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 range
18 Years – 74 Years
Sex
ALL
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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