Images Acquisition
DeviceAcquisition of useable video images
NCT Number: NCT06989996
Prospective, interventional, non-randomized, open-label study, multi-center, Gehan-designed study with sequential inclusions in each subgroup, ranging from 4 subjects to a maximum 37 subjects per subgroup included
Trial opening soon.
Get Notified18 year–74 year
All sexes
Interventional
Not applicable
Retinal perfusion can be affected by a number of local or general pathologies; however, there is currently no commercially available device to provide accurate measurements of retinal blood flow. The company Quantel Medical is developing a medical imaging device HoloDoppler (hereinafter referred to as the "HoloDoppler system"). system. In order to better define its medical utility, we aim to evaluate its reproducibility and accuracy in healthy subjects and those with conditions that may affect ocular blood flow.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Criteria common to both populations ( patients and healthy volunteers) :
Criteria for healthy volunteers :
No ocular or systemic disease deemed to affect ocular circulation by an investigator
Specific criteria for patients:
Exclusion criteria
Acquisition of useable video images
Time frame: 15 minutes
Evaluate the feasibility of retinal blood flow measurement with HoloDoppler imaging
Time frame: 15 minutes
Determine the reproducibility of retinal blood flow measurements with holodoppler at 15 minutes with the same operator and two different operators
This is an evaluation of image quality in terms of operation according to the following scheme.
Quality assessment:
If no, tick yes, below and fill in the cause:
Insufficient quality: ☒ yes ☐ no
Cause:
Time frame: 15 minutes
evaluate the accuracy of measurements or assessments by different operators the HoloDoppler system
Contact information is provided by the study sponsor or research team.
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Other
Acronym: HoLoEye
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