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

NCT ID: NCT06644196

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 123 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-08
• Study Completion Date: 2026-11-07

Brief 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.

Conditions

Vessels of the Eye Fundus

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Acquisition 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

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raphaël Lejoyeux, Dr

Role: PRINCIPAL_INVESTIGATOR

Hôpital Fondation Adolphe de Rothschild

Locations

Hôpital Fondation A. de Rothschild

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Amélie Yavchitz

Role: CONTACT

ayavchitz@for.paris

33 148036454

Facility Contacts

Raphaël Lejoyeux, Dr

Role: primary

rlejoyeux@for.paris

(0)148036437 ext. +33

Other Identifiers

SBN_2022_9

Identifier Type: -

Identifier Source: org_study_id