GlaucomaHoLoEyeNCT06989996
Study of Human Ocular Hemodynamics by Holography Dopple
A study testing Images Acquisition in people with Glaucoma and Retinal Vascular Disorder, run by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Retinal Vascular Disorder
- What is being tested?
- Images Acquisition
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- No sites listed yet
- Study dates
- Jun 2025to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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:
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
Read the 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
- Being tested
- Images Acquisition
- Keywords
- glaucoma, pachychoroid,, carotid stenosis
- Medical subject headings
- Glaucoma, Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Images AcquisitionDevice
Acquisition of useable video images
| Study group | Role | What they receive |
|---|---|---|
| Patients with Ocular Disease | Experimental | Holodoppler Imaging, Acquisition of useable video images Receives: Device: Images Acquisition |
| participants without Ocular Disease | Active comparator | Holodoppler Imaging, Acquisition of useable video images Receives: Device: Images Acquisition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of blood flow monitoring
Evaluate the feasibility of retinal blood flow measurement with HoloDoppler imaging
Measured: 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.).
Measured: 15 minutes
statistical precision measurements by intra-class coefficient (ICC)
evaluate the accuracy of measurements or assessments by different operators the HoloDoppler system
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study startJun 2025 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel PAQUES, Principal investigator, Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06989996
- Sponsor's protocol ID
- P24-02
- Acronym
- HoLoEye
- Status last verified
- May 2025
- First submitted
- 2 May 2025
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Human Ocular Hemodynamics by Holography Dopple
- ClinicalTrials.gov ID
- NCT06989996
- Acronym / sponsor ID
- HoLoEye / P24-02
- Conditions
- Glaucoma, Retinal Vascular Disorder
- Keywords
- glaucoma, pachychoroid,, carotid stenosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Centre Hospitalier National d'Ophtalmologie des Quinze-VingtsUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Patients with Ocular Disease | Experimental | Device: Images AcquisitionHolodoppler Imaging, Acquisition of useable video images |
| participants without Ocular Disease | Active comparator | Device: Images AcquisitionHolodoppler Imaging, Acquisition of useable video images |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
- No ocular or systemic disease deemed to affect ocular circulation by an investigator
- Subjects usually followed at one of the recruiting centers;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Images AcquisitionAcquisition of useable video images | Device | Patients with Ocular Disease, participants without Ocular Disease |
Primary outcome
Feasibility of blood flow monitoring
Time frame: 15 minutes
Evaluate the feasibility of retinal blood flow measurement with HoloDoppler imaging
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.).
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michel PAQUES principal investigator
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Questions about this trial
What is this clinical trial studying?
A study testing Images Acquisition in people with Glaucoma and Retinal Vascular Disorder, run by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nabil BROUK (00 33 1 40 02 11 44, nbrouk@15-20.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of blood flow monitoring (time frame: 15 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.