Defining Retinal and Choroidal Structures Using Hyperspectral Imaging

NCT07530783 | Terminated DMC

• 1 other identifier: 16/1265H/21
• Study Type: interventional
• Target: 679
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Retinal Disease

Keywords

Hyperspectral imaging

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Hyperspectral retinal imaging cohort

EXPERIMENTAL

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

Interventions

Hyperspectral retinal imaging DEVICE

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.

Also known as: Optina Metabolic Hyperspectral Retinal Camera, CERA hyperspectral retinal camera

Hyperspectral retinal imaging cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Center for Eye Research Australia: lead

MeSH Terms

Conditions

Retinal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 15, 2026
• Study Start: February 25, 2016
• Primary Completion: January 21, 2025
• Study Completion: January 21, 2025
• Last Updated: April 15, 2026

Record last verified: 2026-04