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Study of the Retinal Vascularization by Laser Doppler Velocimetry Coupled With an Adaptive Optics Camera ( AO-LDV) (AO-LDV)

Primary Purpose

Glaucoma, Retinal Vein Occlusion

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Laser Doppler Velocimetry + Optic Adaptative Camera
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Glaucoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.
  • 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)

Sites / Locations

  • University Hospital GrenobleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Healthy subjects

Glaucoma

Retinal vein occlusion

Arm Description

120 healthy subjects in the first session and 30 in the second Intervention : Laser Doppler Velocimetry + Optic Adaptative Camera

60 subjects with glaucoma Intervention : Laser Doppler Velocimetry + Optic Adaptative Camera

80 subjects with retinal vein occlusion including 40 with peripheric occlusion and 40 with central occlusion Intervention : Laser Doppler Velocimetry + Optic Adaptative Camera

Outcomes

Primary Outcome Measures

Change of total retinal blood flow in healthy subject
Total retinal blood flow measurement in healthy subject at rest

Secondary Outcome Measures

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)
Change of retinal blood flow in different ages subjects
Total retinal blood flow measurement in different ages subjects
Evaluation of the relation between retinal blood flow and vessel diameter
Retinal blood flow and diameter of principal vessels coming from the optic disc
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
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
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
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

Full Information

First Posted
April 26, 2018
Last Updated
June 14, 2019
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT03525132
Brief Title
Study of the Retinal Vascularization by Laser Doppler Velocimetry Coupled With an Adaptive Optics Camera ( AO-LDV)
Acronym
AO-LDV
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 18, 2015 (Actual)
Primary Completion Date
March 18, 2020 (Anticipated)
Study Completion Date
September 18, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Retinal Vein Occlusion

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
290 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy subjects
Arm Type
Experimental
Arm Description
120 healthy subjects in the first session and 30 in the second Intervention : Laser Doppler Velocimetry + Optic Adaptative Camera
Arm Title
Glaucoma
Arm Type
Experimental
Arm Description
60 subjects with glaucoma Intervention : Laser Doppler Velocimetry + Optic Adaptative Camera
Arm Title
Retinal vein occlusion
Arm Type
Experimental
Arm Description
80 subjects with retinal vein occlusion including 40 with peripheric occlusion and 40 with central occlusion Intervention : Laser Doppler Velocimetry + Optic Adaptative Camera
Intervention Type
Procedure
Intervention Name(s)
Laser Doppler Velocimetry + Optic Adaptative Camera
Intervention Description
Fluxometry measure while subject is sitting in front of the optic adaptative camera
Primary Outcome Measure Information:
Title
Change of total retinal blood flow in healthy subject
Description
Total retinal blood flow measurement in healthy subject at rest
Time Frame
Day 0, Day 30 to Day 60
Secondary Outcome Measure Information:
Title
Repeatability and reproducibility of retinal blood flow measures intra and inter session
Description
Coefficient of variation for Repeatability and Reproducibility (3 measures session every 5 minutes on the same day, repeated one or two months after)
Time Frame
Day 0, Day 30 to Day 60
Title
Change of retinal blood flow in different ages subjects
Description
Total retinal blood flow measurement in different ages subjects
Time Frame
Day 0, Day 30 to Day 60
Title
Evaluation of the relation between retinal blood flow and vessel diameter
Description
Retinal blood flow and diameter of principal vessels coming from the optic disc
Time Frame
Day 0, Day 30 to Day 60
Title
Measure retinal blood flow in subject with glaucoma and compare results with healthy subjects
Description
Total retinal blood flow measured in subjects with glaucoma and age- and sex-matched healthy subjects
Time Frame
Day 0
Title
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.
Description
Total blood flow compare to the controlateral eye and healthy subject data
Time Frame
Day 0, Month 1, Month 2, Month 3, Month 6
Title
Retinal blood flow evaluation after 1, 2 and 3 months after the inclusion of subject with retinal vein occlusion
Description
Partial retinal blood flow in a occluded temporal vein compare to a healthy ipsilateral temporal vein
Time Frame
Day 0, Month 1, Month 2, Month 3
Title
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
Description
Retinal blood flow evolution will be evaluated regarding macular oedema and retinal ischaemia occurence
Time Frame
Day 0, Month 1, Month 2, Month 3, Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Florent APTEL, PhD
Email
faptel@chu-grenoble.fr
First Name & Middle Initial & Last Name or Official Title & Degree
anais ADOLLE
Email
aadolle@chu-grenoble.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florent Aptel, PhD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florent APTEL, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.em-consulte.com/em/SFO/2014/html/file_100021.html
Description
Evaluation du flux sanguin oculaire. In: Rapport SFO 2014 - Glaucome primitif à angle ouvert.

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Study of the Retinal Vascularization by Laser Doppler Velocimetry Coupled With an Adaptive Optics Camera ( AO-LDV)

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