Personalized Shared Eye-care Identification of Age-related Macular Degeneration Using Artificial Intelligence and Telemedicine in a Prospective, Exploratory, Multinational, Multicentre Cross-sectional Study Matching Optometrist Office-based Sites With Clinical Supervision
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 5,000
- 主要终点
- Identification of different AMD stages on OCT images from a community-based setting to calculate the real-world prevalence of AMD
研究概览
简要总结
Office-based optometrist centres equipped with low-cost OCT devices can be used for screening of age-related macular degeneration. Matching next-door optometrist centres with clinical sites introduces a shared care service in an unprecedented and broad manner and offers timely and inclusive access to eye care for all citizens affected by the most frequent blinding disease in western countries.
The aim of the study is to detect AMD in a next-door office-based setting on an individual level using low-cost OCT, through a telemedicine feedback loop.
The specific aims of this study are:
- Setting up a network of optometrist centres matched to clinical sites to perform shared care to protect eyesight in the elderly population.
- Identify imaging biomarkers of age-related macular degeneration from OCT imaging.
- Give a risk estimation of progression using a one-time low-cost OCT scan
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
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
- 是
入选标准
- •Age: 55-99 years old
- •Preserved visual function, defined as visual acuity better than or equal to 0.3logMAR in one or both eyes
排除标准
- •Refractive errors with mean spherical equivalent (MSE) greater than +/-6.00, with no limit to astigmatic component.
结局指标
主要结局
Identification of different AMD stages on OCT images from a community-based setting to calculate the real-world prevalence of AMD
时间窗: 2 years
AMD staging will be carried out by a certified ophthalmologist at the Medical University of Vienna according to the following parameters: 1. Healthy aging retina, including drupelets \< 63 µm \[3\] 2. Early AMD as defined in the protocol \[3\] (see 7.3 disease definitions): Medium drusen \>63 µm and \>125 µm. No AMD pigmentary abnormalities. 3. Intermediate AMD as defined in the protocol \[3\] (see 7.3 disease definitions): Large druse \> 125 µm and/or and pigmentary abnormalities 4. Late AMD: Geographic Atrophy as defined in the protocol \[3,6\] (see 7.3 disease definitions) 5. Other diseases: including neovascular AMD, RVO, DME, CCS, Stargardt disease, Pattern dystrophy, etc.
次要结局
- As a post-hoc analysis, the diagnostic accuracy of AI algorithms to recognize changes associated with age-related macular degeneration in OCT volumes, will be evaluated in this real-world cohort.(2 years)
- Further biomarkers of AMD that are expected to be present in the cohort will be analyzed in order to assess whether they can be identified and quantified in this real-world cohort.(2 years)
研究者
Ursula Schmidt-Erfurth, M.D.
Prof.
Medical University of Vienna