AVIGA3: Using an 'Automated Vision Assessment and Impairment Detection Through Gaze Analysis' Through a Longitudinal, Open-labelled, Randomized Clinical Trial to Monitor Recurrence of Aged-related Macular Degeneration in a Home-based Setting (Cohort 2.0).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Diagnostic Accuracy Using One-Sided Confidence Interval or One-Sided Hypothesis Test
研究概览
简要总结
Age-Macular Degeneration (AMD) is a common eye condition and a leading cause of vision loss among people age 50 and older. It causes damage to the macula, a small area near the centre of the retina needed for sharp, central vision. It is estimated that the prevalence of early and late AMD in Asian populations aged 40 to 79 were 6.8% and 0.56% respectively. Prevalence in white populations estimated from large population studies were 8.8% and 0.59% respectively. With the aging population and people living longer, these numbers will only increase. Hence, this study aims to develop a system to evaluate the AVIGA system through remote monitoring for disease recurrence of wet aged-related macular degeneration using eye gaze tracking.
详细描述
Age-Related Macular Degeneration (AMD) is one of the main causes of central vision loss. Most patients require pharmacologic treatment with anti-vascular endothelial growth factor (VEGF) agents with multiple follow-up visits that include optical coherence tomography (OCT), visual acuity testing and multiple injections.
The high frequency of visits puts pressure on eye clinics and can be extremely stressful for both patients and their caregivers. Therefore, portable and rapidly deployable self-administered home-based examination devices are key to making telemedicine a reality.
The study team has developed a portable, self-administered online based assessment, designed for gaze-tracking and monitoring of patients with retinal diseases such as AMD, and choroidal neovascularization (CNV) that require multiple anti-VEGF injections.
The team have confirmed the performance of the AVIGA system and validated the retinal thickness measurements obtained with this device by comparing it to in-hospital Optical Coherence Tomography (OCT) (Heidelberg Spectralis). In this study, the team will conduct an open-labelled, randomized clinical trial (RCT) to compare the efficacy and cost-effectiveness of a Pro Re Nana (PRN) management regimen enhanced with the AVIGA home-monitoring platform for the detection of central metamorphopsia with existing PRN standard of care for patients with AMD exiting the anti-VEGF injection regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 50 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 ≥ 50 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.
- •Able to turn on and connect the web-camera to a computer independently or with the help of family.
- •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 2 mm3 or ILM height more than 250µm.
- •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 the web-camera to a computer 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.
研究组 & 干预措施
Amsler Grid
The Amsler grid is a tool used to monitor the macula, the central part of the retina, for changes in vision that can be indicative of various eye conditions, particularly age-related macular degeneration (AMD). It helps detect and monitor metamorphopsia (distorted vision) or scotoma (blind spots) in the central visual field.
干预措施: Amsler Grid (Diagnostic Test)
AVIGA Arm
The AVIGA system tracks eye movements following generated patterns projected on the screen. Assessment of affected and unaffected eyes can be achieved at home using any computer screen.
AVIGA is a home-based gaze-tracking system for monitoring of high-risk eyes with wet-AMD.
干预措施: AVIGA (Device)
结局指标
主要结局
Diagnostic Accuracy Using One-Sided Confidence Interval or One-Sided Hypothesis Test
时间窗: 12 Months
To assess whether the AVIGA device is non-inferior to the standard of care (Amsler grid) in detecting recurrence of wet-AMD during patient recall, by comparing both generated scores, validated by OCT readings.
次要结局
- Correlation with Optical Coherence Tomography (OCT)(12 Months)
- User Experience & Functionality(12 Months)
研究者
Laude Augustinus
Senior Consultant
Tan Tock Seng Hospital