Study of Human Ocular Hemodynamics by Holography Dopple

NCT ID: NCT06989996

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2028-06-30

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.

Conditions

Glaucoma; Retinal Vascular Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patients with Ocular Disease

Holodoppler Imaging, Acquisition of useable video images

Group Type: EXPERIMENTAL

Images Acquisition

Intervention Type: DEVICE

Acquisition of useable video images

participants without Ocular Disease

Holodoppler Imaging, Acquisition of useable video images

Group Type: ACTIVE_COMPARATOR

Images Acquisition

Intervention Type: DEVICE

Acquisition of useable video images

Interventions

Images Acquisition

Acquisition of useable video images

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michel PAQUES

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Central Contacts

Nabil BROUK

Role: CONTACT

nbrouk@15-20.fr

00 33 1 40 02 11 44

Other Identifiers

P24-02

Identifier Type: -

Identifier Source: org_study_id