Creation of a Database of Images of the Eye With the Holographic Doppler Laser (IREDO)

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 Overview

• Status: Recruiting
• Conditions: Vessels of the Eye Fundus
• Intervention / Treatment: Device: Acquisition of images/videos of the bilateral fundus with the holographic doppler laser

• Study Type: Observational
• Enrollment (Estimated): 123

Contacts and Locations

• Study Contact: Name: Amélie Yavchitz; Phone Number: 33 148036454; Email: ayavchitz@for.paris

Study Locations

• France
  • Paris, France, 75019
    • Recruiting
    • Hôpital Fondation A. de Rothschild
    • Contact: Raphaël Lejoyeux, Dr; Phone Number: +33 (0)148036437; Email: rlejoyeux@for.paris
    • Principal Investigator: Raphaël Lejoyeux, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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.

Description

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:

• 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).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day0

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
• Investigators: Principal Investigator: Raphaël Lejoyeux, Dr, Hôpital Fondation Adolphe de Rothschild

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2024
• Primary Completion (Estimated): November 7, 2026
• Study Completion (Estimated): November 7, 2026

Study Registration Dates

• First Submitted: October 14, 2024
• First Submitted That Met QC Criteria: October 14, 2024
• First Posted (Actual): October 16, 2024

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: SBN_2022_9

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No