Clinical trial NCT06989996: Study of Human Ocular Hemodynamics by Holography Dopple
Official title: Study of Human Ocular Hemodynamics by Holography Dopple
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Glaucoma
Retinal Vascular Disorder
Keywords: glaucoma
pachychoroid,
carotid stenosis
Lead sponsor: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Sponsor class: OTHER
First posted: 2025-05-25
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * Patients wirhs ocular disease: patients with glaucoma and patients with choroidal disease
* Participants without ocular disease: healthy volunteers and patients with carotid stenosis
Primary purpose: OTHER

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 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.

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.

Primary outcomes:
measure: Feasibility of blood flow monitoring
timeFrame: 15 minutes
measure: Assessment of the reproducibility of blood flow measurements
timeFrame: 15 minutes
measure: statistical precision measurements by intra-class coefficient (ICC)
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
name: Michel PAQUES
role: PRINCIPAL_INVESTIGATOR
References: