NCT06644196 Creation of a Database of Images of the Eye With the Holographic Doppler Laser
| NCT ID | NCT06644196 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondation Ophtalmologique Adolphe de Rothschild |
| Condition | Vessels of the Eye Fundus |
| Study Type | OBSERVATIONAL |
| Enrollment | 123 participants |
| Start Date | 2024-11-08 |
| Primary Completion | 2026-11-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 123 participants in total. It began in 2024-11-08 with a primary completion date of 2026-11-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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).
Contact & Investigator
Raphaël Lejoyeux, Dr
PRINCIPAL INVESTIGATOR
Hôpital Fondation Adolphe de Rothschild
Frequently Asked Questions
Who can join the NCT06644196 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Vessels of the Eye Fundus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06644196 currently recruiting?
Yes, NCT06644196 is actively recruiting participants. Contact the research team at ayavchitz@for.paris for enrollment information.
Where is the NCT06644196 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT06644196 clinical trial?
NCT06644196 is sponsored by Fondation Ophtalmologique Adolphe de Rothschild. The principal investigator is Raphaël Lejoyeux, Dr at Hôpital Fondation Adolphe de Rothschild. The trial plans to enroll 123 participants.