Clinical trial NCT06644196: Creation of a Database of Images of the Eye with the Holographic Doppler Laser
Official title: Creation of a Database of Images of the Eye with the Holographic Doppler Laser
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vessels of the Eye Fundus
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2024-10-16
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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).

Primary outcomes:
measure: Describe the usability of acquisitions (images/videos) of retinal and choroidal vascularization with holographic laser Doppler.
timeFrame: Day0
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Fondation A. de Rothschild
Study officials:
References: