Defining Retinal and Choroidal Structures Using Hyperspectral Imaging

This study investigates a novel, non-invasive imaging technique called hyperspectral retinal imaging to improve the identification and characterisation of retinal and choroidal structures in both healthy and diseased eyes. Hyperspectral imaging captures retinal images across multiple wavelengths of light, generating detailed spectral information that may reveal biological and structural features not visible with conventional retinal photography.

Approximately 1000 participants will undergo retinal imaging at specialist eye clinics in Melbourne, Australia. The study aims to determine whether hyperspectral imaging can detect spectral signatures associated with retinal and optic nerve diseases such as diabetic retinopathy, glaucoma, and age-related macular degeneration, and whether these signatures correlate with disease severity.

Study Overview

• Status: Terminated
• Conditions: Retinal Disease
• Intervention / Treatment: Device: Hyperspectral retinal imaging

Detailed Description

This investigator-initiated imaging study aims to evaluate the utility of hyperspectral retinal imaging (HSI) for the identification and characterisation of retinal and choroidal structures in both normal and diseased eyes.

Hyperspectral imaging is a non-invasive retinal imaging modality that captures sequential images across multiple wavelengths of light (typically >25 spectral bands and up to approximately 90 wavelengths). This produces a three-dimensional dataset ("hypercube") containing spatial and spectral information for each pixel, enabling analysis of tissue-specific spectral reflectance properties. The technique differs from conventional retinal photography, which typically uses three colour channels (red, green, and blue), by providing significantly enhanced spectral resolution.

The study population will include approximately 1000 participants recruited from multiple ophthalmic clinics in Melbourne, Australia. Participants will be recruited across a range of normal ocular health and retinal disease states, including but not limited to diabetic retinopathy, glaucoma, and age-related macular degeneration.

Imaging will be performed at the Centre for Eye Research Australia (CERA) using two hyperspectral imaging systems: the Optina Diagnostics Metabolic Hyperspectral Retinal Camera and a prototype hyperspectral camera developed at CERA. Both systems acquire rapid sequential retinal images across visible to near-infrared wavelengths. The Optina device provides a field of view of approximately 26 degrees and uses a tunable supercontinuum light source, while the CERA prototype uses LED-based illumination with optical filtering and provides a field of view of approximately 35 degrees.

Participants may undergo pharmacological pupil dilation prior to imaging to improve image quality. Each study visit will last approximately 60 minutes, including dilation and imaging procedures.

Image data will undergo registration and processing to correct for eye movement and system response, enabling extraction of pixel-level spectral signatures. Computational analysis methods will be developed to identify and quantify retinal and choroidal features and to explore associations between spectral signatures and structural or functional measures of disease.

The primary objectives are to optimise hyperspectral imaging acquisition protocols for retinal and optic nerve structures, to determine whether spectral signatures associated with retinal pathology can be detected using hyperspectral imaging, and to assess whether these spectral changes correlate with clinical measures of disease severity.

• Study Type: Interventional
• Enrollment (Actual): 679
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Adults aged 18 years and older
• Able to provide informed consent
• Willing and able to attend study imaging sessions
• Participants with healthy eyes or diagnosed retinal/optic nerve disease (including but not limited to diabetic retinopathy, glaucoma, and age-related macular degeneration)
• Adequate media clarity to permit retinal imaging as determined by investigator

Exclusion Criteria:

• Inability to provide informed consent
• Known history of narrow anterior chamber angles or risk of acute angle closure where pupil dilation is contraindicated
• Ocular media opacities preventing adequate retinal imaging (e.g., dense cataract, severe corneal opacity, vitreous hemorrhage)
• Any condition that, in the opinion of the investigator, would make participation unsafe or compromise study data quality
• Allergy or contraindication to pharmacologic mydriatic agents used for pupil dilation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• 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 retinal imaging cohort; Participants undergo non-invasive hyperspectral retinal imaging of the fundus using two imaging systems: the Optina Diagnostics Metabolic Hyperspectral Retinal Camera and a prototype hyperspectral camera developed at the Centre for Eye Research Australia. Imaging is performed following pharmacological pupil dilation (mydriasis) as per standard ophthalmic procedure. The intervention involves multi-wavelength retinal image acquisition across visible to near-infrared spectra, similar in experience to conventional fundus photography but with sequential hyperspectral capture. Participants attend a single study visit of approximately 60 minutes, with optional repeat imaging visits on a voluntary basis for longitudinal data collection. No investigational drugs or therapeutic procedures are administered as part of the imaging intervention. Data collected includes hyperspectral retinal and choroidal image datasets for subsequent computational and spectroscopic analysis

Device: Hyperspectral retinal imaging; Participants undergo non-invasive hyperspectral retinal imaging of the fundus using hyperspectral imaging devices that acquire sequential retinal images across multiple wavelengths (visible to near-infrared spectrum). Two devices may be used: the Optina Diagnostics Metabolic Hyperspectral Retinal Camera and a prototype hyperspectral camera developed at the Centre for Eye Research Australia. Imaging is performed following pharmacological pupil dilation (mydriasis) where required, and is similar in procedure to standard fundus photography, with the difference that multiple spectral channels (typically >25 and up to ~90 wavelengths) are captured in rapid sequence to generate a hyperspectral image dataset ("hypercube"). The intervention is non-invasive, does not involve radiation or therapeutic treatment, and is used solely for retinal and choroidal imaging data acquisition for research analysis of structural and spectroscopic retinal features.; Other Names: Optina Metabolic Hyperspectral Retinal Camera; CERA hyperspectral retinal camera

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Optimisation and characterisation of hyperspectral retinal imaging spectral signatures in normal and diseased eyes	To determine whether hyperspectral retinal imaging can reliably detect and characterise spectroscopic signatures associated with retinal and optic nerve structures in healthy participants and in participants with retinal diseases. This includes assessment of whether distinct spectral features can be identified and differentiated between normal retinal tissue and pathological retinal or optic nerve tissue, and evaluation of image quality and spectral signal consistency across imaging conditions and devices.	Single study visit (approximately 60 minutes), with additional optional follow-up imaging visits for longitudinal data collection where applicable.

Collaborators and Investigators

• Sponsor: Center for Eye Research Australia

Study record dates

Study Major Dates

• Study Start: February 25, 2016
• Primary Completion (Actual): January 21, 2025
• Study Completion (Actual): January 21, 2025

Study Registration Dates

• First Submitted: April 8, 2026
• First Submitted That Met QC Criteria: April 8, 2026
• First Posted (Actual): April 15, 2026

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Hyperspectral imaging
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases
• Other Study ID Numbers: 16/1265H/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. Given the exploratory and image-based nature of this study, which involves large hyperspectral retinal imaging datasets and ongoing development of analysis methods, decisions regarding data sharing will depend on the completion of primary analyses, ethical approvals, and institutional data governance requirements. The feasibility of de-identification and appropriate data access frameworks is currently 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