Normal EyesNCT07338461
High Resolution Imaging OCT Study
A study testing Autofluorescence Imaging, Infrared reflectance imaging and OCT imaging in people with Normal Eyes and Age Related Macular Degeneration, run by Heidelberg Engineering GmbH at 1 site in Italy.
Trial summary
The goal of this pilot study is to compare image quality between the investigational devices (R1 and HighRes OCT) and the SPECTRALIS (cleared) in adult participants with normal and/or pathology eyes. Participants will be imaged with different imaging modalities and scan protocols on all study devices. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Normal Eyes, Age Related Macular Degeneration, Diabetic Retinopathy
- What is being tested?
- Autofluorescence Imaging, Infrared reflectance imaging and OCT imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteItaly
- Study dates
- 13 Mar 2026to 28 Mar 2027
- 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
- All Able and willing to undergo the test procedures, give consent, and to follow instructions.
- Signed informed consent Age ≥ 18 years
- Healthy Subjects without uncontrolled systemic conditions, as determined by the investigator Subjects without ocular disease, as determined by the investigator Corrected visual acuity ≥ 20/40 No reported history of ocular surgical intervention (except for refractive or cataract surgery)
- Age-related macular degeneration Subjects with a diagnosis of AMD as determined by the investigator, either early-intermediate, atrophic, or neovascular
- Diabetic retinopathy Subjects with a diagnosis of diabetic retinopathy as determined by the investigator
- Disease with expected altered autofluorescence pattern Subjects with a disease that can be expected to be associated with altered autofluorescence patterns as determined by the investigator
Who cannot join
- Subjects unable to read or write
- Subjects with ocular media not sufficiently clear to obtain acceptable study-related imaging
- Subjects who cannot tolerate the imaging procedures
- History of photosensitive epilepsy
- Vulnerable subjects, i.e., individuals with lack of or loss of autonomy due to immaturity or through mental disability, persons in nursing homes, impoverished persons, subjects in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Clinical Trials contact
Italy1 site, 1 recruiting
- Recruiting
Department of Biomedical and Clinical Sciences, Luigi Sacco Hospital, University of Milan
Milan, 20157
Mariano Cozzi, MD, +39 0239042666, Mariano.cozzi@unimi.it
About this study
Official title: High Resolution Imaging OCT Pilot Study
The goal of this pilot study is to compare image quality between the investigational devices (R1 and HighRes OCT) and the SPECTRALIS (cleared) in adult participants with normal and/or pathology eyes.
Participants will be imaged with different imaging modalities and scan protocols on all study devices.
- Conditions
- Normal Eyes, Age Related Macular Degeneration, Diabetic Retinopathy, Eyes With Retinal Diseases
- Being tested
- Autofluorescence Imaging, Infrared reflectance imaging, OCT imaging, OCTA imaging
- Medical subject headings
- Macular Degeneration, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autofluorescence ImagingDevice
Autofluorescence imaging with blue and green light and, multicolor imaging
Infrared reflectance imagingDevice
Infrared reflectance imaging, 30° Field of View
OCT imagingDevice
OCT Imaging Volume and Line Scans
OCTA imagingDevice
OCT Angiography, volume and SCOUT scan
| Study group | Role | What they receive |
|---|---|---|
| Investigational device R1 | Experimental | Imaging with the investigational device R1 Receives: Device: Autofluorescence Imaging; Device: Infrared reflectance imaging; Device: OCT imaging; Device: OCTA imaging |
| HighRes OCT | Experimental | Imaging with the investigational device HighRes OCT Receives: Device: Autofluorescence Imaging; Device: Infrared reflectance imaging; Device: OCT imaging; Device: OCTA imaging |
| SPECTRALIS | Other | Imaging with the approved device SPECTRALIS Receives: Device: Autofluorescence Imaging; Device: Infrared reflectance imaging; Device: OCT imaging; Device: OCTA imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
cSLO Image quality grading
Good: Good focus, even illumination, optimal exposure Average: The image is of sub-optimal quality, where there are issues with focus, illumination, or exposure, but the image still allows assessment of clinically relevant content Poor: Clinically relevant features are not visible, images are not clinically useful
Measured: 6 months after image acquisition
Visability of key anatomical structures
Visibility of
OCT image:
- Difference in reflectivity between the outer retino-choroidal complex and vitreous
- The vitreo-retinal interface
- Difference in reflectivity between retinal nerve fiber layer and vitreous
- Difference in reflectivity between plexiform layer and vitreous
- Multiple layers within the outer retino-choroidal complex
- The ganglion cell layer
- Difference in reflectivity between outer nuclear layer and vitreous
- External limiting membrane
- Choroidal/scleral interface
OCTA image:
- Foveal avascular zone
- Large vessels: 1st order vasculature, if applicable
- Medium vessels: 2nd and 3rd order vasculature
- Small vessels: between 3rd order vasculature and end capillaries
- End capillaries
Measured: 6 months after image acquisition
Secondary outcomes (1)
Safety Monitoring
Observation of possible adverse events
Measured: from enrollment to study completion (expected 1 year after initiation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start13 Mar 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion28 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal EyesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 97 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg Engineering GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mariano Cozzi, MD, Principal investigator, University of Milan, Department of Biomedical and Clinical Sciences, Luigi Sacco Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07338461
- Sponsor's protocol ID
- R-2025-1
- Status last verified
- Nov 2025
- First submitted
- 25 Nov 2025
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Resolution Imaging OCT Pilot Study
- ClinicalTrials.gov ID
- NCT07338461
- Acronym / sponsor ID
- R-2025-1
- Conditions
- Normal Eyes, Age Related Macular Degeneration, Diabetic Retinopathy, Eyes With Retinal Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 97 participants (estimated)
- Lead sponsor
- Heidelberg Engineering GmbHIndustry (pharma, biotech, devices)
- Study start
- 13 Mar 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 28 Mar 2027 (estimated)
- First posted
- 13 Jan 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.
The goal of this pilot study is to compare image quality between the investigational devices (R1 and HighRes OCT) and the SPECTRALIS (cleared) in adult participants with normal and/or pathology eyes.
Participants will be imaged with different imaging modalities and scan protocols on all study devices.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Investigational device R1 | Experimental | Device: Autofluorescence Imaging, Device: Infrared reflectance imaging, Device: OCT imaging, Device: OCTA imagingImaging with the investigational device R1 |
| HighRes OCT | Experimental | Device: Autofluorescence Imaging, Device: Infrared reflectance imaging, Device: OCT imaging, Device: OCTA imagingImaging with the investigational device HighRes OCT |
| SPECTRALIS | Other | Device: Autofluorescence Imaging, Device: Infrared reflectance imaging, Device: OCT imaging, Device: OCTA imagingImaging with the approved device SPECTRALIS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All Able and willing to undergo the test procedures, give consent, and to follow instructions.
- Signed informed consent Age ≥ 18 years
- Healthy Subjects without uncontrolled systemic conditions, as determined by the investigator Subjects without ocular disease, as determined by the investigator Corrected visual acuity ≥ 20/40 No reported history of ocular surgical intervention (except for refractive or cataract surgery)
- Age-related macular degeneration Subjects with a diagnosis of AMD as determined by the investigator, either early-intermediate, atrophic, or neovascular
- Diabetic retinopathy Subjects with a diagnosis of diabetic retinopathy as determined by the investigator
Key exclusion criteria (5 listed)
- Subjects unable to read or write
- Subjects with ocular media not sufficiently clear to obtain acceptable study-related imaging
- Subjects who cannot tolerate the imaging procedures
- History of photosensitive epilepsy
- Vulnerable subjects, i.e., individuals with lack of or loss of autonomy due to immaturity or through mental disability, persons in nursing homes, impoverished persons, subjects in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent.
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 |
|---|---|---|
| Autofluorescence ImagingAutofluorescence imaging with blue and green light and, multicolor imaging | Device | HighRes OCT, Investigational device R1, SPECTRALIS |
| Infrared reflectance imagingInfrared reflectance imaging, 30° Field of View | Device | HighRes OCT, Investigational device R1, SPECTRALIS |
| OCT imagingOCT Imaging Volume and Line Scans | Device | HighRes OCT, Investigational device R1, SPECTRALIS |
| OCTA imagingOCT Angiography, volume and SCOUT scan | Device | HighRes OCT, Investigational device R1, SPECTRALIS |
Primary outcome
cSLO Image quality grading
Time frame: 6 months after image acquisition
Good: Good focus, even illumination, optimal exposure Average: The image is of sub-optimal quality, where there are issues with focus, illumination, or exposure, but the image still allows assessment of clinically relevant content Poor: Clinically relevant features are not visible, images are not clinically useful
Visability of key anatomical structures
Time frame: 6 months after image acquisition
Visibility of OCT image: 1. Difference in reflectivity between the outer retino-choroidal complex and vitreous 2. The vitreo-retinal interface 3. Difference in reflectivity between retinal nerve fiber layer and vitreous 4. Difference in reflectivity between plexiform layer and vitreous 5. Multiple layers within the outer retino-choroidal complex 6. The ganglion cell layer 7. Difference in reflectivity between outer nuclear layer and vitreous 8. External limiting membrane 9. Choroidal/scleral interface OCTA image: 1. Foveal avascular zone 2. Large vessels: 1st order vasculature, if applicable 3. Medium vessels: 2nd and 3rd order vasculature 4. Small vessels: between 3rd order vasculature and end capillaries 5. End capillaries
1 secondary outcome
Safety Monitoring
Time frame: from enrollment to study completion (expected 1 year after initiation)
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 26 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Clinical Trials contact
Mariano Cozzi, MD principal investigator
University of Milan, Department of Biomedical and Clinical Sciences, Luigi Sacco Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autofluorescence Imaging, Infrared reflectance imaging and OCT imaging in people with Normal Eyes and Age Related Macular Degeneration, run by Heidelberg Engineering GmbH at 1 site in Italy.
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 6 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 26 Aug 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 Italy. 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 Aike T. Schweda, PhD (+49 62216463387, Aike.Schweda@HeidelbergEngineering.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cSLO Image quality grading (time frame: 6 months after image acquisition). The study lists 2 primary outcomes in all. 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 26 Aug 2026.