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NCT Number: NCT06989996

Study of Human Ocular Hemodynamics by Holography Dopple

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Images Acquisition

Device

Acquisition of useable video images

Primary outcomes

  1. Feasibility of blood flow monitoring

    Time frame: 15 minutes

    Evaluate the feasibility of retinal blood flow measurement with HoloDoppler imaging

  2. Assessment of the reproducibility of blood flow measurements

    Time frame: 15 minutes

    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.).
  3. statistical precision measurements by intra-class coefficient (ICC)

    Time frame: 15 minutes

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

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Other

Registry information

Acronym: HoLoEye

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 25, 2025
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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