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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Ocular Disease | Experimental | Holodoppler Imaging, Acquisition of useable video images |
|
| participants without Ocular Disease | Active Comparator | Holodoppler Imaging, Acquisition of useable video images |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Images Acquisition | Device | Acquisition of useable video images |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of blood flow monitoring | Evaluate the feasibility of retinal blood flow measurement with HoloDoppler imaging | 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:
| 15 minutes |
| statistical precision measurements by intra-class coefficient (ICC) | evaluate the accuracy of measurements or assessments by different operators the HoloDoppler system | 15 minutes |
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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:
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:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nabil BROUK | Contact | 00 33 1 40 02 11 44 | nbrouk@15-20.fr |
| Name | Affiliation | Role |
|---|---|---|
| Michel PAQUES | Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts | Principal Investigator |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D016893 | Carotid Stenosis |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D002340 | Carotid Artery Diseases |
| D002561 | Cerebrovascular Disorders |
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| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |