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

Glaucoma Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03525132
• Other study ID #: 2014-A01353-44
• Status: Recruiting
• Phase: N/A
• Start date: September 18, 2015
• Est. completion date: September 18, 2020

Study information

• Verified date: June 2019
• Source: University Hospital, Grenoble
• Contact: Florent APTEL, PhD
• Email: faptel[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 290
• Est. completion date: September 18, 2020
• Est. primary completion date: March 18, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Glaucoma
• Neovascularization, Pathologic
• Retinal Vein Occlusion

Intervention

Procedure:
• Laser Doppler Velocimetry + Optic Adaptative Camera
Fluxometry measure while subject is sitting in front of the optic adaptative camera

Locations

Country	Name	City	State
France	University Hospital Grenoble	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of total retinal blood flow in healthy subject	Total retinal blood flow measurement in healthy subject at rest	Day 0, Day 30 to Day 60
Secondary	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)	Day 0, Day 30 to Day 60
Secondary	Change of retinal blood flow in different ages subjects	Total retinal blood flow measurement in different ages subjects	Day 0, Day 30 to Day 60
Secondary	Evaluation of the relation between retinal blood flow and vessel diameter	Retinal blood flow and diameter of principal vessels coming from the optic disc	Day 0, Day 30 to Day 60
Secondary	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	Day 0
Secondary	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	Day 0, Month 1, Month 2, Month 3, Month 6
Secondary	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	Day 0, Month 1, Month 2, Month 3
Secondary	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	Day 0, Month 1, Month 2, Month 3, Month 6

External Links

•   Evaluation du flux sanguin oculaire. In: Rapport SFO 2014 - Glaucome primitif à angle ouvert.