GlaucomaAO-LDVNCT03525132
Study of the Retinal Vascularization by Laser Doppler Velocimetry Coupled With an Adaptive Optics Camera ( AO-LDV)
A study testing Laser Doppler Velocimetry + Optic Adaptative Camera in people with Glaucoma and Retinal Vein Occlusion, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The difficulty to measure blood flow in humans is connected with the necessity of using not invasive, reliable and reproducible techniques. There is several quantitative approaches to study eye blood flow which do not answer all these specifications. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Retinal Vein Occlusion
- What is being tested?
- Laser Doppler Velocimetry + Optic Adaptative Camera
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteFrance
- Study dates
- 18 Sep 2015to 18 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing and able to give written Informed Consent and to comply with the requirements of the study protocol
- Person affiliated to social security
- Age between 18 and 80 years
- Capable of focusing a target without ocular micro stuttering
- For healthy subject : absence of ocular and systemic pathology and no medical treatment
- For subject with glaucoma : Primitive open-angle glaucoma unilateral or bilateral. Visual field must be considerate as compatible and reliable with campimetric impairment known in glaucoma.
Show all 19Show fewer
- For subject wih retinal veinous occlusion : Retinal central vein occlusion or branch retinal vein occlusion medically confirmed with an eye fundus exam and fluorescein angiography.
- Non-inclusion Criteria:
- Subject mentioned in L1121-5 to L1121-8 article of French Health Code : pregnant women, women capable of child bearing without contraceptive measures, under-age subject, subject under juridic protection or not able to give informed consent, subject deprived of liberty
- Any systemic medication with action on intraocular pressure such as sympathomimetic and beta blocker
- Hypersensitivity to tropicamide or its derivatives or to any eye drops excipients
- Subject who do not want to take part to the study
- Subject participating to another clinical trial
- Subject who can't come back for follow up visits
- Subject with lenses and who can't stop wearing them for the study protocol
- Close or narrow anterior chamber angle
- For healthy subject : Ametropia > 3 diopter, subject with non evolutive or evolutive ocular pathology
- For subject with glaucoma : Ametropia > 3 diopter, secondary glaucoma, closed angle glaucoma, isolated intraocular hypertonia, eye surgery within 3 months before the beginning of the study, trabeculoplasty, filtration surgery, associated evolutive or non-evolutive ocular pathology
- For subject with retinal veinous occlusion : Ametropia > 3, associated evolutive or non-evolutive ocular pathology, patient already treated with intravitreal injection with anti-VEGF or dexamethasone implant (no older than 4 months)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Florent APTEL, PhD contact
anais ADOLLE contact
France1 site, 1 recruiting
- Recruiting
University Hospital Grenoble
Grenoble, 38043
Florent APTEL, MD, PhD
About this study
Official title: Study of the Retinal Vascularization by Laser Doppler Velocimetry Coupled With an Adaptive Optics Camera ( AO-LDV) in Healthy Subject and Subject Affected by Glaucoma or Retinal Venous Occlusion
The difficulty to measure blood flow in humans is connected with the necessity of using not invasive, reliable and reproducible techniques.
There is several quantitative approaches to study eye blood flow which do not answer all these specifications. The laser doppler velocimetry allows movement speed measures but not vessel diameter. Optical coherence tomography doppler allows a simultaneous diameter and speed of travel (movement) measures, but presents a limited spatial resolution and thereby not easily reproducible vessel diameter measures.
The investigators propose development of a technique allowing a simultaneous diameter and velocity measure of these vessels.
Read the detailed description
The eye blood flow plays a fundamental role in the eye physiology, insuring the metabolic contributions of various eye tissues, in particular those associated with the vision photochemical processes. Eye blood flow changes are involved in the physiopathology of several frequent eye diseases susceptible to lead to blindness (glaucoma,age-related macular degeneration, venous or arterial occlusions). Numerous systematic pathologies can also alter eye blood flow (diabetes, sleep apnea, arterial high blood pressure, inflammation).
The difficulty to measure blood flow in humans is connected with the necessity of using not invasive, reliable and reproducible techniques.
There is several quantitative approaches to study eye blood flow which do not answer all these specifications. The laser doppler velocimetry allows movement speed measures but not vessel diameter. Optical coherence tomography doppler allows a simultaneous diameter and speed of travel (movement) measures, but presents a limited spatial resolution and thereby not easily reproducible vessel diameter measures.
The investigators propose development of a technique allowing a simultaneous diameter and velocity measure of these vessels.
- Conditions
- Glaucoma, Retinal Vein Occlusion
- Being tested
- Laser Doppler Velocimetry + Optic Adaptative Camera
- Medical subject headings
- Glaucoma, Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser Doppler Velocimetry + Optic Adaptative CameraProcedure or surgery
Fluxometry measure while subject is sitting in front of the optic adaptative camera
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Experimental | 120 healthy subjects in the first session and 30 in the second Intervention : Laser Doppler Velocimetry + Optic Adaptative Camera Receives: Procedure: Laser Doppler Velocimetry + Optic Adaptative Camera |
| Glaucoma | Experimental | 60 subjects with glaucoma Intervention : Laser Doppler Velocimetry + Optic Adaptative Camera Receives: Procedure: Laser Doppler Velocimetry + Optic Adaptative Camera |
| Retinal vein occlusion | Experimental | 80 subjects with retinal vein occlusion including 40 with peripheric occlusion and 40 with central occlusion Intervention : Laser Doppler Velocimetry + Optic Adaptative Camera Receives: Procedure: Laser Doppler Velocimetry + Optic Adaptative Camera |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of total retinal blood flow in healthy subject
Total retinal blood flow measurement in healthy subject at rest
Measured: Day 0, Day 30 to Day 60
Secondary outcomes (7)
Repeatability and reproducibility of retinal blood flow measures intra and inter session
Coefficient of variation for Repeatability and Reproducibility (3 measures session every 5 minutes on the same day, repeated one or two months after)
Measured: Day 0, Day 30 to Day 60
Change of retinal blood flow in different ages subjects
Total retinal blood flow measurement in different ages subjects
Measured: Day 0, Day 30 to Day 60
Evaluation of the relation between retinal blood flow and vessel diameter
Retinal blood flow and diameter of principal vessels coming from the optic disc
Measured: Day 0, Day 30 to Day 60
Measure retinal blood flow in subject with glaucoma and compare results with healthy subjects
Total retinal blood flow measured in subjects with glaucoma and age- and sex-matched healthy subjects
Measured: Day 0
Measure retinal blood flow in subject with retinal vein occlusion and compare results with measurements made in ipsilateral non pathogenic vessels, controlateral vessels and healthy subjects.
Total blood flow compare to the controlateral eye and healthy subject data
Measured: Day 0, Month 1, Month 2, Month 3, Month 6
Retinal blood flow evaluation after 1, 2 and 3 months after the inclusion of subject with retinal vein occlusion
Partial retinal blood flow in a occluded temporal vein compare to a healthy ipsilateral temporal vein
Measured: Day 0, Month 1, Month 2, Month 3
Retinal blood flow evaluation after 1, 2, 3 and 6 months after intravitreal injection of aflibercept in subject treated for macular oedema as a complication of retinal vein occlusion
Retinal blood flow evolution will be evaluated regarding macular oedema and retinal ischaemia occurence
Measured: Day 0, Month 1, Month 2, Month 3, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2018
- Study start18 Sep 2015
- Primary completion18 Mar 2020 (estimated)
- Study completion18 Sep 2020 (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.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florent Aptel, PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03525132
- Sponsor's protocol ID
- 2014-A01353-44
- Acronym
- AO-LDV
- Status last verified
- Jun 2019
- First submitted
- 26 Apr 2018
- Last updated
- 17 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Retinal Vascularization by Laser Doppler Velocimetry Coupled With an Adaptive Optics Camera ( AO-LDV) in Healthy Subject and Subject Affected by Glaucoma or Retinal Venous Occlusion
- ClinicalTrials.gov ID
- NCT03525132
- Acronym / sponsor ID
- AO-LDV / 2014-A01353-44
- Conditions
- Glaucoma, Retinal Vein Occlusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 18 Sep 2015 (actual)
- Primary completion
- 18 Mar 2020 (estimated)
- Study completion
- 18 Sep 2020 (estimated)
- First posted
- 15 May 2018 (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.
The difficulty to measure blood flow in humans is connected with the necessity of using not invasive, reliable and reproducible techniques.
There is several quantitative approaches to study eye blood flow which do not answer all these specifications. The laser doppler velocimetry allows movement speed measures but not vessel diameter. Optical coherence tomography doppler allows a simultaneous diameter and speed of travel (movement) measures, but presents a limited spatial resolution and thereby not easily reproducible vessel diameter measures.
The investigators propose development of a technique allowing a simultaneous diameter and velocity measure of these vessels.
Detailed description
The eye blood flow plays a fundamental role in the eye physiology, insuring the metabolic contributions of various eye tissues, in particular those associated with the vision photochemical processes. Eye blood flow changes are involved in the physiopathology of several frequent eye diseases susceptible to lead to blindness (glaucoma,age-related macular degeneration, venous or arterial occlusions). Numerous systematic pathologies can also alter eye blood flow (diabetes, sleep apnea, arterial high blood pressure, inflammation).
The difficulty to measure blood flow in humans is connected with the necessity of using not invasive, reliable and reproducible techniques.
There is several quantitative approaches to study eye blood flow which do not answer all these specifications. The laser doppler velocimetry allows movement speed measures but not vessel diameter. Optical coherence tomography doppler allows a simultaneous diameter and speed of travel (movement) measures, but presents a limited spatial resolution and thereby not easily reproducible vessel diameter measures.
The investigators propose development of a technique allowing a simultaneous diameter and velocity measure of these vessels.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | Experimental | Procedure: Laser Doppler Velocimetry + Optic Adaptative Camera120 healthy subjects in the first session and 30 in the second Intervention : Laser Doppler Velocimetry + Optic Adaptative Camera |
| Glaucoma | Experimental | Procedure: Laser Doppler Velocimetry + Optic Adaptative Camera60 subjects with glaucoma Intervention : Laser Doppler Velocimetry + Optic Adaptative Camera |
| Retinal vein occlusion | Experimental | Procedure: Laser Doppler Velocimetry + Optic Adaptative Camera80 subjects with retinal vein occlusion including 40 with peripheric occlusion and 40 with central occlusion Intervention : Laser Doppler Velocimetry + Optic Adaptative Camera |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Willing and able to give written Informed Consent and to comply with the requirements of the study protocol
- Person affiliated to social security
- Age between 18 and 80 years
- Capable of focusing a target without ocular micro stuttering
- For healthy subject : absence of ocular and systemic pathology and no medical treatment
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Laser Doppler Velocimetry + Optic Adaptative CameraFluxometry measure while subject is sitting in front of the optic adaptative camera | Procedure or surgery | Glaucoma, Healthy subjects, Retinal vein occlusion |
Primary outcome
Change of total retinal blood flow in healthy subject
Time frame: Day 0, Day 30 to Day 60
Total retinal blood flow measurement in healthy subject at rest
7 secondary outcomes
Repeatability and reproducibility of retinal blood flow measures intra and inter session
Time frame: Day 0, Day 30 to Day 60
Change of retinal blood flow in different ages subjects
Time frame: Day 0, Day 30 to Day 60
Evaluation of the relation between retinal blood flow and vessel diameter
Time frame: Day 0, Day 30 to Day 60
Measure retinal blood flow in subject with glaucoma and compare results with healthy subjects
Time frame: Day 0
Measure retinal blood flow in subject with retinal vein occlusion and compare results with measurements made in ipsilateral non pathogenic vessels, controlateral vessels and healthy subjects.
Time frame: Day 0, Month 1, Month 2, Month 3, Month 6
Retinal blood flow evaluation after 1, 2 and 3 months after the inclusion of subject with retinal vein occlusion
Time frame: Day 0, Month 1, Month 2, Month 3
Retinal blood flow evaluation after 1, 2, 3 and 6 months after intravitreal injection of aflibercept in subject treated for macular oedema as a complication of retinal vein occlusion
Time frame: Day 0, Month 1, Month 2, Month 3, Month 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2019.
- Evaluation du flux sanguin oculaire. In: Rapport SFO 2014 - Glaucome primitif à angle ouvert.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Florent APTEL, PhD contact
anais ADOLLE contact
Florent Aptel, PhD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser Doppler Velocimetry + Optic Adaptative Camera in people with Glaucoma and Retinal Vein Occlusion, run by University Hospital, Grenoble at 1 site in France.
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 19 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 17 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Florent APTEL, PhD (faptel@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of total retinal blood flow in healthy subject (time frame: Day 0, Day 30 to Day 60). 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 17 Jun 2019.