Study of Human Ocular Hemodynamics by Holography Dopple
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Images Acquisition.
- Who it may be relevant to
- Registry conditions: Glaucoma, Retinal Vascular Disorder. Basic parameters: 18 years — 74 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Detailed description
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.
Interventions
- Device Images Acquisition
Acquisition of useable video images
Primary outcome measures
- Feasibility of blood flow monitoring [Time frame: 15 minutes]
- Assessment of the reproducibility of blood flow measurements [Time frame: 15 minutes]
- statistical precision measurements by intra-class coefficient (ICC) [Time frame: 15 minutes]
Eligibility criteria
Inclusion criteria
Criteria common to both populations ( patients and healthy volunteers) :
- 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
Criteria for healthy volunteers :
No ocular or systemic disease deemed to affect ocular circulation by an investigator
Specific criteria for patients:
- Subjects usually followed at one of the recruiting centers;
- Patients with chronic glaucoma, for whom a therapeutic modification is planned in the short term;
- Patients with carotid stenosis;
- Patients with choroidal pathology: pachychoroidism having led to pigment epithelium anomalies.
Exclusion criteria
- For all participants:
- 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;
- Temporary contraindication to HoloDoppler:
- Patient suffering from viral conjunctivitis or any other infectious disease;
- Patient with skin lesions on the neck or forehead, for which contact with a chin strap is not recommended.
- Impossibility of making acquisitions of interest (e.g. due to a pupil diameter that is too small, advanced cataracts, nystagmus, etc.).
- Wearing glasses or contact lenses to correct a refractive disorder is not considered a criterion for non-inclusion.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06989996 · P24-02