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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease; Neurodegenerative Diseases; Dementia; Alzheimer Disease; Lewy Body Disease; Frontotemporal Dementia; Vascular Dementia; Niemann-Pick Diseases
• Intervention / Treatment: Device: Hyperspectral camera

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 930
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Darvy Dang; Phone Number: +61 3 9959 0102; Email: darvy.dang@unimelb.edu.au

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3002
      • Recruiting
      • The Centre for Eye Research Australia
      • Contact: Darvy Dang; Phone Number: +61 3 9959 0102; Email: darvy.dang@unimelb.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Aged over 30 years.
2. 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).
3. 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.
4. 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.
5. Be willing to participate in the study and attend the Centre for Eye Research Australia.
6. Be accompanied by a friend or family member.

Exclusion Criteria:

1. Inability to provide informed consent
2. Ocular conditions preventing adequate retinal imaging (e.g., dense cataract, severe corneal opacity, vitreous haemorrhage)
3. Known contraindication to pharmacological pupil dilation
4. Any condition that, in the investigator's opinion, would compromise participant safety or image quality

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Hyperspectral 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.

Device: Hyperspectral 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	During study visit (baseline data collection); analyses performed after completion of participant recruitment and imaging dataset acquisition

Collaborators and Investigators

• Sponsor: Center for Eye Research Australia

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2021
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: April 8, 2026
• First Submitted That Met QC Criteria: April 21, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Retina; Hyperspectral imaging
• Additional Relevant MeSH Terms: Synucleinopathies; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Metabolic Diseases; Neurocognitive Disorders; Tauopathies; Lymphatic Diseases; Movement Disorders; Lipid Metabolism Disorders; Lysosomal Storage Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Arteriosclerosis; Arterial Occlusive Diseases; Leukoencephalopathies; Lipid Metabolism, Inborn Errors; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Lysosomal Storage Diseases, Nervous System; Histiocytosis, Non-Langerhans-Cell; Histiocytosis; Frontotemporal Lobar Degeneration; Sphingolipidoses; Lipidoses; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nutritional and Metabolic Diseases; Hemic and Lymphatic Diseases; Alzheimer Disease; Parkinson Disease; Dementia; Neurodegenerative Diseases; Frontotemporal Dementia; Dementia, Vascular; Lewy Body Disease; Niemann-Pick Diseases
• Other Study ID Numbers: 166/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The plan for sharing individual participant data (IPD) has not yet been finalised. This is a multi-modal imaging study involving large hyperspectral and ophthalmic imaging datasets, and decisions regarding data sharing will depend on completion of primary analyses, data governance requirements, and ethical approvals. The feasibility of appropriate de-identification and secure sharing mechanisms is under review.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No