely limiting participation (e.g., advanced hearing loss)
结局指标
主要结局
Assess System Usability
时间窗: Baseline, Mid-point (6 months from baseline ±3 months), End-point (12 months from baseline ±3 months)
Measure and evaluate overall system usability across three checkpoints (Baseline, Mid-point, and End-point) using the System Usability Scale (SUS), a 10-item questionnaire rated on a 5-point Likert scale.
Assess System Acceptance
时间窗: Baseline, Mid-point (6 months from baseline ±3 months), End-point (12 months from baseline ±3 months)
Measure and evaluate overall acceptance towards system adoption across three checkpoints (Baseline, Mid-point, and End-point) using 8 items from the Technology Acceptance Model (TAM), rated on a 5-point Likert scale.
次要结局
- Track Change Over Time(Baseline, Mid-point (6 months from baseline ±3 months), End-point (12 months from baseline ±3 months))
研究者
Laude Augustinus
Senior Consultant
Tan Tock Seng Hospital