Detecting Beta-amyloid in the Retina

Non-invasive Retinal Imaging to Detect Beta-amyloid in Alzheimer's Disease

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.

Study Overview

• Status: Terminated
• Conditions: Dementia; Alzheimer Disease
• Intervention / Treatment: Device: Hyperspectral camera

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.

• Study Type: Interventional
• Enrollment (Actual): 186
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3002
      • The Centre for Eye Research Australia

Participation Criteria

Eligibility Criteria

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

Description

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

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

Other: Detecting Beta-amyloid in the Retina

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 performance of hyperspectral retinal imaging for detection of Alzheimer's disease-related beta-amyloid	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.	Single study visit (baseline imaging session; approximately 60 minutes)

Collaborators and Investigators

• Sponsor: Center for Eye Research Australia

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2016
• Primary Completion (Actual): January 9, 2024
• Study Completion (Actual): January 9, 2024

Study Registration Dates

• First Submitted: April 8, 2026
• First Submitted That Met QC Criteria: April 8, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Hyperspectral imaging
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease; Dementia
• Other Study ID Numbers: 15/1253H/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