Study of Human Ocular Hemodynamics by Holography Dopple (NCT06989996) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Study of Human Ocular Hemodynamics by Holography Dopple
148 participantsStarted 2025-06
Plain-language 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 subgroup included
Who can participate
Age range18 Years – 74 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 les…
What they're measuring
1
Feasibility of blood flow monitoring
Timeframe: 15 minutes
2
Assessment of the reproducibility of blood flow measurements
Timeframe: 15 minutes
3
statistical precision measurements by intra-class coefficient (ICC)
Timeframe: 15 minutes
Trial details
NCT IDNCT06989996
SponsorCentre Hospitalier National d'Ophtalmologie des Quinze-Vingts