CClinicalTrials.gg
RecruitingNCT06644196IREDOUpdated Dec 10, 2025

Creation of a Database of Images of the Eye With the Holographic Doppler Laser

An observational study in Vessels of the Eye Fundus, sponsored by Fondation Ophtalmologique Adolphe de Rothschild. Recruiting at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-10.

Sponsored by Fondation Ophtalmologique Adolphe de Rothschild · Observational

From the registry’s dates

  • Started Nov 2024; still recruiting 1 year 11 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
123
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Vessels of the Eye Fundus
03

In context

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild is the lead sponsor of 311 studies on the registry; 77 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Inclusion criteria

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

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).

Exclusion criteria

Exclusion Criteria:

  • 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).
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
123 participants (estimated)
Patient registry
No

Interventions

  • DeviceAcquisition of images/videos of the bilateral fundus with the holographic doppler laser

    Acquisition of images/videos of the bilateral fundus with the holographic Doppler laser

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day0

07

Study locations

1 of 1 sites recruiting
  • Hôpital Fondation A. de Rothschild
    Paris, 75019, France
    • Raphaël Lejoyeux, Dr · Contact · rlejoyeux@for.paris · (0)148036437
    • Raphaël Lejoyeux, Dr · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06644196
Lead sponsor
Fondation Ophtalmologique Adolphe de Rothschild
Responsible party
Sponsor
First posted
Oct 16, 2024
Start date
Nov 8, 2024
Primary completion
Nov 7, 2026 (estimated)
Completion
Nov 7, 2026 (estimated)
Last update
Dec 10, 2025

Study contacts

Amélie Yavchitz
Contact
ayavchitz@for.paris
33 148036454
Raphaël Lejoyeux, Dr
principal investigator · Hôpital Fondation Adolphe de Rothschild

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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