Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07555574

Defining Retinal Structures Using Hyperspectral Retinal Imaging

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Centre for Eye Research Australia

Melbourne, Victoria, 3002, Australia

Location status: Recruiting

Location contact

Darvy Dang, Masters of Orthoptics

CONTACT

[email protected]

+61 3 9959 0102

About this study

This is a investigator-initiated imaging study assessing hyperspectral retinal imaging (HSI) for characterising retinal and optic nerve structures in healthy and diseased eyes.

HSI acquires retinal images across multiple wavelengths (>25 bands), producing a spectral "hypercube" containing spatial and spectral information for each pixel. This provides more detailed tissue information than conventional colour fundus photography.

Approximately 1000 participants will be recruited from ophthalmology clinics in Melbourne. All participants will undergo standard ophthalmic assessment and hyperspectral retinal imaging using the Optina device and a CERA prototype camera.

Hyperspectral images will be processed with registration and spectral normalisation to extract pixel-level reflectance signatures. These data will be analysed using statistical and machine learning methods and compared with established imaging biomarkers to evaluate their ability to distinguish disease states.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Darvy Dang

CONTACT

[email protected]

+61 3 9959 0102

Sponsors and collaborators

Lead sponsor

Center for Eye Research Australia

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 29, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.