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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06644196
Acronym
IREDO
Enrollment
123
Registered
2024-10-16
Start date
2024-11-08
Completion date
2026-11-07
Last updated
2025-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vessels of the Eye Fundus

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.

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

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild
Lead SponsorNETWORK

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Describe the usability of acquisitions (images/videos) of retinal and choroidal vascularization with holographic laser Doppler.Day0Acquisitions (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.

Countries

France

Contacts

Primary ContactAmélie Yavchitz
ayavchitz@for.paris33 148036454

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026