Vessels of the Eye FundusIREDONCT06644196
Creation of a Database of Images of the Eye With the Holographic Doppler Laser
An observational study of Vessels of the Eye Fundus, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Many retinal pathologies are of vascular origin. In order to better understand their pathophysiology and make an accurate diagnosis, it is essential to visualise and quantify blood flow. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vessels of the Eye Fundus
- What is being tested?
- Acquisition of images/videos of the bilateral fundus with the holographic doppler laser
- Type of treatment
- Medical device
- How many people
- 123 participants
- Where
- 1 siteFrance
- Study dates
- 8 Nov 2024to 7 Nov 2026
- Phase
- Observational
- 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
Study population: Participants will be recruited from ophthalmology consultations , or for participants with no ocular pathology, from staff, patients followed for a non-ophthalmological pathology or patient companions.
Who may be able to join
- For all participants:
- Age ≥ 18 years
- Having received informed information about the study and having signed a consent to participate in the study
- Affiliated or beneficiary of social insurance
- For participants with no known ocular pathology:
- No known ocular pathology other than a refractive disorder
Show all 12Show fewer
- For patients with optic nerve pathology:
- Patient undergoing ophthalmology consultation for optic nerve pathology in at least one eye (examples: glaucoma, optic neuritis, hereditary optic nerve diseases)
- For patients with retinal and/or choroidal pathology:
- Patients undergoing ophthalmology consultations for retinal and/or choroidal pathology in at least one eye (examples: diabetic retinopathy, age-related macular degeneration).
- For patients with retinal vascular pathology:
- Patient undergoing ophthalmology consultation for retinal vascular pathology in at least one eye (e.g. central retinal artery occlusion, central retinal vein occlusion, ocular ischemia syndrome).
Who cannot join
- Inability to maintain a stable sitting position
- Contraindications to holographic doppler laser :
- implanted medical electronic device (pacemaker or other)
- history of photosensitivity.
- received photo-dynamic therapy (PDT) within the last 3 months.
- viral conjunctivitis or any other infectious disease.
- skin lesions on the neck or forehead, not allowing contact with a chin strap
- patients at high risk of damage from optical radiation (e.g. aphakic patients, or patients with reduced sensitivity to light due to disease of the back of the eye).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Fondation A. de Rothschild
Paris, 75019
Raphaël Lejoyeux, Dr, (0)148036437 ext. +33, rlejoyeux@for.paris
Raphaël Lejoyeux, Dr
About this study
Many retinal pathologies are of vascular origin. In order to better understand their pathophysiology and make an accurate diagnosis, it is essential to visualise and quantify blood flow. The holographic Doppler laser (LDH) is a new medical device currently being developed by physics researchers at the Institut Langevin. The 1st prototype of this device is currently being used as part of research involving humans with minimal risks and constraints at the Hôpital National de la Vision des Quinze-Vingts (NCT04129021).
In order to better visualise, understand and quantify the vascular anomalies suspected in the fundus of patients undergoing ophthalmology treatment , we would like to acquire images/videos with a 2nd LDH prototype, within the ophthalmology clinical investigation platform at the Hôpital Fondation Adolphe de Rothschild.
- Conditions
- Vessels of the Eye Fundus
- Being tested
- Acquisition of images/videos of the bilateral fundus with the holographic doppler laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acquisition of images/videos of the bilateral fundus with the holographic doppler laserDevice
Acquisition of images/videos of the bilateral fundus with the holographic Doppler laser
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe the usability of acquisitions (images/videos) of retinal and choroidal vascularization with holographic laser Doppler.
Acquisitions (images/videos) will be considered usable if they allow :
- (1) The ophthalmologist can visually distinguish arterial and venous vascular networks.
- (2) The device measures arterial and venous blood flow.
Measured: Day0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start8 Nov 2024
- Primary completion7 Nov 2026 (estimated)
- Study completion7 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vessels of the Eye FundusStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 123 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Raphaël Lejoyeux, Dr, Principal investigator, Hôpital Fondation Adolphe de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06644196
- Sponsor's protocol ID
- SBN_2022_9
- Acronym
- IREDO
- Status last verified
- Dec 2025
- First submitted
- 14 Oct 2024
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creation of a Database of Images of the Eye With the Holographic Doppler Laser
- ClinicalTrials.gov ID
- NCT06644196
- Acronym / sponsor ID
- IREDO / SBN_2022_9
- Conditions
- Vessels of the Eye Fundus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 123 participants (estimated)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 8 Nov 2024 (actual)
- Primary completion
- 7 Nov 2026 (estimated)
- Study completion
- 7 Nov 2026 (estimated)
- First posted
- 16 Oct 2024 (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.
Many retinal pathologies are of vascular origin. In order to better understand their pathophysiology and make an accurate diagnosis, it is essential to visualise and quantify blood flow. The holographic Doppler laser (LDH) is a new medical device currently being developed by physics researchers at the Institut Langevin. The 1st prototype of this device is currently being used as part of research involving humans with minimal risks and constraints at the Hôpital National de la Vision des Quinze-Vingts (NCT04129021).
In order to better visualise, understand and quantify the vascular anomalies suspected in the fundus of patients undergoing ophthalmology treatment , we would like to acquire images/videos with a 2nd LDH prototype, within the ophthalmology clinical investigation platform at the Hôpital Fondation Adolphe de Rothschild.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from ophthalmology consultations , or for participants with no ocular pathology, from staff, patients followed for a non-ophthalmological pathology or patient companions.
Key inclusion criteria (12 listed)
- Age ≥ 18 years
- Having received informed information about the study and having signed a consent to participate in the study
- Affiliated or beneficiary of social insurance
- No known ocular pathology other than a refractive disorder
- Patient undergoing ophthalmology consultation for optic nerve pathology in at least one eye (examples: glaucoma, optic neuritis, hereditary optic nerve diseases)
Key exclusion criteria (8 listed)
- Inability to maintain a stable sitting position
- Contraindications to holographic doppler laser :
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 |
|---|---|---|
| Acquisition of images/videos of the bilateral fundus with the holographic doppler laserAcquisition of images/videos of the bilateral fundus with the holographic Doppler laser | Device | – |
Primary outcome
Describe the usability of acquisitions (images/videos) of retinal and choroidal vascularization with holographic laser Doppler.
Time frame: Day0
Acquisitions (images/videos) will be considered usable if they allow : * (1) The ophthalmologist can visually distinguish arterial and venous vascular networks. * (2) The device measures arterial and venous blood flow.
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 10 Dec 2025.
Related trials for Vessels of the Eye Fundus
RecruitingObservational study
Pivotal Trial for an Automated AI-based System for Detection of Diabetic Retinopathy
Diabetic Retinopathy (DR)
RecruitingObservational study
Validation of the Artificial Intelligence Subsystem of the DDART Medical Device for the Automated Detection of Lesions Compatible With Diabetic Retinopathy in a Random Sample of Retinal Fundus Photographs
Diabetic Retinopathy
Recruiting
Single Session vs Multiple-Session Panretinal Photocoagulation for Treatment of Proliferative Diabetic Retinopathy
Proliferative Diabetic Retinopathy, Diabetic Retinopathy
RecruitingObservational study
A Clinical Study of Fundus OCTA for the Identification of CMD
Coronary Microvascular Disease
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.
Raphaël Lejoyeux, Dr principal investigator
Hôpital Fondation Adolphe de Rothschild
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vessels of the Eye Fundus, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
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 12 inclusion and 8 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 10 Dec 2025. 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 France. 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 Amélie Yavchitz (33 148036454, ayavchitz@for.paris), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe the usability of acquisitions (images/videos) of retinal and choroidal vascularization with holographic laser Doppler. (time frame: Day0). 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 10 Dec 2025.