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Clinical Trials/NCT06644196
NCT06644196
Recruiting
Not Applicable

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

Fondation Ophtalmologique Adolphe de Rothschild1 site in 1 country123 target enrollmentNovember 8, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Vessels of the Eye Fundus
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
Enrollment
123
Locations
1
Primary Endpoint
Describe the usability of acquisitions (images/videos) of retinal and choroidal vascularization with holographic laser Doppler.
Status
Recruiting
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 8, 2024
End Date
November 7, 2026
Last Updated
4 months ago
Study Type
Observational
Sex
All

Investigators

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).

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).

Outcomes

Primary Outcomes

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

Time Frame: Day0

Acquisitions (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.

Study Sites (1)

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