Alzheimer Disease, Dementia
Conditions
Keywords
Hyperspectral imaging
Brief summary
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.
Detailed description
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.
Interventions
DEVICEHyperspectral camera
Hyperspectral imaging is performed with the Metabolic Hyperspectral Retinal Camera (Optina Diagnostic, Montreal, Canada) and a prototype camera developed by researchers at the Centre for Eye Research Australia (CERA). The Metabolic Hyperspectral Retinal Camera is similar to a typical fundus imager but it incorporates a tunable light source which is able to transmit safe light levels within a wavelength range covering the visible to near infrared with a narrow bandwidth (\< 3nm). This instrument is capable of imaging a 26° field-of-view of retina at 90 wavelengths in less than a second, thus minimizing discomfort and limiting the influence of eye movements. The hyperspectral camera developed by CERA researchers is a non-mydriatic fundus camera that uses light emitting diodes (LEDs) and an optical variable bandpass filter to tune the illumination wavelengths.
Sponsors
Center for Eye Research Australia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic performance of hyperspectral retinal imaging for detection of Alzheimer's disease-related beta-amyloid | 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. |
Countries
Australia
Outcome results
None listed