Study of Human Ocular Hemodynamics by Holography Dopple

NCT06989996 | Not Yet Recruiting

• 1 other identifier: P24-02
• Study Type: interventional
• Target: 148
• Locations: 0 countries
• Sites: N/A

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

Conditions

Glaucoma; Retinal Vascular Disorder

Keywords

glaucoma; pachychoroid,; carotid stenosis

Outcome Measures

Primary Outcomes (3)

• Feasibility of blood flow monitoring

  Evaluate the feasibility of retinal blood flow measurement with HoloDoppler imaging

  15 minutes

• Assessment of the reproducibility of blood flow measurements

  Determine the reproducibility of retinal blood flow measurements with holodoppler at 15 minutes with the same operator and two different operators This is an evaluation of image quality in terms of operation according to the following scheme. Quality assessment: \- Sufficient quality : Yes Or No If no, tick yes, below and fill in the cause: Insufficient quality: ☒ yes ☐ no Cause: * Technical problem Or * Patient-related problem (inability to fix, or comply with procedure, etc.).

  15 minutes

• statistical precision measurements by intra-class coefficient (ICC)

  evaluate the accuracy of measurements or assessments by different operators the HoloDoppler system

  15 minutes

Study Arms (2)

Patients with Ocular Disease

EXPERIMENTAL

Holodoppler Imaging, Acquisition of useable video images

Device: Images Acquisition

participants without Ocular Disease

ACTIVE COMPARATOR

Holodoppler Imaging, Acquisition of useable video images

Device: Images Acquisition

Interventions

Images Acquisition DEVICE

Acquisition of useable video images

Patients with Ocular Disease; participants without Ocular Disease

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts: lead

MeSH Terms

Conditions

Glaucoma; Carotid Stenosis

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Michel PAQUES

  Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nabil BROUK

CONTACT

00 33 1 40 02 11 44; nbrouk@15-20.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: * Patients wirhs ocular disease: patients with glaucoma and patients with choroidal disease * Participants without ocular disease: healthy volunteers and patients with carotid stenosis

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: May 25, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: May 25, 2025

Record last verified: 2025-05