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NCT Number: NCT07545473

Retinal Hyperspectral Imaging in Neurodegenerative Diseases

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.

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Key information

About this study

The retina is the inner part of the eye that is developmentally linked to the brain. Taking specialised pictures of the retina of the eye can reveal information about a person's eye health as well as their general health. Several research studies have shown that there are subtle differences in the retinas of people with dementia or neurodegenerative diseases including Alzheimer's disease and Parkinson's disease, compared to those without the disease. For example, in Alzheimer's disease, a protein amyloid beta builds up in the brain and in the retina of the eye. The build up of amyloid beta corresponds with the stage of dementia. Currently, measuring amyloid beta requires an expensive test, known as a PET scan, that can be difficult to access and involves exposure to radiation, which means that it cannot be repeated often. The other way to measure amyloid beta levels involves a collection of fluid (cerebrospinal fluid) from around the spinal cord. The development of a cheap, quick and easy test to detect the level of amyloid deposits would be a major advance for not only people with Alzheimer's disease but other forms of dementia and neurodegenerative diseases. It may allow easier monitoring of the progression of the disease and, importantly, monitoring of the effectiveness of new treatments to slow progression of the disease. Different changes occur in the retina in other types of brain diseases, suggesting that eye scans may help to detect a range of different neurodegenerative diseases.

Over the past few years, our research group has been studying a new type of camera, known as a hyperspectral camera, that can take images of the retina using many different colours (wavelengths) of light. It provides us with very detailed information about the structure of the retina that we cannot get using standard cameras. The eye scan is safe, quick and easy. We have shown that the eye scan can provide valuable information about people's eye and brain health. We now aim to test whether the scans can be used to find changes in the retina that are linked with dementia or neurodegenerative diseases. If changes are found, this could be used in future to help detect dementia or neurodegenerative diseases in the early stages or to monitor disease progression.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Be willing to participate in the study and attend the Centre for Eye Research Australia.
  • Be accompanied by a friend or family member.

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Diagnostic classification of neurodegenerative diseases using hyperspectral retinal imaging

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

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Darvy Dang

CONTACT

[email protected]

+61 3 9959 0102

Sponsors and collaborators

Lead sponsor

Center for Eye Research Australia

Other

Registry information

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Apr 22, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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