Recruiting

Defining Retinal Structures Using Hyperspectral Retinal Imaging

ClinicalTrials.gov IDNCT07555574

PhaseNA

Enrollment1000

SponsorCenter for Eye Research Australia

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

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

About this study

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.

Interventions

Device: Hyperspectral camera — 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

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

Eligibility information

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

Study locations

The Centre for Eye Research Australia, Melbourne, Victoria 3002 Australia

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.