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Clinical Trials/NCT03525132
NCT03525132
Unknown
Not Applicable

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

University Hospital, Grenoble1 site in 1 country290 target enrollmentSeptember 18, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Glaucoma
Sponsor
University Hospital, Grenoble
Enrollment
290
Locations
1
Primary Endpoint
Change of total retinal blood flow in healthy subject
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 18, 2015
End Date
September 18, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Grenoble
Responsible Party
Sponsor

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Change of retinal blood flow in different ages subjects(Day 0, Day 30 to Day 60)
  • Measure retinal blood flow in subject with glaucoma and compare results with healthy subjects(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.(Day 0, Month 1, Month 2, Month 3, Month 6)
  • Repeatability and reproducibility of retinal blood flow measures intra and inter session(Day 0, Day 30 to Day 60)
  • Evaluation of the relation between retinal blood flow and vessel diameter(Day 0, Day 30 to Day 60)
  • Retinal blood flow evaluation after 1, 2 and 3 months after the inclusion of subject with retinal vein occlusion(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(Day 0, Month 1, Month 2, Month 3, Month 6)

Study Sites (1)

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