Informations générales (source: ClinicalTrials.gov)

NCT06644196 En recrutement IDF
Creation of a Database of Images of the Eye with the Holographic Doppler Laser (IREDO)
Observational
Fondation Ophtalmologique Adolphe de Rothschild (Voir sur ClinicalTrials)
novembre 2024
novembre 2025
05 avril 2025
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.

Etablissements

Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
HOPITAL FONDATION A. DE ROTHSCHILD Sophie Bonnin En recrutement IDF Contact (sur clinicalTrials)

Critères

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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).



- 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).