Age-Related Macular DegenerationNCT07555574
Defining Retinal Structures Using Hyperspectral Retinal Imaging
A study testing Hyperspectral camera in people with Age-Related Macular Degeneration and Diabetic Retinopathy, run by Center for Eye Research Australia at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age-Related Macular Degeneration, Diabetic Retinopathy, Glaucoma
- What is being tested?
- Hyperspectral camera
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Jan 2025to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
The Centre for Eye Research Australia
Melbourne, Victoria, 3002
Darvy Dang, Masters of Orthoptics, +61 3 9959 0102, darvy.dang@unimelb.edu.au
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.
Read the detailed description
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.
- Conditions
- Age-Related Macular Degeneration, Diabetic Retinopathy, Glaucoma, Retinal Diseases, Healthy Volunteers
- Being tested
- Hyperspectral camera
- Medical subject headings
- Macular Degeneration, Diabetic Retinopathy, Glaucoma, Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperspectral cameraDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Hyperspectral camera |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During study visit (baseline data collection); analyses performed after completion of participant recruitment and imaging dataset acquisition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start1 Jan 2025
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Eye Research Australia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07555574
- Sponsor's protocol ID
- 167/21
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan for sharing individual participant data (IPD) has not yet been finalised. This is a multi-modal imaging study involving large hyperspectral and ophthalmic imaging datasets, and decisions regarding data sharing will depend on completion of primary analyses, data governance requirements, and ethical approvals. The feasibility of appropriate de-identification and secure sharing mechanisms is under review.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining Retinal Structures Using Hyperspectral Retinal Imaging
- ClinicalTrials.gov ID
- NCT07555574
- Acronym / sponsor ID
- 167/21
- Conditions
- Age-Related Macular Degeneration, Diabetic Retinopathy, Glaucoma, Retinal Diseases, Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Center for Eye Research AustraliaUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyperspectral retinal imaging | Experimental | Device: Hyperspectral cameraParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperspectral cameraHyperspectral 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. | Device | Hyperspectral retinal imaging |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: Undecided. The plan for sharing individual participant data (IPD) has not yet been finalised. This is a multi-modal imaging study involving large hyperspectral and ophthalmic imaging datasets, and decisions regarding data sharing will depend on completion of primary analyses, data governance requirements, and ethical approvals. The feasibility of appropriate de-identification and secure sharing mechanisms is under review.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperspectral camera in people with Age-Related Macular Degeneration and Diabetic Retinopathy, run by Center for Eye Research Australia at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Darvy Dang (+61 3 9959 0102, darvy.dang@unimelb.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.