Status:
NOT_YET_RECRUITING
Study of Human Ocular Hemodynamics by Holography Dopple
Lead Sponsor:
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Conditions:
Glaucoma
Retinal Vascular Disorder
Eligibility:
All Genders
18-74 years
Phase:
NA
Brief Summary
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 subg...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT06989996
Start Date
June 1 2025
End Date
June 1 2028
Last Update
May 25 2025
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