Retinal Hyperspectral Imaging in Neurodegenerative Diseases

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30+
SponsorCenter for Eye Research Australia

About this trial

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 a wealth of information about the retinal structure. Our group has developed evidence supporting a role for this technology in the detection of retinal amyloid beta in Alzheimer's disease. We are undertaking further studies to establish the role of this method in the assessment of people with dementia, or those at risk of Alzheimer's disease. In addition, we wish to test whether the approach may have value in other forms of dementia or neurodegenerative disease such as Parkinson's disease, Lewy-Body dementia or vascular dementia.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Aged over 30 years.

Have dementia or a neurodegenerative disease such as Alzheimer's disease, Parkinson's disease, Lewy body dementia, Niemann-Pick type 2 or vascular dementia (age-matched and sex-matched controls will also be recruited).

With the exception of participants with Parkinson's disease and Lewy body disease, for whom clinical examination by a neurologist is sufficient to establish a clinical diagnosis of probable dementia with Lewy Body or probable Parkinson disease dementia, all participants must have previously undergone at least of one of the following tests to help to confirm a clinical diagnosis of dementia or neurodegenerative disease: genetic tests, blood biomarker tests (amyloid, tau, neurofilament light), a brain amyloid beta PET scan, or cerebrospinal fluid tests.

Have a minimum best corrected visual acuity level of 6/60 in both eyes and no major eye problems, such as advanced age-related macular degeneration, advanced glaucoma, or greater than moderate non-proliferative diabetic retinopathy.

Disqualifiers

Inability to provide informed consent

Ocular conditions preventing adequate retinal imaging (e.g., dense cataract, severe corneal opacity, vitreous haemorrhage)

Known contraindication to pharmacological pupil dilation

Any condition that, in the investigator's opinion, would compromise participant safety or image quality

Trial design

Design model

Single group

Treatments tested in this trial

  • Hyperspectral camera

    Device

    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.

Treatment groups

930 Participants
are divided into 1 treatment group
Group A: Hyperspectral cameraExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Diagnostic classification of neurodegenerative diseases using hyperspectral retinal imaging

Evaluation of whether hyperspectral retinal imaging-derived biomarkers can distinguish between diagnostic groups including Alzheimer's disease, Lewy body dementia, Parkinson's disease, frontotemporal dementia, vascular dementia, and cognitively healthy controls. Diagnostic performance will be assessed using AI-based classification outputs, including sensitivity, specificity, classification accuracy, and area under the receiver operating characteristic curve (AUC).

Time frame
During study visit (baseline data collection); analyses performed after completion of participant recruitment and imaging dataset acquisition

Secondary outcomes

Other outcomes

Sponsors and contacts

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