The Centre for Eye Research Australia
Melbourne, Victoria, 3002, Australia
Location status: Recruiting
NCT Number: NCT07555574
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Melbourne, Victoria, 3002, Australia
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Contact information is provided by the study sponsor or research team.
Center for Eye Research Australia
Other
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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.
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