Non-invasive Retinal Imaging to Detect Beta-amyloid in Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- Diagnostic performance of hyperspectral retinal imaging for detection of Alzheimer's disease-related beta-amyloid
研究概览
简要总结
Hyperspectral retinal imaging is a non-invasive imaging modality in which a series of images of the retina are captured using light of different wavelengths. The resulting "hypercube" of data provides detailed information about retinal structure. Previous research has demonstrated a potential role for this technology in the detection of retinal amyloid beta in Alzheimer's disease. This study aims to further evaluate the use of hyperspectral retinal imaging in the assessment of individuals with dementia or those at risk of Alzheimer's disease.
详细描述
The study involves retinal imaging using specialised cameras to capture detailed photographs of the eye. Imaging includes the use of two hyperspectral retinal cameras, which are similar to standard retinal cameras but use multi-wavelength (multicoloured) light instead of a conventional white-light flash.
These hyperspectral imaging devices are investigational and are not approved for routine clinical use in Australia. Their use in this research has been approved by the Human Research Ethics Committee of the Royal Victorian Eye and Ear Hospital following scientific and ethical review. The Therapeutic Goods Administration of Australia has been notified of their use under the Clinical Trial Notification (CTN) scheme.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 30 years and older
- •Diagnosis of Alzheimer's disease or no evidence of Alzheimer's disease (including control participants or those with other neurodegenerative conditions such as Parkinson's disease, Lewy body dementia, or vascular dementia)
- •Prior confirmation of Alzheimer's disease diagnosis by genetic testing or positron emission tomography (PET) scan (where applicable)
- •Able to undergo cognitive assessment if required (for control participants without recent testing within the past 6 months)
- •No major ocular conditions that would preclude retinal imaging
- •Willing and able to attend the Royal Victorian Eye and Ear Hospital
- •Able to attend with a friend or family member
排除标准
- •Presence of significant ocular disease that prevents adequate retinal imaging
- •Inability to undergo study procedures or comply with study requirements
- •Any condition that, in the opinion of the investigators, would make participation unsafe or compromise data quality
研究组 & 干预措施
Detecting Beta-amyloid in the Retina
干预措施: Hyperspectral camera (Device)
结局指标
主要结局
Diagnostic performance of hyperspectral retinal imaging for detection of Alzheimer's disease-related beta-amyloid
时间窗: Single study visit (baseline imaging session; approximately 60 minutes)
Assessment of whether hyperspectral retinal imaging can distinguish participants with Alzheimer's disease from cognitively healthy controls based on retinal spectral reflectance signatures (particularly in the 480-520 nm wavelength range). Performance will be evaluated using quantitative image-derived biomarkers and classification accuracy (e.g., sensitivity, specificity, and area under the receiver operating characteristic curve) generated from computer-assisted image analysis.
次要结局
未报告次要终点