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
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
148
Acquisition of useable video images
Feasibility of blood flow monitoring
Evaluate the feasibility of retinal blood flow measurement with HoloDoppler imaging
Time frame: 15 minutes
Assessment of the reproducibility of blood flow measurements
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: \- Sufficient quality : Yes Or No If no, tick yes, below and fill in the cause: Insufficient quality: ☒ yes ☐ no Cause: * Technical problem Or * Patient-related problem (inability to fix, or comply with procedure, etc.).
Time frame: 15 minutes
statistical precision measurements by intra-class coefficient (ICC)
evaluate the accuracy of measurements or assessments by different operators the HoloDoppler system
Time frame: 15 minutes
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