Defining Retinal Structures Using Hyperspectral Retinal Imaging

Sponsor
Center for Eye Research Australia
Study ID
NCT07555574
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

First listed
Apr 29, 2026
Start date
Jan 1, 2025
Status verified
Apr 2026
Primary completion
Dec 30, 2028
Completion
Dec 30, 2028

Study Design

Enrollment
1,000 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Hyperspectral retinal imaging
    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.

Primary Outcome Measure

Diagnostic performance of hyperspectral imaging-derived spectral score for detection of retinal disease [ Time Frame: During study visit (baseline data collection); analyses performed after completion of participant recruitment and imaging dataset acquisition ]

Central Contacts

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