Defining Retinal Structures Using Hyperspectral Retinal Imaging

NCT07555574 | Recruiting

• 1 other identifier: 167/21
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates hyperspectral retinal imaging as a novel, non-invasive imaging technique to characterise retinal and optic nerve structures in healthy individuals and patients with eye disease. Hyperspectral imaging captures retinal data across multiple wavelengths to generate detailed spectral information that may reveal features not visible with conventional retinal photography. Approximately 1000 participants will undergo multi-modal ophthalmic imaging in Melbourne, Australia, including hyperspectral imaging, OCT, fundus photography, and related tests. The study aims to compare hyperspectral imaging with standard imaging methods and assess its ability to identify retinal biomarkers associated with diseases such as diabetic retinopathy, glaucoma, and age-related macular degeneration.

Conditions

Age-Related Macular Degeneration; Diabetic Retinopathy; Glaucoma; Retinal Diseases; Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Diagnostic performance of hyperspectral imaging-derived spectral score for detection of retinal disease

  To assess the ability of hyperspectral retinal imaging to distinguish between healthy and diseased eyes using a quantitative hyperspectral spectral score derived from image analysis algorithms (e.g., DROP-D or machine learning models). Diagnostic performance will be evaluated against clinical diagnosis using receiver operating characteristic (ROC) analysis.

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

Study Arms (1)

Hyperspectral retinal imaging

EXPERIMENTAL

Participants undergo non-invasive hyperspectral retinal imaging as part of a multi-modal ophthalmic imaging protocol. Hyperspectral imaging is performed using the Optina Diagnostics Metabolic Hyperspectral Retinal Camera and/or a prototype hyperspectral camera developed at the Centre for Eye Research Australia. The intervention involves sequential retinal imaging across multiple wavelengths (\>25 spectral bands) following standard dilated fundus examination. Imaging is similar to conventional retinal photography but provides additional spectral information for each retinal pixel. Participants also undergo standard clinical imaging (including OCT, OCT angiography, fundus photography, and autofluorescence) for comparison. The study is observational and non-therapeutic, with hyperspectral imaging used solely for research analysis of retinal structure and spectral biomarkers.

Device: Hyperspectral camera

Interventions

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.

Hyperspectral retinal imaging

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 a study visit at the Centre for Eye Research Australia
• Participants with diagnosed retinal or optic nerve disease (e.g., diabetic retinopathy, glaucoma, age-related macular degeneration)
• Age- and sex-matched healthy control participants without known retinal or optic nerve disease

You may not qualify if:

• 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
• History of narrow anterior chamber angle or risk of angle closure glaucoma where dilation is considered unsafe
• Any condition that, in the investigator's opinion, would compromise participant safety or image quality

Sponsors & Collaborators

• Center for Eye Research Australia: lead

Study Sites (1)

The Centre for Eye Research Australia

Melbourne, Victoria, 3002, Australia

RECRUITING

MeSH Terms

Conditions

Macular Degeneration; Diabetic Retinopathy; Glaucoma; Retinal Diseases

Condition Hierarchy (Ancestors)

Retinal Degeneration; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Ocular Hypertension

Central Study Contacts

Darvy Dang

CONTACT

+61 3 9959 0102; darvy.dang@unimelb.edu.au

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 29, 2026
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

AU (1)