Retinal DiseaseNCT07530783
Defining Retinal and Choroidal Structures Using Hyperspectral Imaging
A study testing Hyperspectral retinal imaging in people with Retinal Disease, run by Center for Eye Research Australia.
Trial summary
This study investigates a novel, non-invasive imaging technique called hyperspectral retinal imaging to improve the identification and characterisation of retinal and choroidal structures in both healthy and diseased eyes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Retinal Disease
- What is being tested?
- Hyperspectral retinal imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 679 participants
- Where
- No sites listed yet
- Study dates
- 25 Feb 2016to 21 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 study imaging sessions
- Participants with healthy eyes or diagnosed retinal/optic nerve disease (including but not limited to diabetic retinopathy, glaucoma, and age-related macular degeneration)
- Adequate media clarity to permit retinal imaging as determined by investigator
Who cannot join
- Inability to provide informed consent
- Known history of narrow anterior chamber angles or risk of acute angle closure where pupil dilation is contraindicated
- Ocular media opacities preventing adequate retinal imaging (e.g., dense cataract, severe corneal opacity, vitreous hemorrhage)
- Any condition that, in the opinion of the investigator, would make participation unsafe or compromise study data quality
- Allergy or contraindication to pharmacologic mydriatic agents used for pupil dilation
About this study
This study investigates a novel, non-invasive imaging technique called hyperspectral retinal imaging to improve the identification and characterisation of retinal and choroidal structures in both healthy and diseased eyes. Hyperspectral imaging captures retinal images across multiple wavelengths of light, generating detailed spectral information that may reveal biological and structural features not visible with conventional retinal photography.
Approximately 1000 participants will undergo retinal imaging at specialist eye clinics in Melbourne, Australia. The study aims to determine whether hyperspectral imaging can detect spectral signatures associated with retinal and optic nerve diseases such as diabetic retinopathy, glaucoma, and age-related macular degeneration, and whether these signatures correlate with disease severity.
Read the detailed description
This investigator-initiated imaging study aims to evaluate the utility of hyperspectral retinal imaging (HSI) for the identification and characterisation of retinal and choroidal structures in both normal and diseased eyes.
Hyperspectral imaging is a non-invasive retinal imaging modality that captures sequential images across multiple wavelengths of light (typically >25 spectral bands and up to approximately 90 wavelengths). This produces a three-dimensional dataset ("hypercube") containing spatial and spectral information for each pixel, enabling analysis of tissue-specific spectral reflectance properties. The technique differs from conventional retinal photography, which typically uses three colour channels (red, green, and blue), by providing significantly enhanced spectral resolution.
The study population will include approximately 1000 participants recruited from multiple ophthalmic clinics in Melbourne, Australia. Participants will be recruited across a range of normal ocular health and retinal disease states, including but not limited to diabetic retinopathy, glaucoma, and age-related macular degeneration.
Imaging will be performed at the Centre for Eye Research Australia (CERA) using two hyperspectral imaging systems: the Optina Diagnostics Metabolic Hyperspectral Retinal Camera and a prototype hyperspectral camera developed at CERA. Both systems acquire rapid sequential retinal images across visible to near-infrared wavelengths. The Optina device provides a field of view of approximately 26 degrees and uses a tunable supercontinuum light source, while the CERA prototype uses LED-based illumination with optical filtering and provides a field of view of approximately 35 degrees.
Participants may undergo pharmacological pupil dilation prior to imaging to improve image quality. Each study visit will last approximately 60 minutes, including dilation and imaging procedures.
Image data will undergo registration and processing to correct for eye movement and system response, enabling extraction of pixel-level spectral signatures. Computational analysis methods will be developed to identify and quantify retinal and choroidal features and to explore associations between spectral signatures and structural or functional measures of disease.
The primary objectives are to optimise hyperspectral imaging acquisition protocols for retinal and optic nerve structures, to determine whether spectral signatures associated with retinal pathology can be detected using hyperspectral imaging, and to assess whether these spectral changes correlate with clinical measures of disease severity.
- Conditions
- Retinal Disease
- Being tested
- Hyperspectral retinal imaging
- Keywords
- Hyperspectral imaging
- Medical subject headings
- Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperspectral retinal imagingDevice
Also called Optina Metabolic Hyperspectral Retinal Camera, CERA hyperspectral retinal camera
Participants undergo non-invasive hyperspectral retinal imaging of the fundus using hyperspectral imaging devices that acquire sequential retinal images across multiple wavelengths (visible to near-infrared spectrum). Two devices may be used: the Optina Diagnostics Metabolic Hyperspectral Retinal Camera and a prototype hyperspectral camera developed at the Centre for Eye Research Australia.
Imaging is performed following pharmacological pupil dilation (mydriasis) where required, and is similar in procedure to standard fundus photography, with the difference that multiple spectral channels (typically >25 and up to ~90 wavelengths) are captured in rapid sequence to generate a hyperspectral image dataset ("hypercube").
The intervention is non-invasive, does not involve radiation or therapeutic treatment, and is used solely for retinal and choroidal imaging data acquisition for research analysis of structural and spectroscopic retinal features.
| Study group | Role | What they receive |
|---|---|---|
| Hyperspectral retinal imaging cohort | Experimental | Participants undergo non-invasive hyperspectral retinal imaging of the fundus using two imaging systems: the Optina Diagnostics Metabolic Hyperspectral Retinal Camera and a prototype hyperspectral camera developed at the Centre for Eye Research Australia. Imaging is performed following pharmacological pupil dilation (mydriasis) as per standard ophthalmic procedure. The intervention involves multi-wavelength retinal image acquisition across visible to near-infrared spectra, similar in experience to conventional fundus photography but with sequential hyperspectral capture.
Participants attend a single study visit of approximately 60 minutes, with optional repeat imaging visits on a voluntary basis for longitudinal data collection. No investigational drugs or therapeutic procedures are administered as part of the imaging intervention. Data collected includes hyperspectral retinal and choroidal image datasets for subsequent computational and spectroscopic analysis Receives: Device: Hyperspectral retinal imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimisation and characterisation of hyperspectral retinal imaging spectral signatures in normal and diseased eyes
To determine whether hyperspectral retinal imaging can reliably detect and characterise spectroscopic signatures associated with retinal and optic nerve structures in healthy participants and in participants with retinal diseases. This includes assessment of whether distinct spectral features can be identified and differentiated between normal retinal tissue and pathological retinal or optic nerve tissue, and evaluation of image quality and spectral signal consistency across imaging conditions and devices.
Measured: Single study visit (approximately 60 minutes), with additional optional follow-up imaging visits for longitudinal data collection where applicable.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start25 Feb 2016
- Primary completion21 Jan 2025
- Study completion21 Jan 2025
Why it stopped: This study has been transferred to the Human Research Ethics Committee of St Vincent's Hospital Melbourne.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DiseaseStudies 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
- 679 participants (actual)
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
- NCT07530783
- Sponsor's protocol ID
- 16/1265H/21
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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. Given the exploratory and image-based nature of this study, which involves large hyperspectral retinal imaging datasets and ongoing development of analysis methods, decisions regarding data sharing will depend on the completion of primary analyses, ethical approvals, and institutional data governance requirements. The feasibility of de-identification and appropriate data access frameworks is currently under review.
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining Retinal and Choroidal Structures Using Hyperspectral Imaging
- ClinicalTrials.gov ID
- NCT07530783
- Acronym / sponsor ID
- 16/1265H/21
- Conditions
- Retinal Disease
- Keywords
- Hyperspectral imaging
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study has been transferred to the Human Research Ethics Committee of St Vincent's Hospital Melbourne.
- Enrolment
- 679 participants (actual)
- Lead sponsor
- Center for Eye Research AustraliaUniversity, hospital or other
- Study start
- 25 Feb 2016
- Primary completion
- 21 Jan 2025 (actual)
- Study completion
- 21 Jan 2025 (actual)
- First posted
- 15 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 investigates a novel, non-invasive imaging technique called hyperspectral retinal imaging to improve the identification and characterisation of retinal and choroidal structures in both healthy and diseased eyes. Hyperspectral imaging captures retinal images across multiple wavelengths of light, generating detailed spectral information that may reveal biological and structural features not visible with conventional retinal photography.
Approximately 1000 participants will undergo retinal imaging at specialist eye clinics in Melbourne, Australia. The study aims to determine whether hyperspectral imaging can detect spectral signatures associated with retinal and optic nerve diseases such as diabetic retinopathy, glaucoma, and age-related macular degeneration, and whether these signatures correlate with disease severity.
Detailed description
This investigator-initiated imaging study aims to evaluate the utility of hyperspectral retinal imaging (HSI) for the identification and characterisation of retinal and choroidal structures in both normal and diseased eyes.
Hyperspectral imaging is a non-invasive retinal imaging modality that captures sequential images across multiple wavelengths of light (typically >25 spectral bands and up to approximately 90 wavelengths). This produces a three-dimensional dataset ("hypercube") containing spatial and spectral information for each pixel, enabling analysis of tissue-specific spectral reflectance properties. The technique differs from conventional retinal photography, which typically uses three colour channels (red, green, and blue), by providing significantly enhanced spectral resolution.
The study population will include approximately 1000 participants recruited from multiple ophthalmic clinics in Melbourne, Australia. Participants will be recruited across a range of normal ocular health and retinal disease states, including but not limited to diabetic retinopathy, glaucoma, and age-related macular degeneration.
Imaging will be performed at the Centre for Eye Research Australia (CERA) using two hyperspectral imaging systems: the Optina Diagnostics Metabolic Hyperspectral Retinal Camera and a prototype hyperspectral camera developed at CERA. Both systems acquire rapid sequential retinal images across visible to near-infrared wavelengths. The Optina device provides a field of view of approximately 26 degrees and uses a tunable supercontinuum light source, while the CERA prototype uses LED-based illumination with optical filtering and provides a field of view of approximately 35 degrees.
Participants may undergo pharmacological pupil dilation prior to imaging to improve image quality. Each study visit will last approximately 60 minutes, including dilation and imaging procedures.
Image data will undergo registration and processing to correct for eye movement and system response, enabling extraction of pixel-level spectral signatures. Computational analysis methods will be developed to identify and quantify retinal and choroidal features and to explore associations between spectral signatures and structural or functional measures of disease.
The primary objectives are to optimise hyperspectral imaging acquisition protocols for retinal and optic nerve structures, to determine whether spectral signatures associated with retinal pathology can be detected using hyperspectral imaging, and to assess whether these spectral changes correlate with clinical measures of disease severity.
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 cohort | Experimental | Device: Hyperspectral retinal imagingParticipants undergo non-invasive hyperspectral retinal imaging of the fundus using two imaging systems: the Optina Diagnostics Metabolic Hyperspectral Retinal Camera and a prototype hyperspectral camera developed at the Centre for Eye Research Australia. Imaging is performed following pharmacological pupil dilation (mydriasis) as per standard ophthalmic procedure. The intervention involves multi-wavelength retinal image acquisition across visible to near-infrared spectra, similar in experience to conventional fundus photography but with sequential hyperspectral capture. Participants attend a single study visit of approximately 60 minutes, with optional repeat imaging visits on a voluntary basis for longitudinal data collection. No investigational drugs or therapeutic procedures are administered as part of the imaging intervention. Data collected includes hyperspectral retinal and choroidal image datasets for subsequent computational and spectroscopic analysis |
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 study imaging sessions
- Participants with healthy eyes or diagnosed retinal/optic nerve disease (including but not limited to diabetic retinopathy, glaucoma, and age-related macular degeneration)
- Adequate media clarity to permit retinal imaging as determined by investigator
Key exclusion criteria (5 listed)
- Inability to provide informed consent
- Known history of narrow anterior chamber angles or risk of acute angle closure where pupil dilation is contraindicated
- Ocular media opacities preventing adequate retinal imaging (e.g., dense cataract, severe corneal opacity, vitreous hemorrhage)
- Any condition that, in the opinion of the investigator, would make participation unsafe or compromise study data quality
- Allergy or contraindication to pharmacologic mydriatic agents used for pupil dilation
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 retinal imagingAlso: Optina Metabolic Hyperspectral Retinal Camera, CERA hyperspectral retinal cameraParticipants undergo non-invasive hyperspectral retinal imaging of the fundus using hyperspectral imaging devices that acquire sequential retinal images across multiple wavelengths (visible to near-infrared spectrum). Two devices may be used: the Optina Diagnostics Metabolic Hyperspectral Retinal Camera and a prototype hyperspectral camera developed at the Centre for Eye Research Australia. Imaging is performed following pharmacological pupil dilation (mydriasis) where required, and is similar in procedure to standard fundus photography, with the difference that multiple spectral channels (typically >25 and up to ~90 wavelengths) are captured in rapid sequence to generate a hyperspectral image dataset ("hypercube"). The intervention is non-invasive, does not involve radiation or therapeutic treatment, and is used solely for retinal and choroidal imaging data acquisition for research analysis of structural and spectroscopic retinal features. | Device | Hyperspectral retinal imaging cohort |
Primary outcome
Optimisation and characterisation of hyperspectral retinal imaging spectral signatures in normal and diseased eyes
Time frame: Single study visit (approximately 60 minutes), with additional optional follow-up imaging visits for longitudinal data collection where applicable.
To determine whether hyperspectral retinal imaging can reliably detect and characterise spectroscopic signatures associated with retinal and optic nerve structures in healthy participants and in participants with retinal diseases. This includes assessment of whether distinct spectral features can be identified and differentiated between normal retinal tissue and pathological retinal or optic nerve tissue, and evaluation of image quality and spectral signal consistency across imaging conditions and devices.
Results and safety
The study was stopped early (reason given: This study has been transferred to the Human Research Ethics Committee of St Vincent's Hospital Melbourne.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: Undecided. The plan for sharing individual participant data (IPD) has not yet been finalised. Given the exploratory and image-based nature of this study, which involves large hyperspectral retinal imaging datasets and ongoing development of analysis methods, decisions regarding data sharing will depend on the completion of primary analyses, ethical approvals, and institutional data governance requirements. The feasibility of de-identification and appropriate data access frameworks is currently 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperspectral retinal imaging in people with Retinal Disease, run by Center for Eye Research 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: stopped early, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was stopped early (reason given: This study has been transferred to the Human Research Ethics Committee of St Vincent's Hospital Melbourne.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimisation and characterisation of hyperspectral retinal imaging spectral signatures in normal and diseased eyes (time frame: Single study visit (approximately 60 minutes), with additional optional follow-up imaging visits for longitudinal data collection where applicable.). 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 15 Apr 2026.