Study of Human Ocular Hemodynamics by Holography Dopple
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-74
SponsorCentre Hospitalier National d'Ophtalmologie des Quinze-Vingts
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age ≥ 18 years and < 75 years;
Having received informed information about the study and having signed a consent to participate in the study;
Affiliated or covered by social security
Subjects usually followed at one of the recruiting centers;
Disqualifiers
Persons covered by articles L1121-5 to L1121-8 of the CSP (all protected persons: pregnant women, parturients, nursing mothers, persons deprived of their liberty by judicial decision or administrative decision, minors, and persons under legal protection: guardianship or curatorship);
Women of childbearing age not using an effective method of contraception, or positive pregnancy test (blood or urine);
Participants allergic to tropicamide when using pupillary dilatation;
Inability of the subject to maintain a stable sitting position for research procedures;
Trial design
Design model
Parallel
Treatments tested in this trial
Images Acquisition
DeviceAcquisition of useable video images
Treatment groups
148 Participants
are divided into 2 treatment groupsGroup A: Patients with Ocular DiseaseExperimental treatment 1 intervention
Group B: participants without Ocular DiseaseActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of blood flow monitoring
Evaluate the feasibility of retinal blood flow measurement with HoloDoppler imaging
Time frame
15 minutes2
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 minutes3
statistical precision measurements by intra-class coefficient (ICC)
evaluate the accuracy of measurements or assessments by different operators the HoloDoppler system
Time frame
15 minutesLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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